Public Information and Confidentiality Regulations; Proposed Rule ENVIRONMENTAL PROTECTION AGENCY

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 (202)

260-2740.

The public reporting burden for this collection of information is

estimated to average 3.3 hours per response, including the time for

rule familiarization, gathering necessary data, drafting a

substantiation, submitting the substantiation, and recordkeeping for

the information collection. Send comments regarding the burden estimate

or any other aspect of this collection of information, including

suggestions for reducing this burden, to Chief, Information Policy

Branch (2136); U.S. Environmental Protection Agency; 401 M Street, SW.,

Washington, DC 20460; and to the Office of Information and Regulatory

Affairs, Office of Management and Budget, Washington, DC 20503, marked

``Attention: Desk Officer for EPA.'' The final rule will respond to any

OMB or public comments on the information collection requirements

contained in this proposal.

Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act, 5

U.S.C. 605(b), the Administrator certifies that this rule would not

have a significant economic impact on a substantial number of small

entities. The Act requires identification of those regulations which

are likely to have a ``significant economic impact on a substantial

number of small entities,'' i.e., small governments, small businesses,

and small non-profit organizations. Under the requirements of the Act,

such regulations must be subjected to a regulatory flexibility

analysis. This analysis must address the likely economic impacts on

small entities and must consider any significant alternatives to the

rule which accomplish the objectives of applicable statutes and which

minimize any significant economic impact of the rulemaking on small

entities. In April 1992, EPA adopted a new policy which goes beyond the

minimum requirements of the Act (this policy applies to rulemaking

initiated after April 8, 1992). For rules subject to this new policy,

EPA will perform a regulatory flexibility analysis if the rule is

likely to have any economic impact on any small entity.

EPA has performed an Initial Regulatory Flexibility Analysis for

the changes in Agency confidentiality regulations proposed here. It is

available for comment from Donald A. Sadowsky, General and Information

Law Division (2379), Office of General Counsel, Environmental

Protection Agency, 401 M Street SW., Washington, DC 20460. The Agency

has identified as an impact the reporting burden discussed in the

Information Collection Request (see Paperwork Reduction Act discussion

above), deriving from (1) the requirement (discussed in section B.2.,

above) to substantiate claims of confidentiality asserted for an entire

document (as opposed to portions of the document), and (2) new proposed

TSCA-specific signature and up-front substantiation requirements

(discussed in sections W.1 and W.2, above). The estimated burdens for

respondents would be $347.53 (general provisions), $157.36 (TSCA-

specific signature), and $212.47 (TSCA-specific up-front

substantiation). EPA estimates that 285 respondents per year would

incur the burden pertaining to general provisions, 5,313 for TSCA-

specific signature, and 360 for TSCA-specific up-front substantiation.

An unknown number of these respondents would be small entities. The

Agency made the burden for the general provisions as low as possible,

choosing not to require respondents to answer the full series of

questions posed when the Agency must make a determination of

confidentiality when information is requested under FOIA. Any submitter

may avoid this burden completely by merely identifying which portions

of the submitted document should be protected as confidential. With

respect to the TSCA-specific provisions, flexibility in the TSCA-

specific regulations exists for small entities because small entities

are largely exempt from TSCA reporting requirements.

List of Subjects

40 CFR Part 2

Administrative practice and procedure, Confidential business

information, Courts, Freedom of information, Government employees.

40 CFR Part 57

Administrative practice and procedure, Air pollution control,

Metals, Reporting and recordkeeping requirements, Research, Sulfur

oxides.

40 CFR Part 85

Confidential business information, Imports, Labeling, Motor vehicle

pollution, Reporting and recordkeeping requirements, Research,

Warranties.

40 CFR Part 86

Administrative practice and procedure, Confidential business

information, Labeling, Motor vehicle pollution, Reporting and

recordkeeping requirements.

40 CFR Part 122

Administrative practice and procedure, Confidential business

information, Hazardous substances, Reporting and recordkeeping

requirements, Water pollution control.

40 CFR Part 123

Administrative practice and procedure, Confidential business

information, Hazardous substances, Indians--lands, Intergovernmental

relations, Penalties, Reporting and recordkeeping requirements, Water

pollution control.

40 CFR Part 145

Confidential business information, Indians--lands,

Intergovernmental relations, Penalties, Reporting and recordkeeping

requirements, Water supply.

