# Public Information and Confidentiality Regulations; Proposed Rule ENVIRONMENTAL PROTECTION AGENCY

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-28146

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** November 23, 1994

## Text

SUMMARY: EPA is proposing to modify certain regulations governing the
Freedom of Information Act confidential business information. This
proposal makes numerous changes intended to simplify and expedite
handling of confidential data.

DATES: Comments will be accepted until January 23, 1995.

ADDRESSES: Send or deliver written comments to Donald A. Sadowsky,
General and Information Law Division (2379), Office of General Counsel,
Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460.

FOR FURTHER INFORMATION CONTACT: Donald A. Sadowsky, Office of General
Counsel. Telephone 202/260-5469.

SUPPLEMENTARY INFORMATION: On May 20, 1975 EPA published in the Federal
Register (40 FR 21987) a proposed rule concerning procedures for the
treatment of confidential business information (CBI) submitted under
various environmental statutes. This final rule was published on
September 1, 1976 (41 FR 36902), and codified as 40 CFR part 2, subpart
B. Rules governing treatment of CBI submitted under additional
environmental statutes were promulgated on September 8, 1978 (43 FR
40003), December 18, 1985 (50 FR 51663), and July 29, 1988 (53 FR
28772). EPA published additional rules concerning confidentiality on
January 5, 1993 (58 FR 457) and February 5, 1993 (58 FR 7187).
The contents of today's preamble are listed in the following
outline:

A. Introduction
B. Up-front Assertion of and Definition of Confidentiality Claims
1. Assertion of Claims
2. Definition of Claims
3. Retroactivity
C. Sanitization and Aggregation of Data
D. Requirement to Make a Final Determination of Confidentiality When
Information Claimed as Confidential is Requested Pursuant to the
Freedom of Information Act
E. Up-front Substantiation of Confidentiality Claims Upon Submission
of Information to EPA
F. Expiration of Confidentiality Claims: Sunset Provisions
1. Rationale
2. Operation of Sunset Provisions
3. Authority
4. Other Issues
G. Eligibility of Voluntarily-submitted Information for Confidential
Treatment
1. Critical Mass
2. Definition of ``Voluntarily Submitted''
3. Requests for Substantiation
4. Advance Confidentiality Determinations
5. Class Determinations
H. Implementation of Final Determinations by Program Offices
I. Delegation of Authority to Perform Functions Under part 2
1. Final Confidentiality Determinations With Respect to Data
Submitted Under the Toxic Substances Control Act (TSCA), the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Federal
Food, Drug and Cosmetic Act (FFDCA)
2. Delegation of Part 2, Subpart B Functions to Part-time Attorneys
J. Definition of Legal Office
K. Class Determinations
L. Effect of Previous Confidentiality Determinations
1. Previous Determinations by a Federal Court or EPA Legal Office
That Information Is Not Entitled to Confidentiality
2. Previous Determinations by a Federal Agency or by a State or
Local Government Entity
M. Agency Requirements When Requesting Comments Justifying a
Confidentiality Claim; Untimely Responses
1. Agency Requirements to Verify Receipt and Response
2. Codification of Class Determination 1-85
N. Advance Notice of Disclosure of CBI to Persons Authorized to
Receive It; Recordkeeping of Disclosures
1. Form of Notice
2. Contract or Subcontract Number
3. Response to Comments
4. Records of Disclosures
O. Disclosure to Foreign Governments and International Organizations
P. Safeguarding of Confidential Information by Enrollees Under the
Senior Environmental Employment (SEE) Program
Q. Disclosure to Federal Agencies for Law Enforcement Purposes
R. Reconciliation of Program-Specific Confidentiality Provisions
with Part 2
S. Changes to Rules Governing Certain Information Obtained Under the
Clean Air Act
1. Applicability of 40 CFR 2.301, Special Rules for the Clean Air
Act
2. Basic Rules Which Apply Without Change and Assertion of Claims
3. Changes to Specific Clean Air Act Regulations Under Parts 57, 85,
and 86
4. Substantive Criteria for Confidentiality Determinations:
Production and Consumption Allowances Under Title VI
5. Confidentiality of Certain Emission Data
6. Confidentiality of Gasoline Performance Baselines
T. Changes to Rules Governing Certain Information Obtained Under the
Clean Water Act
1. Substantive Criteria for Use in Confidentiality Determinations
2. Changes to Specific Clean Water Act Regulations Under Parts 122,
123, 233, and 403
U. Changes to Rules Governing Certain Information Obtained Under the
Safe Drinking Water Act
1. Substantive Criteria Used in Confidentiality Determinations
2. Changes to Specific Safe Drinking Water Act Regulations Under
Part 145
V. Changes to Rules Governing Certain Information Obtained Under the
Solid Waste Disposal Act
1. Disclosure of Hazardous Waste Export Information
2. Changes to Specific Resource Conservation and Recovery Act
Regulations Under Parts 270, 271, and 281
3. Change to List of Authorities
W. Changes to Rules Governing Certain Information Obtained Under the
Toxic Substances Control Act
1. Signature of a Senior Management Official for Some
Confidentiality Claims and Substantiations
2. Up-front Substantiation of Confidentiality Claims for Chemical
Identity
3. Definition of Health and Safety Data
4. Disclosure of Health and Safety Data
5. Reconciliation of TSCA Program-specific Rules With Part 2 Rules
6. Sunset Provisions
X. Changes to Rules Governing Certain Information Obtained Under the
Federal Insecticide, Fungicide, and Rodenticide Act
1. Codification of 1978 Interim Procedures
2. Incorporation of FIFRA Program Provisions Regarding CBI
3. Release in Emergency Situations
4. Pesticide Export Policy
Executive Order 12866
Paperwork Reduction Act
Regulatory Flexibility Act

A. Introduction

EPA, in its data collection and information disclosure needs,
administers a variety of statutes pertaining to the protection of the
environment (e.g., the Toxic Substances Control Act, Resource
Conservation and Recovery Act, Comprehensive Environmental Response,
Compensation, and Liability Act, Clean Air Act, and Federal Water
Pollution Control Act), each with differing data collection
requirements and differing requirements for disclosure of information
to the public. The Agency collects chemical, process, waste stream,
financial, and other data from tens of thousands of facilities in many
sectors of American business. Companies frequently consider this
information vital to their competitive position, and claim it as
confidential business information (CBI).
In the course of its daily business, the Agency often has a need to
communicate CBI during the process of rulemaking, to its contractors,
in response to requests under the Freedom of Information Act (FOIA), in
litigation, etc. In particular, EPA receives a large number of FOIA
requests for an agency its size (exceeded only by three other Federal
agencies). The Agency receives upwards of 40,000 FOIA requests
annually, and the number of requests grows each year. A large number of
these requests encompass information claimed as CBI (although obtaining
CBI may not necessarily be the objective of the requestor; see section
D., below).
To manage this volume of confidential information while protecting
both the confidentiality of competitively valuable information and the
rights of FOIA requestors, EPA instituted in 40 CFR part 2, subpart B,
a set of procedures for handling and disclosing information claimed as
CBI. Although these regulations have succeeded in protecting business
information, changes in case law and in Agency workload, practice, and
statutory authority require changes in the existing part 2 regulations
in order that they may continue to effectively and efficiently guide
the Agency in its stewardship of business information. EPA proposes to
modify these regulations to eliminate unnecessary procedures, and to
streamline and expedite activities involving confidential business
information. These proposals are detailed below.

B. Up-front Assertion of and Definition of Confidentiality Claims

EPA proposes to modify Sec. 2.203 so that the Agency would protect
only information explicitly claimed as confidential.

1. Assertion of Claims

Before releasing business information to the public, either in
response to a FOIA request or otherwise, 40 CFR 2.204 requires that the
Agency determine whether the submitter of the information has claimed
the information as confidential. If the Agency's records reveal a CBI
claim for the information, part 2 provides a series of procedures
governing whether and how such information may be disclosed.
Moreover, under existing regulations, even if the submitter has not
previously asserted a CBI claim, EPA must inquire whether the submitter
wishes to assert a claim if the information is such that the submitter
might be expected to object to its release (unless, pursuant to
Sec. 2.203(a), the submitter was furnished notice when EPA requested
the information that if no CBI claim was asserted when the information
was received, EPA may make the information available to the public
without further notice). Current regulations thus frequently put Agency
employees in the position of having to guess whether a submitter would
object to disclosure of the information.
EPA believes that the submitter is in the best position to know
whether there would be an objection to disclosure, and that it is
unreasonable to expect Agency employees to, in effect, read the mind of
the submitter. Therefore, the Agency is proposing to modify Sec. 2.203
so that CBI claims are made upon submission of the information. If
review of the Agency's records revealed no claim, the Agency would have
no duty to inquire whether the submitter wished to assert a claim.
However, if it were obvious that a document not associated with a CBI
claim did in fact contain commercially valuable information, the Agency
would look into the matter.
This change would not preclude a submitter from filing a CBI claim
subsequent to submission of the information, although to the extent
that EPA has already disclosed the information or widely disseminated
it in the interim may mean that such a claim would in practical effect
be too late. This is in fact the Agency's present policy with respect
to late claims, as provided in 40 CFR 2.203(c).
One class of submitters which would need to pay close attention to
this change is third-party submitters (e.g., Company A, which provides
CBI to Company B, which then submits it to EPA). Currently, when the
Agency has possession of information developed by Company A and
submitted to EPA by Company B, the Agency must determine whether both
Company A and Company B are affected businesses that might wish to
assert confidentiality claims. Under this change, if the information
was submitted by Company B without any indication that it was claimed
as CBI, EPA would assume that the information was nonconfidential.
Thus, submitters in the position of Company A would as a matter of
course need to ensure that, when they provide CBI to someone who may in
turn provide the information to EPA, the confidentiality claim is
asserted when the information is submitted to EPA. The Agency believes
that this is consistent with prudent business practice.
Section 2.203(c) currently provides that, with respect to
information submitted before October 1, 1976, EPA must verify with the
submitter that no claim is asserted before releasing business
information, without regard to whether the submitter knew that
information not claimed as confidential may be disclosed to the public.
(For information submitted after that date, the Agency need not make
such an inquiry if the submitter has received notice that information
not claimed as confidential may be disclosed without further notice.)
The purpose for this distinction was to protect companies who had
submitted information before EPA's regulatory policies for protecting
CBI were originally established.
EPA proposes to eliminate the distinction for information submitted
before October 1, 1976. The practical effect of this change would be
that persons who submitted information prior to October 1, 1976 and who
were given written notice at the time that information not claimed as
confidential may be disclosed to the public would no longer be asked at
a later date whether they wished to assert a CBI claim. If, with
respect to such information, the Agency had no record that such notice
had been given, EPA would continue to inquire, where appropriate,
whether the person wished to assert a CBI claim for the information.
The Agency believes that when data 17 years old or older were not
originally claimed as confidential, and the submitter was given notice
that a confidentiality claim must be asserted in order to protect the
information, further inquiry is not required.

2. Definition of Claims

Even where a submitter has asserted a confidentiality claim, the
claim is frequently asserted merely by claiming an entire submission as
confidential, even though very few documents are composed entirely of
confidential business information. Where such a blanket claim has been
made, the Agency has no way of knowing what specific information in the
submission is claimed as confidential. Consequently, Agency employees
may be faced with great difficulty in redacting (sanitizing) the
documents, or must ask the submitter in each case which information in
the submission is subject to a CBI claim. When EPA is dealing with
masses of data from hundreds or thousands of submitters, uncertainty as
to what specific confidentiality claims are being asserted can be a
significant barrier to Agency action. It is therefore important that
all CBI claims be asserted with specificity. Nonetheless, the Agency
recognizes that there are rare situations in which an entire document
may be entitled to confidentiality.
EPA is therefore proposing to modify Sec. 2.203(b) to provide that
any confidentiality claim for an entire document be deemed ineffective
(i.e., EPA would treat the document as if it were not claimed as CBI)
unless at the time of assertion the submitter substantiates why the
entire document (as opposed to portions of the document) should be
maintained as confidential.