40 CFR Part 233

Administrative practice and procedure, Intergovernmental relations,

Penalties, Reporting and recordkeeping requirements, Water pollution

control.

40 CFR Part 260

Administrative practice and procedure, Confidential business

information, Hazardous waste.

40 CFR Part 270

Administrative practice and procedure, Confidential business

information, Hazardous materials transportation, Hazardous waste,

Reporting and recordkeeping requirements, Water pollution control,

Water supply.

40 CFR Part 271

Administrative practice and procedure, Confidential business

information, Hazardous materials transportation, Hazardous waste,

Indians-lands, Intergovernmental relations, Penalties, Reporting and

recordkeeping requirements, Water pollution control, Water supply.

40 CFR Part 281

Administrative practice and procedure, Hazardous substances,

Insurance, Intergovernmental relations, Oil pollution, Reporting and

recordkeeping requirements, Surety bonds, Water pollution control,

Water supply.

40 CFR Part 350

Administrative practice and procedure, Chemicals, Confidential

business information, Disaster assistance, Hazardous substances,

Hazardous waste, Intergovernmental relations, Natural resources,

Reporting and recordkeeping requirements, Superfund, Water pollution

control, Water supply.

40 CFR Part 403

Confidential business information, Reporting and recordkeeping

requirements, Waste treatment and disposal, Water pollution control.

40 CFR Part 704

Environmental protection, Chemicals, Confidential business

information, Hazardous substances, Imports, Reporting and recordkeeping

requirements.

40 CFR Part 707

Environmental protection, Chemicals, Exports, Hazardous substances,

Imports, Confidential business information, Reporting and recordkeeping

requirements.

40 CFR Part 710

Environmental protection, Chemicals, Inventory, Partial Updating of

the inventory data base, Confidential business information, Reporting

and recordkeeping requirements.

40 CFR Part 712

Environmental protection, Chemicals, Confidential business

information, Reporting and recordkeeping requirements.

40 CFR Part 716

Environmental protection, Chemicals, Hazardous substances, Health

and safety, Confidential business information, Reporting and

recordkeeping requirements.

40 CFR Part 717

Environmental protection, Chemicals, Confidential business

information, Reporting and recordkeeping requirements, Significant

adverse reactions.

40 CFR Part 720

Environmental protection, Chemicals, Premanufacture notification,

Hazardous materials, Confidential business information, Reporting and

recordkeeping requirements.

40 CFR Part 723

Environmental protection, Chemicals, Premanufacture notification,

Hazardous materials, Confidential business information, Reporting and

recordkeeping requirements.

40 CFR Part 750

Administrative practice and procedure, Chemicals, Confidential

business information, Reporting and recordkeeping requirements.

40 CFR Part 790

Environmental protection, Chemicals, Testing, Hazardous substances,

Confidential business information, Reporting and recordkeeping

requirements.

Dated: November 3, 1994.

Carol M. Browner,

Administrator.

Therefore 40 CFR parts 2, 57, 85, 86, 122, 123, 145, 233, 260, 270,

271, 281, 350, 403, 704, 707, 710, 712, 716, 717, 720, 723, 750 and 790

are proposed to be amended as follows:

PART 2--[AMENDED]

The authority citation for part 2 is revised to read as follows:

Authority: 5 U.S.C. 301, 552 (as amended), 553; secs. 114, 206,

208, 301, and 307, Clean Air Act, as amended (42 U.S.C. 7414, 7525,

7542, 7601, 7607); secs. 308, 501 and 509(a), Clean Water Act, as

amended (33 U.S.C. 1318, 1361, 1369(a)); sec. 13, Noise Control Act

of 1972 (42 U.S.C. 4912); secs. 1445 and 1450, Safe Drinking Water

Act (42 U.S.C. 300j-4, 300j-9); secs. 2002, 3007, and 9005, Solid

Waste Disposal Act, as amended (42 U.S.C. 6912, 6927, 6991d); secs.

8(c), 11, 12(b), and 14, Toxic Substances Control Act (15 U.S.C.

2607(c), 2610, 2611(b), 2613); secs. 10, 12, and 25, Federal

Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C.