3. Retroactivity

The proposed provisions governing up-front assertion of claims and
substantiation of blanket claims for an entire document would apply
only to data submitted on or after the date of the final rule.

C. Sanitization and Aggregation of Data

The Agency proposes to modify Sec. 2.202(f) to clarify that a
submitter's consent is not required for disclosure of sanitized or
aggregated data.
EPA frequently needs to disclose to the public (e.g., pursuant to a
FOIA request or in discussions of the bases for Agency decisions) non-
confidential information derived from data supplied by businesses and
claimed as confidential. Such releases might take the form of industry-
wide data aggregated into a non-confidential figure, or sanitized
documents where all information that could identify the submitters has
been removed.
Sanitization and aggregation of submissions require care to ensure
that the information released to the public cannot be used by a
knowledgeable person to back-calculate to information claimed as CBI.
EPA employees releasing such information frequently have questions
concerning the steps to be taken to ensure that CBI is not disclosed.
Existing Agency regulations at 40 CFR 2.202(f) provide an uncertain
guide, merely stating that EPA ``should consider whether it is possible
to obtain the affected business's consent'' to this kind of disclosure.
However, releasing properly sanitized or aggregated data does not
disclose information claimed as confidential, and the consent of the
submitter to such release is not necessary.
The Agency has long disclosed aggregated data submitted pursuant to
the Toxic Substances Control Act (TSCA), without the consent of the
submitter, in accordance with published protocols. See e.g., 48 FR 6539
(February 14, 1983). Such disclosures have successfully protected
confidential data.
EPA desires to clarify its policy with respect to sanitized and
aggregated data. The Agency believes it should provide the public with
useful information while ensuring that data claimed as confidential is
given sufficient protection. Therefore, the proposed rule contains
language modifying Sec. 2.202(f) to clarify that the submitter's
consent is not required for disclosure of aggregated or sanitized
information, but that: (1) When disclosing sanitized copies, EPA
offices must ensure that the portions of the documents which are
disclosed do not contain information claimed as confidential; and (2)
all disclosures of aggregated numerical data must be made using a
procedure on which an EPA legal office (Office of General Counsel or
Office of Regional Counsel) has been consulted. In consultation with an
EPA legal office, a program would develop and subsequently follow a set
of principles involving confidentiality safeguards and allowing
scientific or technical adaptability to specific aggregation needs.

D. Requirement to Make a Final Determination of Confidentiality
When Information Claimed as Confidential is Requested Pursuant to
the Freedom of Information Act

EPA proposes to modify its public information and confidentiality
regulations to require final confidentiality determinations only where
the requestor has expressly requested information claimed as
confidential.
When EPA receives a request pursuant to FOIA which encompasses
information claimed as confidential, existing regulations at 40 CFR
2.204(d)(1) require that the request be initially denied with respect
to information subject to a confidentiality claim (unless the
information is clearly not entitled to confidentiality), pending a
final determination by an Agency legal office of the eligibility of the
information for confidential treatment under exemption 4 of FOIA. This
determination must be made irrespective of whether the requestor
appeals the initial denial. Such treatment of exemption 4 denials is in
contrast to legal determinations made with respect to denials of
records pursuant to other exemptions of FOIA, which under 40 CFR 2.115
(contained in subpart A of part 2, governing requests for information)
are made only upon appeal of the denial. The Agency originally devised
this process as a means of meeting its obligations under FOIA to make a
determination of releasability and adhere to the response times in FOIA
of ten days to the extent possible: for most CBI claims, detailed
information from the submitter is necessary to make a determination of
confidentiality, and making such a final determination requires far
more than ten days.
However, making a final determination of confidentiality can be
time-consuming and resource intensive for EPA, and requires the
submitter to prepare a justification of why the information is entitled
to confidentiality. The Agency's experience in responding to such FOIA
requests is that requestors are frequently not interested in
information claimed as confidential, and the exercise of determining
confidentiality in such cases is unnecessary.
EPA is therefore proposing to modify its subpart A provisions so as
to require final determinations of confidentiality only where the
requestor has expressly indicated a desire for information claimed as
confidential. Under the proposed change, Sec. 2.111 (subpart A) and
Sec. 2.204(a)(1) (subpart B) would be modified to create a presumption,
rebuttable by the FOIA request itself, that the requestor does not
desire access to information claimed as CBI. In other words, if a FOIA
request which would otherwise encompass information claimed as business
confidential is silent as to whether information claimed as CBI is
desired by the requestor, EPA would presume that the requestor does not
desire such information. If, however, the request states that access to
information claimed as CBI is desired, the Agency would treat such
requests as it has in the past, i.e., making an initial denial with a
subsequent determination as to whether the subject information is
entitled to confidential treatment.
EPA realizes that some requestors might not be aware of the
necessity to specify that they desire access to information claimed as
confidential, or might not know, without first learning what records
are in EPA's possession, whether they do in fact require access to
information claimed as CBI. Thus, if the Agency merely ignored the
portion of the request pertaining to information claimed as CBI, some
requestors might never learn that there is pertinent information in the
Agency's files which is claimed as confidential. Therefore, Sec. 2.111
would provide that the response to such a FOIA request must state that
the Agency is presuming that the request does not encompass information
claimed as CBI, and must include in the response a list or description
of that information claimed as CBI which EPA was presuming not to be
subject to the FOIA request. The requestor could then choose to submit
another FOIA request for that information.
Authority to create such a presumption can be found in FOIA itself.
Although it is commonly believed that FOIA requires Federal agencies to
respond to every request under FOIA which reasonably describes the
records sought, FOIA requires that such requests be made ``in
accordance with published rules stating the * * * procedures to be
followed.'' 5 U.S.C. 552(a)(3)(B). The rebuttable presumption that CBI
is not requested would be a procedure under 5 U.S.C. 552(a)(3)(B) which
is intended to save both EPA and CBI submitters time and resources, as
well as to improve responsiveness to FOIA requests by eliminating
unnecessary determinations of confidentiality.
EPA considered a second alternative which adheres more closely to
current Agency procedures. Under this alternative, EPA would not make
any presumptions as to the scope of the request, and would continue to
issue denials with respect to information claimed as CBI, solely on the
basis of the confidentiality claim. However, the Agency would not
request substantiation or issue a final confidentiality determination
unless the requestor appealed the denial. The Agency considers this
alternative less desirable because even for those requestors who
specifically state a desire for CBI in their request, the lengthy
process of substantiation and determination would not begin until the
request was appealed. Additionally, this alternative raises a question
as to whether EPA would be meeting its obligations under paragraph
(a)(3) of FOIA to make non-exempt records available to requestors if it
denied requested records merely on the basis of a claim of
confidentiality without determining whether in fact such records
qualify for withholding under exemption 4 of FOIA.
A third alternative consists of implementing the presumption
discussed above and, with respect to those FOIA requests which
specifically request CBI, only making a final confidentiality
determination if the request is appealed (under the theory that
requestors who initially indicate a desire for CBI may decide not to
appeal once they see a list of what information is actually claimed).
This alternative would be the least burdensome for the Agency, but
suffers from the same difficulties as the previous alternative; it also
would only be worthwhile if a significant proportion of those
requestors specifically asking for CBI would in fact not appeal the
initial denial.
A fourth alternative is making no change to the present procedures.
EPA requests comments on all alternatives.

E. Up-front Substantiation of Confidentiality Claims Upon Submission of
Information to EPA

EPA proposes to amend Sec. 2.203(b) to provide a framework for more
specific regulatory requirements that CBI claims for specified types of
information must be accompanied by a substantiation at the time of
submission.
Pursuant to Sec. 2.204, when the Agency either; (1) Is required by
a FOIA request, or (2) desires for any purpose, to determine whether
information in its possession is entitled to confidentiality, EPA
requires the submitter to substantiate its confidentiality claim. The
submitter must submit information which, among other things, sets
forth:
(1) What portion of the information the submitter believes is
entitled to confidential treatment;
(2) The length of time for which confidential treatment is desired;
(3) Measures taken by the business to prevent undesired disclosure
to others;
(4) The extent to which the information has already been disclosed
to others; and
(5) Why release of the information would result in substantial
harmful effects to the business' competitive position in the
marketplace. 40 CFR 2.204(e)(4).
EPA's general confidentiality regulations at 40 CFR part 2 do not
require a CBI claim to be substantiated upon submission of the
information, although some program-specific regulations contain an up-
front substantiation requirement. See, e.g., 40 CFR 710.38 and
720.90(b)(2), implementing the Toxic Substances Control Act.
Submission of substantiation material at a later date can be
somewhat problematic, both for the submitter and the Agency. It may be
more difficult for the submitter to compile responsive information when
requested to do so by the Agency long after the information claimed as
confidential has been submitted to EPA. Not having this information on
hand can impair the Agency's ability to perform some of its functions
(especially responding to FOIA requests which seek information that
contains CBI) in an expeditious manner.
The Agency is proposing to amend Sec. 2.203(b) to explicitly
provide that up-front substantiation requirements may be promulgated on
a program-by-program basis by specific regulation. Existing up-front
substantiation requirements would not be affected by this change. The
need for such a requirement varies among programs and data collections,
dependent in part upon the public interest in the information, the
frequency of CBI claims, and the frequency of insupportable claims. For
example, in programs where CBI claims are infrequent, the impact of
confidentiality claims on both the Agency and FOIA requestors is low.
Therefore, the proposed amendment would not be self-executing: up-front
substantiation requirements would be imposed for specified classes of
information by notice and comment rulemaking. This approach would give
the Agency the flexibility to impose such a requirement only where
necessary.
The Agency believes that such a provision would be beneficial for
two principal reasons. First, it would enable EPA to deal in a more
expeditious fashion with FOIA requests which seek information
containing CBI. In general, such requests can take a long time to
resolve, in part due to the process of requesting (and receiving) a
substantiation from the submitter. Having the substantiation on file
would expedite the process.
Second, the Agency believes that an up-front substantiation
requirement would help reduce those CBI claims made as a matter of
course and induce submitters to be more selective in their CBI claims
by requesting CBI protection only for specific information that truly
needs to be protected. The Agency is not seeking to limit the type of
information which a party may claim as CBI. Rather, EPA believes that
the introduction of a requirement to justify a CBI claim upon
submission of the underlying material would induce submitters to
request CBI treatment only for information which is truly confidential,
thereby reducing the amount of confidentiality claims actually
submitted to the Agency. EPA anticipates that this will expedite review
of data provided to the Agency, allowing EPA to make determinations
concerning CBI claims and respond to FOIA requests more expeditiously.
Finally, the Agency does not believe that this amendment would chill a
submitter's assertion of a claim for information which is truly
entitled to confidential treatment. If information is important enough
to be worth confidential protection, it is worth substantiating the
claim. The proposed amendment does not codify uniform substantiation
questions, but requires all up-front substantiations to address at the
least the factors in 40 CFR 2.208 (criteria for confidentiality).
Authority for an up-front substantiation requirement stems both
from the statutes administered by EPA (e.g., section 308 of the Clean
Water Act provides that all information collected under this section
``shall be available to the public, except that upon a showing
satisfactory to the Administrator'' the information is entitled to
confidential protection), and the Agency's inherent authority to
promulgate regulations governing disclosure under the Freedom of
Information Act, the Trade Secrets Act, and other statutes (cf.
discussion of sunset provisions in section F., below).

F. Expiration of Confidentiality Claims: Sunset Provisions

EPA proposes to add a new Sec. 2.216, which would allow selected
CBI claims to expire unless reasserted.

1. Rationale

The commercial utility of information will usually decrease over
time: new processes are developed, and market forces change. As the
proprietary value of information lessens, at a certain point in time
the information may no longer be entitled to confidentiality. It is
then appropriate to end confidential treatment. EPA is proposing to
allow the promulgation of sunset provisions to identify such points in
time.
EPA has long taken the position that ``[p]ublic participation
cannot be effective unless meaningful information is made available to
the interested persons.'' 48 FR 21737 (May 13, 1983). Information
submitted to the Agency under a claim of confidentiality interferes
with EPA's ability to inform the public. EPA recognizes its duty to
safeguard confidential business information, but believes there are
confidentiality claims that are no longer valid. Where there is no
longer a reason for a confidentiality claim, the subject information
should be declassified to maximize the amount of information publicly
available to facilitate public participation in the regulatory process.

2. Operation of Sunset Provisions

EPA proposes to add a new section, Sec. 2.216, to establish a
framework within which the Agency may promulgate regulations requiring
that a previously asserted confidentiality claim be reasserted during a
specified period. The period could follow either submission of the
information or the occurrence of a specified event. Examples of
hypothetical periods are five years after submission of the
information, or within 90 days of granting of a United States patent
protecting the information. Because this framework would be implemented
by program-specific regulations, Sec. 2.216 would not in itself cause
any confidentiality claims to expire. Rather, the provision is intended
to establish the necessary components of a regulation which provides
for expiration of confidentiality claims.
All submitters asserting confidentiality claims subject to a sunset
provision would be given an opportunity to reassert the claim. In
addition, the provision would only be applied prospectively.
A regulation with a sunset provision would establish the various
parameters of the provision. These include the class of information to
which the sunset applies, the period of time or event to occur before
the confidentiality claim expires, and the procedures to follow to
reassert the claim. A claim which is not reasserted in accordance with
the stated procedures would be deemed waived. A specific sunset
provision might include, along with a requirement to reassert the
claim, a requirement to substantiate (or resubstantiate) the claim at
the time of reassertion.
Submitters would be expected to know what information is subject to
a sunset provision and the time when reassertion is due. Since the
existence of the sunset provision in Agency regulations would itself
provide submitters with notice of the reassertion requirement, the
Agency would not be required to provide further notice of either the
sunset provision or the opportunity to reassert the claim. However,
program offices would not be precluded from establishing a policy of
routinely providing such further notice.
Where the same information was submitted several times to the
Agency, each submission which is subject to a sunset provision would
carry its own sunset period. An expired confidentiality claim on one
submission would not automatically eliminate the confidentiality claim
for a second submission, because the link between the information and
the second submission might itself be protectible information,
notwithstanding the fact that the information in the first submission
is now public. Nonetheless, such situations are unlikely, and the
expiration of the claim for the first submission, causing that
information to enter the public domain, would play a significant role
in determining whether the second submission was now also in the public
domain.

3. Authority

EPA believes that the authority to promulgate requirements for
maintaining confidentiality claims is inherent in the environmental
statutes administered by the Agency which provide that information may
be protected upon a showing made to the Administrator that the
information is entitled to confidentiality (see, e.g., section 308 of
the Clean Water Act). EPA administers numerous statutes which require
information to be submitted to the Agency. These statutes contain
provisions which either specify the procedures for claiming
confidential status or generally describe confidential treatment for
information, in concert with general rulemaking authority to implement
the statute. These statutory authorities form the basis for the current
EPA confidentiality regulations.
For example, the Toxic Substances Control Act (TSCA) states that
``[a] designation (of confidentiality) under this chapter shall be made
in writing and in such manner as the Administrator may prescribe''. 15
U.S.C. 2613(c)(1)(B). EPA has previously construed this provision to
authorize a sunset provision which causes certain confidentiality
claims associated with Premanufacture Notifications to expire upon
submission of a Notice of Commencement, unless the claim is reasserted
at that time. See 40 CFR 720.85.
Implicit in the prohibition on disclosing confidential information
without authority to do so (contained in many of the statutes
administered by the Agency and the Trade Secrets Act, 18 U.S.C. 1905)
is the authority to provide for assertion of claims and to take those
steps necessary to determine which information claimed as CBI is
actually entitled to confidentiality. Because information may lose its
eligibility for confidential treatment over time, it is a legitimate
exercise of statutory authority to reexamine confidentiality claims in
a systematic manner via regulations which allow confidentiality claims
to expire.
In addition, EPA seeks to more fully embrace the policy stated in
Executive Order 12600 Sec. 3(b), 3 CFR, 1987 Comp., p. 236, which
explicitly contemplates that Federal agencies may provide for the
expiration of confidentiality claims on information submitted to the
Federal Government on or after January 1, 1988. The order provides that
``agency procedures may provide for the expiration, after a specified
period of time or change in circumstances, of designations of
competitive harm made by submitters.''

4. Other Issues

EPA has considered a number of different issues before arriving at
this proposal. First, EPA has considered how broadly a sunset provision
should apply. Specifically, the Agency considered whether regulations
should provide for a uniform sunset requirement for all submissions,
Agency-wide, or for a program-by-program sunset requirement based on
the individual program's needs. The Agency has concluded that, at a
minimum, the need for a sunset provision and the determination of the
appropriate sunset period depend upon, among other things, the nature
of the information, the public interest in the information, and the
frequency of confidentiality claims, all of which vary according to the
type of information involved. Therefore, the Agency has decided that it
is more appropriate that sunset provisions be put into place on a
program-by-program basis. The purpose of proposed Sec. 2.216 is to
establish a regulatory framework for how sunset provisions would
operate.
EPA has also considered whether the Agency should be required to
remind submitters when their claims are about to expire. EPA is
proposing not to provide such a reminder, but is placing on submitters
the responsibility for ensuring that they reassert the confidentiality
claim at the appropriate time. EPA believes that putting the burden on
the Agency to notify the submitter before expiration of the claim would
be little different than what is provided under existing regulations,
because EPA can already in effect give a submitter notice that a claim
will expire unless the submitter responds to the notice. Under current
Sec. 2.204(e) EPA can require a submitter to substantiate a claim; if
the submitter does not respond in a timely manner, under Sec. 2.205(d)
the claim is deemed waived. Although making submitters responsible for
determining when action must be taken would require them to maintain
the necessary information to make such a determination, it is a matter
of sound business practice to keep track of what information has been
submitted to EPA and what actions are required to safeguard the
information (and when to take such actions). Those claims which are
worth asserting for a significant period of time are also worth the
associated recordkeeping.
Finally, EPA has considered whether submitters should be required
to substantiate a reasserted claim at the time of the reassertion. EPA
believes that the answer to this question depends upon factors such as
the nature of the data, the likelihood that old data would continue to
need confidential treatment, and the uses made by the Agency and the
public of such data. Therefore, EPA proposes to leave that issue to be
decided on a case-by-case basis during promulgation of specific sunset
provisions. However, such a requirement could be placed in an
individual regulation, where appropriate.

G. Eligibility of Voluntarily-submitted Information for
Confidential Treatment

EPA proposes to amend several sections in part 2 to make the
regulations consistent with the recent decision in Critical Mass v.
Nuclear Regulatory Commission, 975 F.2d 871 (D.C. Cir. 1992), cert.
denied, 113 S. Ct. 1579 (1993).

1. Critical Mass

At the time of the Agency's original promulgation of its
confidentiality regulations at 40 CFR part 2, subpart B, the applicable
standard for whether information was entitled to confidential treatment
under Exemption 4 of the Freedom of Information Act was set forth in
National Parks and Conservation Association v. Morton, 498 F.2d 765
(D.C. Cir. 1974). In National Parks, the Court set forth a two-part
test, stating that ``[c]ommercial or financial matter is `confidential'
* * * if disclosure of the information is likely * * * either * * * (1)
to impair the Government's ability to obtain necessary information in
the future; or (2) to cause substantial harm to the competitive
position of the person from whom the information was obtained.'' 498
F.2d at 770.
In Critical Mass, the D.C. Circuit revisited the definition of
``confidential'' set forth in the National Parks case. The Court did
not abandon the definition of ``confidential'' presented in National
Parks, but chose to modify its application. The categorical rule
developed by the Court states that ``financial or commercial
information provided to the Government on a voluntary basis is
confidential for the purpose of Exemption 4 if it is of a kind that
would customarily not be released to the public by the person from whom
it was obtained.'' 975 F.2d at 879. Therefore, if commercial or
financial information obtained from a person is submitted voluntarily
and would not customarily be disclosed by the submitter, it is presumed
confidential without requiring any examination of the competitive harm
portion of the National Parks test. EPA proposes to amend the criteria
for confidentiality in Sec. 2.208 accordingly.
Note that information which under Critical Mass is entitled to
confidentiality pursuant to exemption 4 of FOIA may still be required
to be disclosed to the public via independent statutory authority. For
example, emission data which could have been collected pursuant to
section 114 of the Clean Air Act but was in fact voluntarily submitted
to EPA would not be eligible for confidential treatment, due to the
requirement in section 114 that emission data be available to the
public.

2. Definition of ``Voluntarily Submitted''

Section 2.201(i) currently provides that for information to be
considered voluntarily submitted it must be information whose
submission EPA had no statutory or contractual authority to require.
However, in Critical Mass, information which the court called
voluntarily submitted was within the statutory authority of the Nuclear
Regulatory Commission to require from the regulated industry, although
the Commission had not in fact required its submission; rather, the
Commission had obtained the information on a voluntary basis from an
industry association. 975 F.2d at 880. Because the Sec. 2.201(i)
definition appears to conflict with Critical Mass, and the courts have
only begun to determine when information is submitted voluntarily, EPA
proposes to delete Sec. 2.201(i) altogether.

3. Requests for Substantiation

Because the confidentiality of voluntarily submitted information is
not dependent on competitive harm, there is no need for the Agency to
require submitters to justify why disclosure of such information is
likely to cause substantial competitive harm. Therefore, EPA proposes
to modify the substantiation requirements at Sec. 2.204(e)(4) to allow
the action office to not request substantiation on competitive harm
when the action office believes the information was submitted
voluntarily. The Agency would ask questions eliciting information which
pertains to whether such information would customarily be disclosed to
the public by the submitter. If the EPA legal office which subsequently
determines the information's eligibility for confidential treatment
believes that the information is in fact not voluntarily submitted, the
legal office would request the submitter to substantiate the likelihood
of competitive harm, pursuant to the procedures of Sec. 2.204(e).

4. Advance Confidentiality Determinations

Under Sec. 2.206, EPA may make an advance determination of
confidentiality before information is officially submitted to the
Agency, provided that: (1) EPA has requested or demanded that a
business furnish business information to the Agency, (2) the submitter
asserts that the information would constitute voluntarily submitted
information, and (3) the submitter will voluntarily submit the
information for use by EPA only if EPA first determines that the
information is entitled to confidential treatment. Section 2.206
currently cites the definition of voluntarily submitted in
Sec. 2.201(i), and requires substantiation of competitive harm. EPA
proposes to delete both the reference to Sec. 2.201(i) and the
requirement to substantiate competitive harm.
EPA also proposes to remove the words ``or demanded'' from
Sec. 2.206(a)(1). This change would clarify that where EPA demands
submission of information pursuant to its authority, the information
cannot be deemed voluntarily submitted.

5. Class Determinations

Under Sec. 2.207, EPA may make determinations pertaining to, among
other things, whether information is submitted voluntarily (for a more
detailed discussion of class determinations, see section K., below).
Section 2.207 currently refers to the Sec. 2.201(i) definition of
voluntarily submitted information; this reference would be deleted.

H. Implementation of Final Determinations by Program Offices

EPA proposes to amend Sec. 2.205(f) to permit program offices to
grant extensions of time and release information pursuant to final
confidentiality determinations made by those offices under
Sec. 2.204(d)(2).
Final determinations of confidentiality are normally made by a
legal office (General Counsel or Regional Counsel) under Sec. 2.205.
However, when information is clearly not entitled to confidentiality,
under Sec. 2.204(d)(2) any office may make a final confidentiality
determination. Section 2.205(f) provides procedures to follow any
determination that information is not entitled to confidentiality
(either under Sec. 2.205 or Sec. 2.204(d)(2)): advance notification to
the submitter of disclosure of the information within a certain period
(normally ten days), extension of the time period in certain cases, and
disclosure of the information if the submitter does not file suit
during this period to enjoin disclosure.
Section 2.205(f) does not clearly state that a program office may
grant extensions of the time period and ultimately disclose the
information upon its expiration when the final determination was
drafted by the program office, although such a practice would be
logical and efficient. EPA proposes to amend Sec. 2.205(f) accordingly.