136h, 136j, 136w); sec. 408(f), Federal Food, Drug and Cosmetic Act,

as amended (21 U.S.C. 346(f)); secs. 104(f) and 108, Marine

Protection, Research and Sanctuaries Act of 1972 (33 U.S.C. 1414(f),

1418); secs. 104, 115, Comprehensive Environmental Response,

Compensation, and Liability Act of 1980, as amended (42 U.S.C. 9604,

9615); sec. 505, Motor Vehicle Information and Cost Savings Act, as

amended (15 U.S.C. 2005).

2. Section 2.111 is amended by revising paragraph (a)(4) to read as

follows:

Sec. 2.111 Action by office responsible for responding to request.

(a) * * *

(4) If any located records contain business information, as defined

in Sec. 2.201(c), comply with subpart B of this part. However, if the

request encompasses information claimed as business confidential

pursuant to subpart B of this part but is silent on whether the

requestor desires information subject to a claim of confidentiality,

the office shall presume that such information is excluded from the

scope of the request, and need not take the actions required by

Sec. 2.204(d). Nonetheless the office shall provide the requestor with

a description of those records claimed as confidential which would have

been within the scope of the request had the presumption in this

paragraph not been applied;

* * * * *

3. Section 2.113 is amended by revising paragraph (a)(1) to read as

follows:

Sec. 2.113 Initial denial of requests.

(a) * * *

(1) A statutory provision, provision of this part, or court order

requires that the information not be disclosed (information withheld

pursuant to section 10(g) of the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136h(g)) will be handled pursuant to

procedures in Sec. 2.307(j) of this part);

* * * * *

4. Part 2, subpart B is revised to read as follows:

Subpart B--Confidential Business Information.

Sec.

2.201 Definitions.

2.202 Applicability of subpart; priority where provisions conflict;

records containing more than one kind of information.

2.203 Notice to be included in EPA requests, demands, and forms;

method of asserting business confidentiality claim; effect of

failure to assert claim at time of submission.

2.204 Initial action by EPA office.

2.205 Final confidentiality determination by EPA legal office.

2.206 Advance confidentiality determinations.

2.207 Class determinations.

2.208 Substantive criteria for use in confidentiality

determinations.

2.209 Disclosure in special circumstances.

2.210 Nondisclosure for reasons other than business confidentiality

or where disclosure is prohibited by other statute.

2.211 Safeguarding of business information; penalty for wrongful

disclosure.

2.212 Establishment of control offices for categories of business

information.

2.213 Designation by business of addressee for notices and

inquiries.

2.214 Defense of Freedom of Information Act suits; participation by

affected business.

2.215 Confidentiality agreements.

2.216 Sunset Provisions for Confidentiality Claims.

2.217-2.300 [Reserved].

2.301 Special rules governing certain information obtained under

the Clean Air Act.

2.302 Special rules governing certain information obtained under

the Clean Water Act.

2.303 Special rules governing certain information obtained under

the Noise Control Act of 1972.

2.304 Special rules governing certain information obtained under

the Safe Drinking Water Act.

2.305 Special rules governing certain information obtained under

the Solid Waste Disposal Act, as amended.

2.306 Special rules governing certain information obtained under

the Toxic Substances Control Act.

2.307 Special rules governing certain information obtained under

the Federal Insecticide, Fungicide and Rodenticide Act.

2.308 Special rules governing certain information obtained under

the Federal Food, Drug and Cosmetic Act.

2.309 Special rules governing certain information obtained under

the Marine Protection, Research and Sanctuaries Act of 1972.

2.310 Special rules governing certain information obtained under

the Comprehensive Environmental Response, Compensation, and

Liability Act of 1980, as amended.

2.311 Special rules governing certain information obtained under

the Motor Vehicle Information and Cost Savings Act.

Sec. 2.201 Definitions.

For the purposes of this subpart:

(a) Person means an individual, partnership, corporation,

association, or other public or private organization or legal entity,

including Federal, State or local governmental bodies and agencies and

their employees.

(b) Business means any person engaged in a business, trade,

employment, calling or profession, whether or not all or any part of

the net earnings derived from such engagement by such person inure (or

may lawfully inure) to the benefit of any private shareholder or

individual.

(c) Business information (sometimes referred to simply as

information) means any information which pertains to the interests of

any business, which was developed or acquired by that business, and

(except where the context otherwise requires) which is possessed by EPA

in recorded form.