I. Delegation of Authority to Perform Functions Under Part 2

EPA proposes to amend several sections to give the General Counsel
greater flexibility in delegating part 2 functions.
40 CFR 2.205(i), as supplemented by Sec. 2.306(e)(1) (governing
TSCA confidentiality), Sec. 2.307(e)(1) (governing confidentiality
under the Federal Insecticide, Fungicide, and Rodenticide Act), and
Sec. 2.308(f)(1) (governing confidentiality under the Federal Food,
Drug and Cosmetic Act), sets limits on who can take certain actions
under part 2, such as issuing final determinations of confidentiality
under Sec. 2.205. Following are proposals to amend these limitations to
give EPA more flexibility in its internal operations.

1. Final Confidentiality Determinations With Respect to Data Submitted
Under the Toxic Substances Control Act (TSCA), the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and the Federal Food, Drug and
Cosmetic Act (FFDCA)

Section 2.205(i) provides that final confidentiality determinations
may be made by EPA legal offices (Office of General Counsel or Offices
of Regional Counsel). However, Secs. 2.306(e)(1), 2.307(e)(1), and
2.308(f)(1) provide that ``the General Counsel (or his designee),
rather than the Regional Counsel,'' may make confidentiality
determinations for data submitted pursuant to TSCA, FIFRA, or FFDCA,
respectively. The Office of General Counsel has consistently
interpreted these provisions to allow the General Counsel to designate
the Regional Counsels to make TSCA, FIFRA and FFDCA confidentiality
determinations. EPA proposes to amend these provisions to provide that
Regional Counsels may make final determinations under TSCA, FIFRA, and
FFDCA. (Note: under revisions discussed below, Sec. 2.306(e) would be
redesignated as Sec. 2.306(f).)

2. Delegation of Part 2, Subpart B Functions to Part-time Attorneys

Section 2.205(i) provides that the General Counsel ``may redelegate
any or all of his authority under this subpart to any attorney employed
by EPA on a full-time basis under the General Counsel's supervision.''
The section contains similar language regarding Regional Counsels. The
limitation to full-time attorneys was originally promulgated to be an
internal management tool for the Agency. However, the Agency now
believes that the decision as to the ability of part-time attorneys to
fill a function is best left to the judgment of the delegating official
rather than being constrained by regulation, and proposes to remove
this limitation.

J. Definition of Legal Office

EPA proposes to amend Sec. 2.201(n) to reflect the reorganization
of 1990 involving the reporting relationships of Regional Counsels to
the Office of Enforcement and Compliance Assurance and the Office of
General Counsel.
Under part 2 regulations, some actions may be taken by any office
(e.g., initially denying a FOIA request encompassing CBI), while some
actions may only be taken by a ``legal office'' (e.g., final
confidentiality determinations pursuant to Sec. 2.205(a)). Section
Sec. 2.201(n) defines an EPA legal office as ``the EPA General Counsel,
and any EPA office over which the General Counsel exercises supervisory
authority, including the various Offices of Regional Counsel.''
Since 1990, the Offices of Regional Counsel (ORC) have reported to
EPA's Office of Enforcement (now the Office of Enforcement and
Compliance Assurance), rather than the Office of General Counsel,
although ORC maintains the same functions with respect to EPA's
confidentiality regulations. Therefore, EPA proposes to amend
Sec. 2.201(n) to reflect this organizational change.

K. Class Determinations

EPA proposes to modify Sec. 2.207 to require publication in the
Federal Register of future class determinations.
Under Sec. 2.207, EPA may issue a class determination finding that
there is a class of information such that one or more characteristics
common to all items in the class will necessarily result in identical
treatment for each such item under one or more of the provisions in
EPA's confidentiality regulations. EPA has issued seventeen class
determinations.
Most commonly, a class determination states whether the class is
entitled to confidentiality. When the Agency is contemplating
disclosure of information subject to a class determination, the notice
of opportunity to submit comments referred to in Secs. 2.204(d)(1)(ii)
and 2.205(b) may be modified to reflect the fact that the class
determination has made unnecessary the submission of materials
pertinent to one or more issues.
EPA has generally published such class determinations in the
Federal Register, and Sec. 2.207(d) provides that ``[t]he purpose of a
class determination is simply to make known the Agency's position
regarding the manner in which information within the class will be
treated.'' Nonetheless, Sec. 2.207 currently does not require
publication. Although class determinations are not rules subject to the
notice and comment requirements of the Administrative Procedures Act,
EPA believes that publication of all future class determinations in the
Federal Register would be consistent with the purpose of making known
the Agency's position on the class, and is in the best interests of
submitters of confidential information, FOIA requestors, and the Agency
itself. Publication would also be consistent with the requirement in
the Freedom of Information Act, 5 U.S.C. 552(a)(1)(D), that agencies
publish in the Federal Register ``interpretations of general
applicability formulated and adopted by the agency.'' Therefore, EPA is
proposing to modify Sec. 2.207 to provide for publication in the
Federal Register of future class determinations.

L. Effect of Previous Confidentiality Determinations

EPA proposes to modify Sec. 2.204(b) to clarify (or in some
situations increase) the ability of the Agency to rely on previous
confidentiality determinations by EPA, Federal courts, and State and
local governments.
When EPA is determining whether information is entitled to
confidentiality, Sec. 2.204(b) requires the Agency to ascertain whether
there has been a previous confidentiality determination by a Federal
court or EPA legal office. The normal method of learning about previous
determinations is to ask the submitter, who would have the most
comprehensive file of relevant determinations. If the information has
previously been determined by a Federal court or EPA legal office to be
entitled to confidentiality, the Agency does not reexamine the issue.
Instead, the Agency denies any pending FOIA requests for the
information, and considers the matter closed, unless the previous
determination was issued by EPA and the Agency now believes that the
previous determination was erroneous. Pursuant to Sec. 2.205(h), a
legal office may modify a previous determination believed to be
erroneous.
The purpose of Sec. 2.204(b) is to save the time and resources
otherwise required to decide the issue anew. However, Sec. 2.204(b)
fails to provide for any effect of either (1) A previous determination
by a Federal court or EPA legal office that the information is not
entitled to confidentiality, or (2) a determination by a State or local
governmental body. Additional savings could be realized if such
determinations had similar effect.

1. Previous Determinations by a Federal Court or EPA Legal Office That
Information Is Not Entitled to Confidentiality

Arguably, such situations are already covered by existing
regulations. Section 2.204(d)(2) allows an EPA office to issue a
determination that information is clearly not entitled to
confidentiality, without giving the submitter an opportunity to
substantiate the claim. In the Federal Register of September 1, 1976
(41 FR 36920, discussion of comment #16) the Agency stated that such a
determination can be made where ``EPA's position on the matter is
already clear and there is nothing further to consider.'' A previous
confidentiality determination clearly falls within that category.
Furthermore, on page 36919, in response to comment #13, the Agency
stated that ``[e]ven if a prior determination states that information
of a certain type is not entitled to confidential treatment, a business
should be afforded the opportunity to seek judicial review.'' The
Agency did not in that sentence discuss an additional opportunity for
the submitter to substantiate the CBI claim, indicating that a
Sec. 2.204(d)(2) determination was contemplated by EPA as the
appropriate procedure when the Agency has previously determined that
the information was not entitled to confidentiality.
Nonetheless, in the interest of clarity, EPA now proposes to amend
Sec. 2.204(b) to make it explicit that a previous determination by an
EPA legal office or a Federal court denying confidentiality is grounds
for a Sec. 2.204(d)(2) determination.

2. Previous Determinations by a Federal Agency or by a State or Local
Government Entity

Confidentiality determinations by other Federal agencies or by
State and local governments are not binding upon EPA, and in the case
of State or local determinations may be based upon inapplicable State
or local laws. Thus, the legal opinion of another Federal agency or of
a State or local government as to whether information is entitled to
confidentiality could only be useful to EPA in an advisory capacity.
However, where the government entity has determined that the
information is not entitled to confidentiality and has released the
information to the public based upon that determination, the
information has now entered the public domain, and is no longer
entitled to confidentiality, regardless of whether EPA agrees with the
rationale for the original determination by the governmental entity.
Therefore, the Agency proposes to modify Sec. 2.204(b) to provide that,
where another Federal agency or a State or local government entity has
determined that information is not entitled to confidentiality and the
information is available from that entity (e.g., if the submitter has
exhausted all administrative remedies with the governmental entity),
the information is clearly not entitled to confidentiality under
Sec. 2.204(d)(2).

M. Agency Requirements When Requesting Comments Justifying a
Confidentiality Claim; Untimely Responses

EPA proposes to amend Sec. 2.205 to expedite procedures for sending
out requests for substantiation and to codify Class Determination 1-85,
regarding untimely responses to substantiation requests.
When EPA is determining whether information claimed as confidential
is entitled to confidentiality, and asks an affected business to
substantiate a CBI claim, the business is given a period (usually 15
working days) to submit its substantiation. 40 CFR 2.204(e). Failure to
submit the substantiation within this period (or any approved extension
of time) results in a finding that the submitter has waived its claim.
40 CFR 2.205(d)(1).

1. Agency Requirements to Verify Receipt and Response

Because of the adverse consequences of such failure, EPA's
regulations require the Agency to go to considerable lengths to ensure
that the submitter files a response to the substantiation request:
(1) EPA must send the substantiation request to the submitter via
certified mail (return receipt requested), by personal delivery, or by
other means which allows verification of the fact and date of receipt;
(2) The Agency must orally inform a responsible representative of
the business that the business should expect to receive the written
notice, and must request that the business contact the EPA office if
the written notice has not been received within a few days; and
(3) If the substantiation has not been received within the required
period, the Agency must contact the affected business, ask whether the
substantiation had been lost in transmission, and provide an
opportunity to resubmit the comments. 40 CFR 2.204(e) and 2.205(b).
Although EPA continues to believe it is appropriate to adequately
document receipt of the substantiation request and to verify that the
substantiation was indeed submitted (given the size of the Agency and
the chances that a submission might be significantly delayed in finding
its way to its intended recipient), the advance oral notification is
not necessary, since businesses as a matter of course do read and
respond to their mail. Therefore, EPA proposes to delete the
requirement in Sec. 2.204(e)(3) that submitters be notified orally of
the impending substantiation request. Note that EPA would continue to
send the request by means which allow verification of receipt.

2. Codification of Class Determination 1-85

Section 2.205(d)(1) provides that if an EPA legal office finds that
a submitter has not filed a timely substantiation, the claim is waived.
To avoid the necessity of a legal office making such a finding each
time a submitter fails to file a timely substantiation, in 1985 EPA
issued Class Determination 1-85. This class determination provides that
a business has waived its confidentiality claim, and therefore that no
confidentiality claim applies to the relevant information, if both of
the following conditions are met:
(1) The EPA office designated to receive the business' comments has
not received those comments within the specified time period or an
approved extension thereof (see 40 CFR 2.205(b)(2)) as defined by EPA's
regulations (40 CFR 2.205(b)(1)-(4)) (after making appropriate inquiry
on whether the comments were lost in transmission, as required by 40
CFR 2.205(b)(4)); and
(2) The business was notified in writing at the time comments were
solicited that failure to submit timely comments would be construed as
a waiver of the business' claim. The effect of such a waiver is that
(unless some other business has claimed the information as CBI) no
confidentiality claim applies, and the information may be made
available to the public.
Although the class determination, pursuant to Sec. 2.207, is
effective in allowing disclosure of such information without further
notice, it would be clearer if 1-85 were codified in Sec. 2.204(d),
instead of requiring an additional non-regulatory document. EPA
therefore proposes to modify Sec. 2.204(d)(3), and delete
Sec. 2.205(d)(1), accordingly.