(d) Affected business means, with reference to an item of business

information, a business which has asserted (and not waived or

withdrawn) a business confidentiality claim covering the information,

or a business which could be expected to make such a claim if it were

aware that disclosure of the information to the public was proposed.

(e) Reasons of business confidentiality include the concept of

trade secrecy and other related legal concepts which give (or may give)

a business the right to preserve the confidentiality of business

information and to limit its use or disclosure by others in order that

the business may obtain or retain business advantages it derives from

its rights in the information. The definition is meant to encompass any

concept which authorizes a Federal agency to withhold business

information under 5 U.S.C. 552(b)(4), as well as any concept which

requires EPA to withhold information from the public for the benefit of

a business under 18 U.S.C. 1905 or any of the various statutes cited in

Secs. 2.301 through 2.311.

(f) [Reserved]

(g) Information which is available to the public is information in

EPA's possession which EPA will furnish to any member of the public

upon request and which EPA may make public, release or otherwise make

available to any person whether or not its disclosure has been

requested.

(h) Business confidentiality claim (or, simply, claim) means a

claim or allegation that business information is entitled to

confidential treatment for reasons of business confidentiality, or a

request for a determination that such information is entitled to such

treatment.

(i) [Reserved]

(j) Recorded means written or otherwise registered in some form for

preserving information, including such forms as drawings, photographs,

videotape, sound recordings, punched cards, and computer tape or disk.

(k) [Reserved]

(l) Administrator, Regional Administrator, General Counsel,

Regional Counsel, and Freedom of Information Officer mean the EPA

officers or employees occupying the positions so titled (or designated

to act in such position).

(m) EPA office means any organizational element of EPA, at any

level or location. (The terms EPA office and EPA legal office are used

in this subpart for the sake of brevity and ease of reference. When

this subpart requires that an action be taken by an EPA office or by an

EPA legal office, it is the responsibility of the officer or employee

in charge of that office to take the action or ensure that it is

taken.)

(n) EPA legal office means the EPA General Counsel, any EPA office

over which the General Counsel exercises supervisory authority, and the

various Offices of Regional Counsel. (See paragraph (m) of this

section.)

(o) A working day is any day on which Federal government offices

are open for normal business. Saturdays, Sundays, and official Federal

holidays are not working days; all other days are.

Sec. 2.202 Applicability of subpart; priority where provisions

conflict; records containing more than one kind of information.

(a) Sections 2.201 through 2.216 establish basic rules governing

business confidentiality claims, the handling by EPA of business

information which is or may be entitled to confidential treatment, and

determinations by EPA of whether information is entitled to

confidential treatment for reasons of business confidentiality.

(b) Various statutes (other than 5 U.S.C. 552) under which EPA

operates contain special provisions concerning the entitlement to

confidential treatment of information gathered under such statutes.

Sections 2.301 through 2.311 prescribe rules for treatment of certain

categories of business information obtained under the various statutory

provisions. Paragraph (b) of each of those sections should be consulted

to determine whether any of those sections applies to the particular

information in question.

(c) The basic rules of Secs. 2.201 through 2.216 govern except to

the extent that they are modified or supplanted by the special rules of

Secs. 2.301 through 2.311. In the event of a conflict between the

provisions of the basic rules and those of a special rule which is

applicable to the particular information in question, the provision of

the special rule shall govern.

(d) If two or more of the sections containing special rules apply

to the particular information in question, and the applicable sections

prescribe conflicting special rules for the treatment of the

information, the rule which provides greater or wider availability to

the public of the information shall govern.

(e) For most purposes, a document or other record may usefully be

treated as a single unit of information, even though in fact the

document or record is comprised of a collection of individual items of

information. However, in applying the provisions of this subpart, it

will often be necessary to separate the individual items of information

into two or more categories, and to afford different treatment to the

information in each such category. The need for differentiation of this

type may arise, e.g., because a business confidentiality claim covers

only a portion of a record, or because only a portion of the record is

eligible for confidential treatment. EPA offices taking action under

this subpart must be alert to this problem.