N. Advance Notice of Disclosure of CBI to Persons Authorized To Receive
It; Recordkeeping of Disclosures

EPA proposes to modify Secs. 2.301(h), 350.23(b)(3), and 2.209(g)
to streamline and clarify procedures for disclosure of CBI where
authorized to do so.
Section 2.301(h)(2)(iii) requires that before CBI may be disclosed
to an Agency contractor or subcontractor, advance notice must be given
to all affected businesses of the nature of the information to be
disclosed, the identity of the contractor or subcontractor, the
contract or subcontract number, and the purpose of the disclosure.
Affected businesses must be given at least 5 days to comment on the
proposed disclosure. Similarly, Sec. 2.301(h)(3)(ii) provides for
advance notice of disclosures to State and local governmental entities.
In addition, Sec. 2.301(h)(2)(iv) requires EPA offices disclosing
CBI to contractors to create a record of each disclosure, showing the
contractor or subcontractor, the contract or subcontract number, the
information disclosed, the date(s) of disclosure, and each affected
business; this record must be kept for at least three years. Similarly,
under Sec. 2.209(g), such a record must be kept with respect to
disclosures to Congress, a committee or subcommittee of Congress, the
Comptroller General, or another Federal agency. The following
paragraphs discuss proposed modifications to these requirements.

1. Form of Notice

Although neither Sec. 2.301(h)(2)(iii) nor Sec. 2.301(h)(3)(ii)
state the medium of the notice, the Agency's long-standing practice and
interpretation is that such notice may be given at least by letter or
Federal Register notice. EPA proposes to amend these paragraphs to make
explicit that notice in the Federal Register is one method of meeting
the requirements of these provisions.
EPA is also proposing to similarly amend Sec. 350.23(b)(3)
(governing EPCRA trade secret information), a provision equivalent to
Sec. 2.301(h).

2. Contract or Subcontract Number

Because Secs. 2.301(h)(2)(iii) and 350.23(b)(3) require that the
notice include the contract number, whenever EPA enters into a new
contract with the same contractor to do the same work as under a pre-
existing contract, a new Federal Register notice must be published (or
set of letters sent out), because the contract number has changed. EPA
believes the additional notice is a waste of Agency resources without
benefit to submitters, who already have notice of what information is
being provided to which contractor. Therefore, the Agency proposes to
eliminate the requirement to give notice of the contract or subcontract
number.

3. Response to Comments

Although a period for comments is provided by
Sec. 2.301(h)(2)(iii), the provision does not stipulate EPA's
responsibilities when comments are received. The Agency proposes to
revise the provision to make explicit the requirement to respond to
comments by affected businesses. EPA proposes to similarly revise
Sec. 350.23(b)(3) (governing disclosure of EPCRA trade secret data to
authorized representatives).

4. Records of Disclosures

Offices administering several environmental statutes (e.g., the
Toxic Substances Control Act (TSCA) and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)) have developed security manuals
requiring extensive document tracking activities. Those offices have
concluded that the sensitivity and volume of the business information
they handle require such procedures. However, EPA as a whole has not
determined that there is an Agency-wide need to track every piece of
paper it receives. The requirements of Secs. 2.209(g) and
2.301(h)(2)(iv) are most appropriate for a TSCA or FIFRA security
scheme, and are not necessary for the entire Agency, especially given
the good track record of the Agency, its contractors, and other Federal
agencies in handling CBI. Therefore, EPA proposes to delete
Secs. 2.209(g) and 2.301(h)(2)(iv); Agency offices would continue to
include such a requirement in their internal security procedures, where
appropriate.

O. Disclosure to Foreign Governments and International
Organizations

EPA proposes to amend Sec. 2.209 to provide for disclosure of CBI
to foreign governments and international organizations where authority
for such disclosure exists.
EPA may need to disclose confidential information to foreign
governments or international intergovernmental bodies, such as the
United Nations, e.g., to assist in law enforcement activities or
pursuant to statutory requirements (see, e.g., export regulations
implementing section 12(b) of the Toxic Substances Control Act at 40
CFR Part 707). 40 CFR 2.209, governing disclosures of CBI in general,
does not include a provision for disclosure to foreign governments or
international organizations, even though authority for such disclosure
might be found in treaties or other agreements entered into by the
United States.
EPA therefore proposes to include a provision in Sec. 2.209
allowing such disclosure where the Office of General Counsel finds that
there is authority for such disclosure. Disclosure to foreign
governments or international organizations would involve several
safeguards:
(1) A written request for disclosure would be required (unless EPA
made a written determination that such disclosure was necessary to
assist the Agency in carrying out one of its functions or to enable EPA
to assist the government or organization with a duly-authorized
function of that entity);
(2) The General Counsel would have to determine that the Agency has
authority for the disclosure requested;
(3) Disclosure must be pursuant to law and procedures which will
provide adequate protection to the interests of affected businesses;
and
(4) advance notice of disclosure would be provided to affected
businesses.
One exception to advance notice would exist: Notice would not be
provided of a disclosure in the course of a criminal or other law
enforcement investigation. EPA works in conjunction with other
governments and international law enforcement agencies, such as
INTERPOL, in an increasing number of transboundary environmental
investigations. The confidential exchange of information, without risk
of disclosure to possible subjects of the investigation, can be
essential in preventing an investigation from being compromised. To
ensure that disclosure to an international body without notice to the
submitter occurred only when necessary, the rule would require a
determination by the Director of the Office of Criminal Enforcement (in
the case of criminal investigations) or the Office of Regulatory
Enforcement or the appropriate Office of Regional Counsel (in the case
of civil investigations) that providing such notice would interfere
with a criminal or civil law enforcement investigation before
disclosure could be made without notice.

P. Safeguarding of Confidential Information by Enrollees Under the
Senior Environmental Employment (SEE) Program

EPA proposes to amend Sec. 2.211 to include SEE enrollees within
its coverage.
On February 5, 1993, EPA promulgated a rule (58 FR 7187),
authorizing disclosure of confidential data, submitted pursuant to
certain environmental statutes administered by the Agency, to persons
participating in the Senior Environmental Employment (SEE) Program.
This program is authorized by the Environmental Programs Assistance Act
of 1984 (Pub. L. 98-313), which provides that the Administrator may
``make grants or enter into cooperative agreements'' for the purpose of
``providing technical assistance to Federal, State, and local
environmental agencies for projects of pollution prevention, abatement,
and control.''
The rule treated grantees/cooperators under the SEE Program in the
same fashion as contractors, requiring that protective clauses be
inserted into the SEE grants and cooperative agreements.
However, the rule did not correspondingly amend 40 CFR 2.211, which
requires Federal employees, contractors, and contractor employees to
protect CBI (this requirement is in addition to that imposed by
contract and statute). EPA proposes to include SEE grantees and
enrollees within the ambit of Sec. 2.211.

Q. Disclosure to Federal Agencies for Law Enforcement Purposes

EPA proposes to amend Sec. 2.209(c) to provide that no notice is
required when the Agency discloses CBI to other Federal agencies for
law enforcement purposes.
Under 40 CFR 2.209(c), CBI may be disclosed to other Federal
agencies with advance notice to the submitter. The only existing
exception to the notice requirement is when the other agency is
performing a function on behalf of EPA, e.g., representation by the
Department of Justice. However, occasions may arise when EPA needs to
cooperate with other agencies on a law enforcement investigation, in
which the other agency would not be performing a function on behalf of
EPA, but would, primarily, be pursuing its own investigation. Examples
of such cases include the investigation of procurement fraud on
contracts with more than one Federal agency or the violations of
environmental laws by companies whose activities are under the
jurisdiction of more than one agency. In such cases, prematurely
notifying the submitter of the transfer of CBI might jeopardize the
investigation or discourage the other agency from cooperating with EPA.
Therefore, EPA is proposing to amend Sec. 2.209(c) to provide that
no notice need be given to affected businesses of disclosure of CBI to
another Federal agency in the course of a law enforcement
investigation.

R. Reconciliation of Program-Specific Confidentiality Provisions
With Part 2

EPA proposes to cross-reference part 2 to specific confidentiality
provisions currently contained in specific program regulations outside
of part 2.
40 CFR part 2, subpart B regulates treatment of confidential data
by the Agency, and includes special provisions for each major
environmental statute administered by EPA. However, many program-
specific regulations outside of part 2 (e.g., Clean Air Act regulations
in 40 CFR parts 57, 85 and 86, and Toxic Substances Control Act
regulations in parts 710 and 720) contain confidentiality provisions
which, in some cases, differ from those of part 2.
EPA has always considered the program specific confidentiality
regulations as supplemental to part 2. However, the lack of reference
to such regulations in part 2 can be confusing both for the Agency and
for persons attempting to understand and comply with EPA's
confidentiality regulations. In determining how to resolve such
confusion, the Agency had to deal with competing considerations. First,
the Agency should be as consistent as possible in its treatment of CBI.
On the other hand, each program within the Agency is working with a
different statute (with slightly or significantly varying
confidentiality provisions) and operates in a different milieu of data,
confidentiality claims, and public interest in the information.
EPA is proposing to cross-reference existing program specific
confidentiality regulations in part 2 (the original provisions would
also remain in their respective parts). In some cases, minor changes
would be made to the program specific regulations where tighter
conformance with part 2, subpart A general regulations is desirable.
These changes are discussed on a statute-specific basis below.
The proposed reconciliation of program-specific CBI provisions with
part 2 does not affect 40 CFR part 350, governing trade secrecy under
the Emergency Planning and Community Right-to Know Act of 1986.

S. Changes to Rules Governing Certain Information Obtained Under the
Clean Air Act

1. Applicability of 40 CFR 2.301, Special Rules for the Clean Air Act

EPA proposes to amend Sec. 2.301(b)(1)(ii) to comport with the
language of section 208(a) of the Clean Air Act, as amended in 1990. In
particular, the Clean Air Act Amendments expanded EPA's authority under
section 208(a) to obtain information ``to otherwise carry out the
provision of (part A) and part C'' of the Clean Air Act. Also, the
language makes clear that EPA's authority under section 208(a) relates
specifically to part A and part C of Subchapter II of the Clean Air
Act.

2. Basic Rules Which Apply Without Change and Assertion of Claims

Section 2.203(c) allows businesses as a general matter to assert
late confidentiality claims. Specific Clean Air Act regulations in
parts 57 and 85 of Title 40 differ by providing that confidentiality
claims must accompany the information at the time it is submitted to
EPA. In addition, certain Clean Air Act regulations require that a
sanitized version of the information must be provided and that CBI
claims must be indicated by bracketing, stamping, or otherwise
specifying the claimed information in order to assert that information
submitted is confidential. Finally, in 40 CFR 85.408, EPA's motor
vehicle regulations additionally require specific labelling and
numbering of documents claimed confidential. EPA is proposing changes
here to Sec. 2.301 (c) and (d) to incorporate these specific Clean Air
Act requirements into part 2.

3. Changes to Specific Clean Air Act Regulations Under Parts 57, 85 and
86

EPA is proposing additional minor changes to Clean Air Act
regulations to reconcile those regulations with the changes being
proposed for part 2. Specifically, EPA is proposing to amend references
to Sec. 2.204(c)(2)(i)(A). That provision currently specifies that in
certain cases where a submitter might have been expected to assert a
confidentiality claim but did not, the EPA office shall contact the
business to inquire whether the business asserts a claim covering the
information. Since EPA is proposing that this inquiry provision be
deleted (prospectively only, see section B., above), references to the
provision in Clean Air Act regulations should apply only to data
submitted before the date the change to Sec. 2.204(c)(2)(i)(A) becomes
final. Also, the provisions currently contain references to Federal
Register notices publishing outdated versions of part 2 rules; EPA
would delete these references.

4. Substantive Criteria for Confidentiality Determinations: Production
and Consumption Allowances Under Title VI

Section 602 of the Clean Air Act provides for additions to the
lists of class I and class II ozone depleting substances. Section 607
specifies that the Administrator shall promulgate regulations providing
for production and consumption allowances of these substances. As
explained in detail below, the Act without exception compels the public
disclosure of companies' production and consumption allowances for such
newly listed substances; such disclosure is likely to result in the
release of information otherwise regarded as confidential. Congress
specified that the allowances are to be based on companies' individual
production and consumption levels. Therefore, upon promulgation of a
final rule listing a new ozone depleting substance as a class I
substance, the Agency believes that this information should not be
entitled to treatment as CBI. This is consistent with the position the
Agency has taken in an information collection request for information
regarding production and consumption of methyl bromide. 58 FR 15014
(March 18, 1993).
It is unnecessary to treat information as CBI or to undertake
regulatory procedures to disclose CBI where the statute directly
requires that specific information be disclosed. As explained below,
the Clean Air Act compels the Agency to disclose specific information
related to the establishment of limits on ozone-depleting substances.
Therefore, the Agency believes that this information is not eligible
for confidential treatment.
The relevant provisions of Titles III and VI of the Clean Air Act
require the Agency to disclose company- and chemical-specific
production and consumption allowances for a newly listed substance, at
least where the company produces or consumes only one such newly listed
substance. Sections 604 and 607 together require that EPA issue
company- and chemical-specific allowances for production and
consumption of newly listed substances. Section 604 imposes production
and consumption limits on each company based on the company's baseline
year production and consumption of the newly listed substance. A
company is limited to a specified percentage of its baseline year
production and consumption of the particular chemical. Section 607
requires EPA to ``promulgate rules * * * providing for the issuance of
allowances'' for the production and consumption of listed substances.
Under this provision, EPA is to issue specific allowances in accordance
with production and consumption limits. Particularly where allowances
are issued for a single newly listed substance, disclosure of a
company's allowances based on baseline year production and consumption
levels would disclose what might ordinarily be considered CBI.
Congress enacted sections 604 and 607 against the regulatory
backdrop of EPA's regulations implementing the Montreal Protocol under
existing Clean Air Act authority (former section 151(b)). The Agency
implemented the Protocol production and consumption limits through
rulemaking establishing company-specific allowances. See 53 FR 30566
(August 12, 1988) (implementing the Montreal Protocol and allotting
production and consumption allowances to producers and importers). The
adoption of sections 604 and 607 in the 1990 Amendments indicates that
Congress intended to continue the Agency's company-specific approach.
Section 604 requires that production and consumption limits apply on a
company-specific basis. Section 607 requires that allowances be based
on these company-specific limits. The Agency's current regulations
under section 607 comport with this approach. See 56 FR 9518 (March 6,
1991) (temporary final rule implementing 1991 production and
consumption limits under section 604); 56 FR 49548 (Sept. 30, 1991)
(Notice of Proposed Rulemaking to implement 1992 and later production
and consumption limits under section 604). Title VI calls for issuance
of company- and chemical-specific allowances for listed substances.
Further, under section 307(d)(1), of the Clean Air Act, the public
participation and disclosure provisions of section 307(d) apply to
``promulgation or revision of regulations under Title VI.'' Therefore,
the allowances must be published for public comment to be legally
binding and enforceable. In addition, under section 307(d)(3), the
Agency is obligated to include the factual basis for the allowances in
the docket for the rulemaking and to include a summary of the factual
data in the statement of basis and purpose for the proposed and final
rule.
The Clean Air Act's citizen suit provision further confirms that
Congress intended Title VI production and consumption limits be
disclosed to the public. Section 304 authorizes ``any person'' to
commence a civil action alleging a violation of an emission standard or
limitation under the Act. Section 304(f) defines ``emission standard or
limitation under this Act'' to include, inter alia, ``a schedule or
timetable of compliance, emission limitation, standard of performance
or emission standard,'' and thus includes title VI production and
consumption limits. Public disclosure of company- and chemical-specific
production and consumption limits is necessary for citizens to
challenge violations of those limits.
Therefore, EPA proposes to amend Sec. 2.301(e) to provide that
production and consumption allowance information is not entitled to
confidential treatment.

5. Confidentiality of Certain Emission Data

EPA is proposing a new Sec. 2.301(e)(2) to specifically identify
emission data that are not entitled to confidential treatment and,
notwithstanding a confidentiality claim, may be disclosed without
further notice. This proposal would codify current EPA policy regarding
categories of data that may be excluded from the trade secret
definition. That policy was published at 56 FR 7042 (February 21,
1991). As EPA explained in that notice, EPA believes that some kinds of
data will always constitute emission data within the meaning of section
114(c) of the Act. The list of types of data specified here is not
intended to be a comprehensive list of those types of data which are
not entitled to confidential treatment, but is intended to facilitate
the use of these data without the need for further processing of
confidentiality claims. EPA believes that the information identified is
sufficiently specific that a case-by-case evaluation of whether data
submitted is covered by the new Sec. 2.301(e)(2) is not necessary.

6. Confidentiality of Gasoline Performance Baselines

On December 15, 1993, EPA issued final regulations for the Clean
Air Act's reformulated and conventional gasoline programs. This rule
was published on February 16, 1994 (59 FR 7716). The regulations
require that refiners and importers of gasoline submit certain
information to EPA concerning the quality of the gasoline they produced
or imported in 1990. From this, EPA establishes an individual baseline
for the refinery or importer. In large part, the individual baseline
then becomes the refiner's or importer's performance standard for
conventional gasoline. In effect, the quality of their gasoline must on
average meet or exceed specified standards set at their 1990 individual
baseline levels. A similar approach is used in the reformulated
gasoline program for certain standards, however, these standards only
apply to certain fuel parameters and only apply for the first three
years of that program.
The regulations concerning individual baselines include two
provisions relating to public disclosure of this information. First,
under 40 CFR 80.93(b)(6)(i) EPA will publish the individual standards
for each refinery and importer, including baseline emissions. In
addition, under 40 CFR 80.93(b)(6)(ii) EPA determined that certain
information provided by the refiner or importer in their individual
baseline submission would not be considered confidential, under the
theory that such information constitutes emission data.
Various interested parties have since sought judicial review of
these individual baseline regulations, including those provisions
governing confidentiality. In light of this litigation, and to avoid
confusion, EPA is not proposing today to cross reference these
individual baseline regulations in Sec. 2.301, but instead will
determine the appropriate revision to part 2 at a later time. In the
meantime, the confidentiality provisions in 40 CFR 80.93(b)(6) remain
in effect.

T. Changes to Rules Governing Certain Information Obtained Under the
Clean Water Act

The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.302 and to certain other regulations in Title 40
which relate to the handling of CBI under the Clean Water Act (CWA).
These changes are intended to make CWA confidentiality provisions
published in 40 CFR parts 122, 123, 233, 403 and 501 consistent with
the provisions, including the changes proposed today, in 40 CFR part 2.

1. Substantive Criteria for Use in Confidentiality Determinations

The Agency is proposing to amend the part 2 supplemental CWA
provision (Sec. 2.302) to incorporate, for purposes of consistency,
certain limitations on confidentiality currently provided by the CWA
regulatory provisions (Secs. 122.7, 233.3, and 501.15). These sections
provide that: (1) Effluent data, (2) the name and address of any permit
applicant or permittee, and (3) any permit application (including any
attachments used to supply information required by the application
forms) or permit are not eligible for confidential treatment. This
change to Sec. 2.302 would not substantively alter the Agency's
approach to CBI under the CWA.

2. Changes to Specific Clean Water Act Regulations

Under Parts 122, 123, 233 and 403
As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Secs. 122.7, 123.41 and 403.14 of this part to
make those sections consistent with part 2 procedures, including
changes proposed today. Specifically, the Agency is proposing to amend
these sections to clarify that submitters are not prohibited from
asserting CBI claims subsequent to the time of submission, but that any
such late claims will be treated in accordance with Sec. 2.203.
Sections 122.7, 123.41 and 403.14 would continue to refer to the part 2
regulations as controlling the handling of CBI.
The Agency is proposing to amend Sec. 233.3, which relates to
confidentiality of information under the Section 404 State Program
Regulations (part 233). In its current form, Sec. 233.3 states that
information submitted under part 233 may be claimed as confidential and
that ``a final determination as to that claim will be made in
accordance with the procedures of 40 CFR part 2.'' This language could
be interpreted to mean that the Agency will make a final CBI
determination for all information submitted under part 233 for which a
CBI claim is asserted. Such an interpretation would be inconsistent
with both Agency practice and the procedures set forth in part 2. Part
2 does not require a CBI determination every time a CBI claim is
submitted. Rather, information so submitted is protected as CBI until
such time as the Agency has a need to disclose such information (for
example, when the information is needed as part of a proceeding, or
when responding to a Freedom of Information Act Request). Therefore,
the Agency proposes to amend Sec. 233.4 to conform with standard Agency
CBI procedures, as set forth in part 2.
Finally, the Agency proposes to amend the discussion in Sec. 123.42
concerning disclosure of CBI to States to include a reference to the
part 2 confidentiality regulations. This change would clarify that
disclosures of information under that section are subject to part 2.

U. Changes to Rules Governing Certain Information Obtained Under the
Safe Drinking Water Act

The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.304 and to certain regulations in 40 CFR part 145
which relate to the handling of CBI under the Safe Drinking Water Act
(SDWA). These changes are intended to make parts 144, 145 and 147
confidentiality provisions consistent with the provisions, including
the changes proposed today, in 40 CFR part 2.

1. Substantive Criteria Used in Confidentiality Determinations

The Agency is proposing to amend the part 2 supplemental SDWA
provision (Sec. 2.304) to incorporate, for purposes of consistency,
certain limitations on confidentiality currently provided by the SDWA
regulatory provisions (Secs. 144.5 and 147.2907). These sections
provide that neither (1) the name and address of any permit applicant
or permittee nor (2) information which deals with the existence,
absence, or level of contaminants in drinking water are eligible for
confidential treatment. This change to Sec. 2.304(e) would not
substantively alter the Agency's approach to CBI under the SDWA.

2. Changes to Specific Safe Drinking Water Act Regulations Under Part
145

As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Sec. 145.14 of this part to make that section
consistent with part 2 procedures, including those changes proposed
today. Specifically, the Agency is proposing to amend Sec. 145.14 to
clarify that submitters are not prohibited from asserting CBI claims
subsequent to the time of submission, but that any such late claims
will be treated in accordance with Sec. 2.203. Section 145.14 would
continue to refer to the part 2 regulations as controlling the handling
of CBI.

V. Changes to Rules Governing Certain Information Obtained Under the
Solid Waste Disposal Act

The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.305 and to certain regulations in 40 CFR parts
270, 271 and 281 which relate to the handling of CBI under the Solid
Waste Disposal Act, as amended by the Resource Conservation and
Recovery Act (RCRA). These changes are intended to make all RCRA
confidentiality provisions consistent with the provisions, including
the changes proposed today, in 40 CFR part 2.

1. Disclosure of Hazardous Waste Export Information

40 CFR 260.2 and 262.53 provide that certain information submitted
in notifications of intent to export a hazardous waste will be provided
to the Department of State and the appropriate authorities in a
receiving country, regardless of any claims of confidentiality.
Consistent with the Agency's intent to integrate the part 2
supplemental CBI regulations with regulations relating to CBI found
under other Agency program regulations, EPA is proposing to amend the
supplemental RCRA CBI regulation at Sec. 2.305 to include, as a new
paragraph Sec. 2.305(f), this already existing limitation on
confidentiality treatment.

2. Changes to Specific Resource Conservation and Recovery Act
Regulations Under Parts 270, 271, and 281

As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Secs. 270.12, 271.17, 271.132 and 281.43 to
make those sections consistent with part 2 procedures, including the
changes proposed today. Specifically, the Agency is proposing to amend
these sections to clarify that submitters are not prohibited from
asserting CBI claims subsequent to the time of submission, but that any
such late claims will be treated in accordance with Sec. 2.203. These
sections would continue to refer to the part 2 regulations as
controlling the handling of CBI.

3. Change to List of Authorities

In the authority section for part 2 and in Sec. 2.305, section 9005
of RCRA is incorrectly cited as 42 U.S.C. 6995. The citation will be
corrected to 42 U.S.C. 6991d.