(f) In taking actions under this subpart, EPA offices are not

required to obtain the affected business' consent to disclosure of

useful portions of records while protecting the information which is or

may be entitled to confidentiality (e.g., by withholding such portions

of a record as would identify a business, or by disclosing data in the

form of industry-wide aggregates, multi-year averages or totals, or

some similar form). However, when disclosing portions of a record,

offices must ensure that the portions disclosed do not contain

information claimed as confidential under this subpart. Offices may not

disclose aggregated numerical data except where the aggregate was

calculated using a methodology on which an EPA legal office has been

consulted.

(g) This subpart does not apply to questions concerning entitlement

to confidential treatment or information which concerns an individual

solely in his personal, as opposed to business, capacity.

Sec. 2.203 Notice to be included in EPA requests, demands, and forms;

method of asserting business confidentiality claim; effect of failure

to assert claim at time of submission.

(a) Notice to be included in certain requests and demands for

information, and in certain forms. Whenever an EPA office makes a

written request or demand that a business furnish information which, in

the office's opinion, is likely to be regarded by the business as

entitled to confidential treatment under this subpart, or whenever an

EPA office prescribes a form for use by businesses in furnishing such

information, the request, demand, or form shall include or enclose a

notice which--

(1) States that the business may, if it desires, assert a business

confidentiality claim covering part or all of the information, in the

manner described by paragraph (b) of this section, and that information

covered by such a claim will be disclosed by EPA only to the extent,

and by means of the procedures, set forth in this subpart;

(2) States that if no such claim accompanies the information when

it is received by EPA, it may be made available to the public without

further notice to the business; and

(3) Furnishes a citation of the location of this subpart in the

Code of Federal Regulations.

(b) Method and time of asserting business confidentiality claim.

(1) A business which is submitting information to EPA may assert a

business confidentiality claim covering the information by placing on

(or attaching to) the information, at the time it is submitted to EPA,

a cover sheet, stamped or typed legend, or other suitable form of

notice employing language such as trade secret, proprietary, or company

confidential. Allegedly confidential portions of otherwise non-

confidential documents must be clearly identified by the business, and

may be submitted separately to facilitate identification and handling

by EPA. If the business desires confidential treatment only until a

certain date or until the occurrence of a certain event, the notice

should so state.

(2) A confidentiality claim asserted on or after [insert effective

date of final rule] which does not identify those portions of the

document which are allegedly confidential will not be recognized by EPA

unless the claim is accompanied by a substantiation of why the entire

document (as opposed to portions of the document) meets the criteria

for confidentiality set forth in Sec. 2.208. Section 2.205(c) applies

to substantiations submitted under this paragraph.

(3) Where a specific submission to EPA is claimed as confidential

and is subject to an EPA regulation which requires that documentation

substantiating a confidentiality claim (addressing or expanding upon

the criteria for confidentiality in Sec. 2.208) be submitted to the

Agency at the same time the business submits the information claimed to

be confidential, and a business fails to provide the same, EPA will not

recognize the confidentiality claim.

(c) Effect of failure to assert claim at time of submission of

information. (1) Where information received by EPA is unaccompanied by

a business confidentiality claim, the inquiry to the business required

by Sec. 2.204(c)(2) need not be made provided that EPA does not have

substantial reason to believe that disclosure would result in

competitive harm if either--

(i) The information was submitted by a business to EPA before

[insert effective date of final rule] in response to an EPA request or

demand (or on an EPA-prescribed form) which contained the substance of

the notice required by paragraph (a) of this section; or

(ii) The information was submitted by a business to EPA on or after

[insert effective date of final rule].

(2) If a claim covering the information is received after the

information itself is received, EPA will make such efforts as are

administratively practicable to associate the late claim with copies of

the previously-submitted information in EPA files (see

Sec. 2.204(c)(1)). However, EPA cannot assure that such efforts will be

effective, in light of the possibility of prior disclosure or

widespread prior dissemination of the information.

Sec. 2.204 Initial action by EPA office.