W. Changes to Rules Governing Certain Information Obtained Under the
Toxic Substances Control Act

The Agency is proposing amendments to its supplemental CBI
regulations at Sec. 2.306 which relate to the handling of CBI under the
Toxic Substances Control Act (TSCA). These changes are intended to make
all TSCA confidentiality provisions consistent with the provisions,
including the changes proposed today, in 40 CFR part 2, and to clarify
the scope of health and safety data under TSCA.

1. Signature of a Senior Management Official for Some Confidentiality
Claims and Substantiations

EPA proposes to make several amendments to require that a senior
management official sign all assertions and substantiations of
confidentiality claims for information submitted pursuant to the
following provisions, which constitute the core TSCA program: 40 CFR
part 704, subpart A (Reporting and Recordkeeping Requirements--General
Reporting and Recordkeeping Provisions for Section 8(a) Information-
Gathering Rules); 40 CFR part 704, subpart C (Reporting and
Recordkeeping Requirements--CAIR: Comprehensive Assessment Information
Rule--General Reporting and Recordkeeping Provisions); 40 CFR part 707,
subpart D (Chemical Imports and Exports--Notices of Export Under
Section 12(b)); 40 CFR part 710, subpart A (Inventory Reporting
Regulations--Compilation of the Inventory); 40 CFR part 710, subpart B
(Inventory Reporting Regulations--Partial Updating of the Inventory
Data Base); 40 CFR part 712 (Chemical Information Rules); 40 CFR part
716 (Health and Safety Data Reporting); 40 CFR part 717 (Records and
Reports of Allegations that Chemical Substances Cause Significant
Adverse Reactions to Health or the Environment); 40 CFR part 720
(Premanufacture Notification); 40 CFR part 723, subpart B
(Premanufacture Notice Exemptions--Specific Exemptions); 40 CFR part
750, subpart B (Procedures for Rulemaking Under Section 6 of the Toxic
Substances Control Act--Interim Procedural Rules for Manufacturing
Exemptions); 40 CFR part 750, subpart C (Procedures for Rulemaking
Under Section 6 of the Toxic Substances Control Act--Interim Procedural
Rules for Processing and Distribution in Commerce Exemptions) ; and 40
CFR part 790, subpart A (Procedures Governing Testing Consent
Agreements and Test Rules--General Provisions).
First, EPA proposes to amend Sec. 2.306(a) to include a definition
of ``senior management official''. Second, EPA proposes to amend
Sec. 2.306(d) and the applicable portions of the TSCA implementing
rules to require that assertions and substantiations of confidentiality
in the core TSCA program be signed by such a senior management
official.
The definition of senior management official is taken nearly
verbatim from the implementing regulations of the Emergency Response
and Community Right-To-Know Act (EPCRA), 42 U.S.C. 11001 et seq., at 40
CFR 350.1. As incorporated, this definition of senior management
official has been codified since 1988 and is well understood.
Submitters of information pursuant to EPCRA have made the determination
of who a senior management official is. Most submitters of information
pursuant to TSCA also submit information pursuant to EPCRA. The choice
to use very similar language was made to simplify reporting burdens for
submitters by imposing very similar reporting requirements. This will
also have the effect of providing consistency between the TSCA and
EPCRA programs administered by EPA which will become more important as
the Agency seeks to enhance the compatibility of its data bases.
EPA believes that one situation in which submitters assert
unsupportable confidentiality claims occurs when there is an inadequate
review of claims at the corporate level. Individual staff and less
senior management officials often lack the organizational perspective
to view confidentiality claims in the context of an entire corporate
policy and are unaware of the actions of other business units regarding
confidentiality claims.
Based on a limited sampling of submissions pursuant to TSCA, it
appears that a majority of TSCA submissions containing confidentiality
claims already conform with a senior management signatures requirement.
EPA believes that this wide-spread industry practice provides for
needed management oversight and seeks, by this rule, to
institutionalize the practice.
EPA believes that requiring all confidentiality claims and
substantiations for submissions subject to this requirement to be
signed by a senior management official is the most effective way to
ensure that sufficient deliberation and consideration is made when
claiming confidential status. As discussed in section W.3, below, EPA
seeks to increase the amount of accurate TSCA derived chemical
information available to the public. The Agency believes that
prescribing a senior level of scrutiny will help alleviate
unsupportable confidentiality claims. Also, EPA treats information
claimed confidential very carefully at significant cost and expects the
cooperation of industry to assure that such costs are incurred only
where necessary.
Authority for a senior management official signature requirement
exists in Sec. 14(c) of the Act which states that ``[a] designation * *
* shall be made in writing and in such a manner as the Administrator
may prescribe''. This authority to impose a similar signature
requirement has been previously exercised. See, e.g., 40 CFR
710.32(c)(2).

2. Up-front Substantiation of Confidentiality Claims for Chemical
Identity

EPA proposes to amend Secs. 2.306(d), 716.55 and 717.19 to require
that claims of confidentiality for chemical identity in Records and
Reports of Allegations that Chemical Substances Cause Significant
Adverse Reactions to Health or the Environment, submitted pursuant to
section 8(c) of TSCA, Health and Safety Data Reports, submitted
pursuant to section 8(d), and notices of substantial risk, submitted
pursuant to section 8(e), must be accompanied by a substantiation at
the time of submission. This requirement will apply only to chemicals
listed on either the public or confidential portions of the TSCA
Chemical Inventory. Chemicals not on the inventory, i.e., those not
available in commerce, will not be subject to this requirement.
EPA would prospectively require submitters to substantiate the
confidentiality claims described above at the time of filing by
responding to a series of questions. These substantiation questions are
designed to address with particularity the issues generally framed by
Secs. 2.204(e)(4) and 2.208 which set forth, among other factors, the
criteria of:
(1) What portion of the information the submitter believes is
entitled to confidential treatment;
(2) The length of time for which confidential treatment is desired;
(3) Measures taken by the business to prevent undesired disclosure
to others;
(4) The extent to which the information has already been disclosed
to others; and
(5) Why release of the information would result in substantial
harmful effects to the business' competitive position in the
marketplace. 40 CFR 2.204(e)(4).
EPA has, for several years, consistently reviewed confidentiality
claims for chemical identity asserted in submissions pursuant to
sections 8(d) and 8(e) of TSCA. This heightened scrutiny has occurred
contemporaneously with a decision by EPA's Office of Pollution
Prevention and Toxics to increase the amount of accurate TSCA-derived
chemical information available to the public. The major focus of these
dissemination activities has been on making available health and safety
data.
EPA considers chemical identity to be part of, or underlying data
to, a health and safety study in health and safety data reports. See,
40 CFR 716.3. Furthermore, this definition of health and safety data
will be formalized for all TSCA submissions (See the revision to
Sec. 2.306(a)(3) and accompanying preamble discussion, infra). As a
result, claims of confidentiality for chemical identity in such filings
are considered carefully. Nevertheless, there are situations where
chemical identity in a health and safety study may be entitled to
confidentiality.
Any inquiry into a confidentiality claim is a fact-specific
exercise. In this particular circumstance, EPA has determined that
there is a data gap when reviewing confidentiality claims for chemical
identity in health and safety studies. Necessary facts regarding
competitive market forces, the nature of the potential harm perceived
by the submitter, the submitter's treatment of the information and
other vital factors are not available to properly evaluate the claim.
This requires the Agency to contact by telephone the submitter each
time a claim is considered. Often, it is necessary to follow up the
telephone call with a written substantiation request pursuant to 40 CFR
2.204(d)(1).
There are, however, significant problems with the current practice.
First, it is inefficient for submitters. A submitter must carefully
consider a confidentiality claim prior to asserting it to the Agency.
The questions and issues so considered are substantially similar to the
questions a submitter must answer and the issues a submitter must
consider when responding to a substantiation request pursuant to 40 CFR
2.204(d)(1). When responding to such a substantiation request, the
submitter is simply considering for a second time and recording the
same thought processes as before. By requiring the submitter to take
one look at the issues implicated by a confidentiality claim, and
eliminating the duplicative two-step consideration process for
submitters, the up-front substantiation requirement will be less
burdensome on submitters.
Second, the current process lacks rigor, and is time-inefficient
for EPA. Decisions are sometimes based on insufficient information or
resources are expended gathering data which would be collected by the
up-front substantiation requirement. Through imposing this new
requirement, EPA seeks to improve the quality and speed of
decisionmaking on confidentiality claims for chemical identity.
At the same time, EPA wishes to minimize the burden placed on
submitters by the imposition of this new requirement. For this reason,
the Agency has decided to impose an up-front substantiation requirement
only for chemicals listed on the TSCA Chemical Inventory.
The rationale for this limitation is as follows. The intended
result of the confidentiality claim review process is to make more and
more useful chemical information available to the public. Chemicals
which are not listed on the TSCA Chemical Inventory may not legally
enter commerce, except in extraordinarily limited circumstances. There
is a lesser risk of exposure, and therefore, a lesser utility for
chemical information for public information purposes, if a chemical
substance is not available in commerce.
The implementation of an up-front substantiation requirement for
confidentiality claims for chemical identity in the limited
circumstances above is carefully sculpted to address the information
needs of the Agency while minimizing the burden placed on industry.
Authority for an up-front substantiation requirement exists in the
Freedom of Information Act, the Trade Secrets Act, and section 14(c) of
TSCA, which states that ``[a] designation * * * shall be made in
writing and in such a manner as the Administrator may prescribe''. (cf.
discussion of sunset provisions in section F., above). This authority
to impose an up-front substantiation requirement has been exercised
numerous times in the past, including for confidentiality claims for
chemical identity. See, e.g., 40 CFR 710.38(c)(1); 40 CFR
720.85(b)(3)(iv).

3. Definition of Health and Safety Data

EPA is proposing to clarify the definition of ``health and safety
data'' in Sec. 2.306(a)(3) (the term ``health and safety data'' would
be used interchangeably with ``health and safety study'') by adding
additional language to the definition to indicate that the term
encompasses not only data from a formal study but also any data
pertaining to the effects of a chemical on health or the environment.
The language is taken directly from the definition of ``health and
safety study'' in 40 CFR 716.3(e), which implements health and safety
data reporting pursuant to TSCA section 8(d), and in 40 CFR 720.3(k),
which implements premanufacture notification procedures pursuant to
TSCA section 5. EPA would include this clarification to ensure
regulatory consistency under TSCA.

4. Disclosure of Health and Safety Data

TSCA section 14(b) provides that data from health and safety
studies are not eligible for confidential protection unless disclosure
of such data would further disclose process information or proportions
of a mixture. As a means of implementing section 14(b),
Sec. 2.306(a)(3) currently defines health and safety data to exclude
data whose disclosure would further disclose process information or
proportions of a mixture. This definition achieves the result intended
by TSCA section 14(b), that process and mixture information are not
automatically exempt from confidential treatment.
However, Sec. 2.306(a)(3) as currently written does not properly
reflect the structure imposed by section 14(b). Therefore, EPA is
proposing to: (1) Modify Sec. 2.306(a)(3) to indicate that information
pertaining to process and mixture data may still be health and safety
data, and (2) revise Sec. 2.306(g) (criteria for confidential
treatment, redesignated in this proposal as Sec. 2.306(h) for reasons
unrelated to the discussion here) such that health and safety data
whose disclosure would further disclose process information or
proportions of a mixture may be eligible for confidential treatment if
they meet the standard criteria for confidentiality articulated in
Sec. 2.208. No substantive change in the eligibility of such data for
confidentiality is intended.

5. Reconciliation of TSCA Program-Specific Rules With Part 2 Rules

EPA proposes to incorporate various confidentiality provisions in
the TSCA implementing regulations (subchapter R of title 40) into part
2. Subchapter R contains several program specific confidentiality rules
tailored to the individual needs of the program. This amendment will
clarify the provisions that apply to information submitted pursuant to
TSCA.
Section 2.306(c) currently provides that Sec. 2.203 of the part 2
basic rules (the basic rules are those which apply over all programs,
except where otherwise indicated) applies without change to information
covered by Sec. 2.306. Section 2.203 governs procedures for asserting
claims of confidentiality. Because (1) subchapter R rules which contain
provisions governing confidentiality would be incorporated into
Sec. 2.306, and (2) many of these provisions differ from those in
Sec. 2.203, EPA would include a new paragraph, Sec. 2.306(d), detailing
the extent to which Sec. 2.203 and subchapter R provisions govern
assertion of CBI claims.
Similarly, those subchapter R provisions pertaining to disclosure
of CBI in special circumstances (normally governed by Sec. 2.209) would
be incorporated into Sec. 2.306(i) (currently Sec. 2.306(h)). Section
2.306(i) would also incorporate provisions for disclosure of
confidential chemical identities to bona fide requestors under 40 CFR
parts 710, 720, 721, and 723, and for disclosure to foreign governments
of export information under Sec. 707.75(c).
Current provisions under the Pre-manufacture Notification (PMN) and
Polymer Exemption Rules require reassertion and substantiation of a CBI
claim for chemical identity upon filing of a Notice of Commencement
(NOC). The rules also provide for expiration of the chemical identity
CBI claims for the underlying PMN and Polymer Exemption Application
should the NOC be filed without such reassertion and substantiation.
These provisions would be incorporated into a new paragraph
Sec. 2.306(m), a sunset provision consistent with proposed Sec. 2.216.

6. Sunset Provisions

EPA has considered proposing a sunset provision (see section F.,
above) for all confidentiality claims for information collected
pursuant to TSCA, or for some discrete subset of claims. At this time,
the Agency has decided to defer proposal of a TSCA sunset provision.
EPA believes that a sunset provision is appropriate only with respect
to those data collections where there is an identified need for
information to be publicly available after the passage of time (or
occurrence of an event). The Agency may reconsider TSCA sunset
provisions after appropriate analysis and articulation of need.
In order to evaluate the issues identified above, EPA solicits
comments on the following with respect to TSCA sunset provisions:
A. What information collected pursuant to TSCA would be most
appropriate for application of a sunset provision? Should the sunset
provision apply to all TSCA submissions of a specified type of
information (e.g., all submitter identities) or only with respect to
individual data collections (e.g., all submitter identities in
submissions pursuant to the Partial Updating of the Inventory Data
Base, 40 CFR 710.23 et seq.)? What information collected pursuant to
TSCA would be least appropriate for application of a sunset provision?
B. How long should the period be before sunset occurs?
C. Are any mechanisms in place for industry to periodically review
and relinquish confidentiality claims whose rationales for assertion
have disappeared? If so, is there any vehicle for the dissemination of
information no longer claimed as confidential?

X. Changes to Rules Governing Certain Information Obtained Under the
Federal Insecticide, Fungicide, and Rodenticide Act

The Agency is proposing amendments to its supplemental CBI
regulations at Sec. 2.307 which relate to the handling of CBI under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These
changes are intended to: (1) Make all FIFRA confidentiality provisions
consistent with the provisions, including the changes proposed today,
in 40 CFR part 2;
(2) Codify procedures regarding handling of FIFRA CBI previously
announced in Federal Register notices; and
(3) Clarify procedures for release of FIFRA CBI in emergency
situations.

1. Codification of 1978 Interim Procedures

In 1978, Congress amended FIFRA to include new provisions for the
treatment and release of CBI. On December 19, 1978, EPA published in
the Federal Register a Notice of Interim Procedures for the treatment
of such information (43 FR 59060). At that time, EPA stated that the
interim procedures would remain in effect pending issuance of
amendments to the Agency's regulations at 40 CFR part 2. EPA is
proposing to amend the part 2 regulations applicable to information
submitted under FIFRA to incorporate the 1978 interim procedures as
permanent procedures. For more information on the rationale behind
specific provisions, please refer to the Notice of Interim Procedures
at 43 FR 59060.
Specifically, this proposed rule would establish procedures for
handling FIFRA CBI under the following circumstances:
a. Disclosure of CBI relating to formulas of products in public
hearings and in findings of fact issued by the Administrator.
The term ``findings of fact'' includes, but is not limited to, the
process of reviewing pesticides in order to decide whether to register,
reregister, or cancel those products, particularly notices published
during the Special Review process under 40 CFR part 154 (formerly known
as the RPAR or ``rebuttable presumption against registration''
process). The term also applies in cases where an inert ingredient of a
pesticide is the subject of a Special Review notice.
b. Disclosure of test data relating to registered or previously
registered pesticides pursuant to FIFRA.
The proposed Sec. 2.307(g) would clarify that, pursuant to FIFRA
section 10(d)(1), where safety and efficacy data (defined in proposed
Sec. 2.307(a)(5)) are submitted with regard to ``a registered or
previously registered pesticide or its separate ingredients,
impurities, or degradation products'' (language from FIFRA section
10(d)(1)), EPA will deny any claim of confidentiality for that data
unless the submitter can show that it would disclose one or more of the
three types of information specifically protected by FIFRA section
(10)(d)(1) (A)-(C), relating to manufacturing and quality control
processes, the identity and quantity of inert ingredients, and methods
of testing, detecting or measuring the quantities of inert ingredients.
Where data are submitted with regard to a pesticide which is not yet
registered, EPA will continue to follow the general procedures for
determining confidentiality of information under the general part 2,
subpart B rules. Section 2.307(a)(5) would also embody EPA's
interpretation that the language in section 10(d)(1) concerning ``a
registered or previously registered pesticide'' means that data
pertaining to pesticides which have never been registered (i.e., data
from applicants) is not subject to mandatory section 10(d)(1)
disclosure.
c. Disclosure of FIFRA CBI to contractors.
The 1978 Notice of Interim Procedures stated that the Office of
Pesticide Programs (OPP) and its contractors would follow the security
procedures listed in the EPA TSCA Confidential Business Information
Security Manual pending development of procedures specific to the
pesticides program. Since then OPP has completed its FIFRA Information
Security Manual. This document contains the procedures EPA and its
contractors follow when handling FIFRA CBI and is available through the
Information Services Branch of OPP. Therefore, EPA proposes that
Sec. 2.307(h)(3)(v) state that contractors who are allowed access to
FIFRA CBI will be required to follow the security procedures detailed
in that manual.
d. Disclosure of data to foreign or multinational pesticide
producers.
The 1978 amendments to FIFRA included a provision, section 10(g),
which prohibits EPA from providing data submitted by a registrant or an
applicant for registration (without the submitter's consent) to any
employee or agent of any business or other entity engaged in the
production, sale, or distribution of pesticides in countries other than
the United States or in addition to the United States, or to any other
person who intends to deliver such data to any such foreign or
multinational entity. In addition, FIFRA section 10(g) compels the
Administrator to require that every person requesting data affirm that
such person does not seek access to the data in order to deliver it or
offer it for sale to any foreign or multinational entity described
above, and that such person will not purposefully deliver it nor
negligently cause it to be delivered to any such entity. This proposed
rule would codify the procedures by which EPA implements this section
and the affirmation which must be made by all persons seeking access to
data submitted by registrants or applicants under FIFRA.
The text of FIFRA section 10(g) uses the terms ``information'' and
``data'' interchangeably. EPA has historically interpreted this section
to apply only to test data submitted by registrants and applicants for
registration. This is because section 10(g) was designed to prevent
companies from obtaining proprietary data from EPA under FOIA and FIFRA
section 10(d)(1) and using it to gain market entry in foreign countries
without contributing to the costs of developing the data, as FIFRA
section 3(c)(1)(F) requires of domestic market entrants. The term
``information'' could be read to include items which EPA routinely
makes available such as registration applications, product labeling,
and general offers to pay data compensation. Because EPA believes that
Congress intended to restrict foreign companies' access to registration
data, EPA interprets section 10(g) to apply only to test data.
On September 24, 1985, EPA issued Class Determination 3-85, stating
that reviews of data submitted by applicants or registrants which were
prepared by EPA personnel or under an EPA-funded contract and which do
not reveal the full methodology and complete results of the study,
test, or experiment, and all explanatory information necessary to
understand the methodology or interpret the results are not subject to
FIFRA section 10(g). Class Determination 3-85 noted that section 10(g)
``is intended to prevent a person from obtaining, under FIFRA, data
generated at another person's expense and then using the data to obtain
the approval of another country's government to manufacture, sell, or
use pesticides in that country * * * Disclosure of EPA reviews of data
(provided that they are truly reviews, and not essentially complete
reports) will not be useful in obtaining approvals by governments of
other countries. To the extent that such a country requires data to
evaluate the request, it is unlikely to be satisfied with a review of
data conducted by EPA; to the extent that such a country is willing to
accept an EPA review in lieu of data, it is just as likely to accept
other readily available information indicating EPA's position, such as
evidence that EPA has registered the product.'' EPA proposes to codify
this interpretation of FIFRA section 10(g) in Sec. 2.307(i)(1).
Class Determination 3-85 also stated that reviews of safety and
efficacy data which contain neither the three types of information
specifically protected by FIFRA section (10)(d)(1) (A)-(C) nor
unpublished information concerning the production, distribution, sale,
or inventories of a pesticide are not eligible for confidential
treatment. This would be codified in proposed Sec. 2.307(k)(2).

2. Incorporation of FIFRA Program Provisions Regarding CBI

In addition to the procedures proposed above, EPA is proposing to
amend the part 2 regulations to reference various regulations
promulgated under FIFRA at 40 CFR parts 152, 154, 155, and 158, which
contain specific provisions regarding CBI submitted under those
regulations. This amendment would not change the substance of those
provisions, but would merely incorporate them into Sec. 2.307. These
provisions pertain mainly to assertion of business confidentiality
claims when submitting particular types of information; also
incorporated (in Sec. 2.307(k)(1)) is a provision currently in
Sec. 152.119(b), governing public inspection of materials submitted to
comply with section 3(c)(1)(D) of FIFRA.
In addition, the Agency is proposing to add a new paragraph
Sec. 2.307(j), regarding designation by a business of an addressee for
notices and inquiries. This provision would incorporate the
requirements of 40 CFR 152.50(b) (2) and (3) for businesses which are
registrants or applicants for registration of a pesticide. For parties
other than registrants or applicants, Sec. 2.213(a) would still apply.

3. Release in Emergency Situations

EPA is proposing two amendments intended to clarify what personnel
could be allowed access to CBI in the event of an emergency under
Sec. 2.307(h)(2). First, EPA proposes to define the term ``qualified
persons'' to include any person whose presence or services are required
for the prevention or mitigation of imminent harm to persons, property,
or the environment, and who requires access to confidential information
in order to perform his or her duties in that capacity. Second, EPA
proposes to clarify that the term ``governmental agencies'' in that
section include federal, State, and local governments.

4. Pesticide Export Policy

On January 12, 1990 EPA published a Federal Register notice (55 FR
1261) indicating the Agency's position that the producer identity,
exporter identity, name of unregistered pesticide, and name of active
ingredient in export notifications under FIFRA section 17(a)(2) were
not entitled to confidentiality. On April 25, 1991 EPA issued Class
Determination 1-91, which provided that the identities of importing
countries in purchaser acknowledgement statements were not entitled to
confidentiality. This Class Determination was published in the February
18, 1993 policy statement governing exported pesticides (58 FR 9062).
That policy statement also refined the Agency's position with respect
to confidentiality of data concerning research and development
products, stating that these products may in some cases be eligible for
confidential treatment. EPA proposes to codify this position in
Sec. 2.307(g)(2). For details concerning this position, see 55 FR 1261.

Executive Order 12866

Under Executive Order 12866 (58 FR 51735 (October 4, 1993)) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.

Paperwork Reduction Act

The information collection requirements in this proposed rule have
been submitted for approval to OMB under the Paperwork Reduction Act,
44 U.S.C. 3501 et seq. An Information Collection Request (ICR) has been
prepared by EPA (ICR No. 1667.01) and a copy may be obtained from Sandy
Farmer, Information Policy Branch (2136); U.S. Environmental Protection
Agency; 401 M Street, SW., Washington, DC 20460 or by calling (2

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-28146. Public record. Not legal advice.