(a) Situations requiring action. This section prescribes procedures

to be used by EPA offices in making initial determinations of whether

business information is entitled to confidential treatment for reasons

of business confidentiality. Action shall be taken under this section

whenever an EPA office:

(1) Learns that it is responsible for responding to a request under

5 U.S.C. 552 for the release of business information; in such a case,

the office shall issue an initial determination within the period

specified in Sec. 2.112. However, if pursuant to Sec. 2.111(a)(4) the

request is presumed not to include information claimed as confidential,

the office shall take those actions required by paragraph (c) of this

section to determine the existence of confidentiality claims, but shall

not take action under paragraph (b) or (d) of this section;

(2) Desires to determine whether business information in its

possession is entitled to confidential treatment, even though no

request for release of the information has been received; or

(3) Determines that it is likely that EPA eventually will be

requested to disclose the information at some future date and thus will

have to determine whether the information is entitled to confidential

treatment. In such a case this section's procedures should be initiated

at the earliest practicable time, in order to increase the time

available for preparation and submission of comments and for issuance

of determinations, and to make easier the task of meeting response

deadlines if a request for release of the information is later received

under 5 U.S.C. 552.

(b) Previous confidentiality determination. The EPA office shall

first ascertain whether there has been a previous determination, issued

by a Federal court or by an EPA legal office acting under this subpart,

as to whether the information in question is entitled to confidential

treatment for reasons of business confidentiality. The office shall

also take into account any determination of confidentiality (of which

the office is aware) issued by a State or local government entity.

(1) If a determination issued by a Federal court or by an EPA legal

office holds that the information is entitled to confidential

treatment, the EPA Office shall furnish any person whose request for

the information is pending under 5 U.S.C. 552 an initial determination

(see Secs. 2.111 and 2.113) that the information has previously been

determined to be entitled to confidential treatment, and that the

request is therefore denied. The office shall furnish such person the

appropriate case citation or EPA determination. If the EPA office

believes that a previous determination which was issued by an EPA legal

office may be improper or no longer valid, the office shall so inform

the EPA legal office, which shall consider taking action under

Sec. 2.205(h).

(2) If a determination issued by a Federal court or by an EPA legal

office holds that the information is not entitled to confidential

treatment, the EPA office may proceed pursuant to Sec. 2.204(d)(2).

(3) If a determination issued by a Federal agency or by a State or

local government entity holds that the information is not entitled to

confidential treatment, and the information is available to the public

from the State or local government entity, the EPA office may proceed

pursuant to Sec. 2.204(d)(2).

(4) With respect to all information not known to be covered by any

of paragraphs (b) (1)-(3) of this section, the EPA office shall take

action under paragraph (c) of this section.

(c) Determining existence of business confidentiality claims.

(1) Whenever action under this paragraph is required by paragraph

(a)(1) or (b)(4) of this section, the EPA office shall examine the

information and the office's records to determine which businesses, if

any, are affected businesses (see Sec. 2.201(d)), and to determine

which businesses, if any, have asserted business confidentiality claims

which remain applicable to the information. If any business is found to

have asserted an applicable claim (and the request, if any, under 5

U.S.C. 552 has not been presumed to exclude information claimed as

confidential pursuant to Sec. 2.111(a)(4)), the office shall take

action under paragraph (d) of this section with respect to each such

claim.

(2)(i) If the examination conducted under paragraph (c)(1) of this

section discloses the existence of any business which, although it has

not asserted a claim, might be expected to assert a claim if it knew

EPA proposed to disclose the information, the EPA office shall contact

a responsible official of each such business to learn whether the

business asserts a claim covering the information. However, unless EPA

has substantial reason to believe that disclosure of the information

would result in competitive harm, no such inquiry need be made--

(A) To any business which failed to assert a claim covering the

information when responding to an EPA request or demand, or supplying

information on an EPA form, which contained the substance of the

statements prescribed by Sec. 2.203(a);

(B) To any business which otherwise failed to assert a claim

covering the information after being informed by EPA that such failure

could result in disclosure of the information to the public;

(C) To any business which has otherwise waived or withdrawn a claim

covering the information; or

(D) With respect to information submitted on or after [insert

effective date of final rule].

(ii) If a request for release of the information under 5 U.S.C. 552

is pending at the time inquiry is made under this paragraph (c)(2), the

inquiry shall be made by telephone or equally prompt means, and the

responsible official contacted shall be informed that any claim the

business wishes to assert must be brought to the EPA office's attention

no later than the close of business on the third working day after such

inquiry.

(iii) A record shall be kept of the results of any inquiry under

this paragraph (c)(2) of this section. If any business makes a claim

covering the information, and the request, if any, under 5 U.S.C. 552

has not been presumed to exclude information claimed as confidential

pursuant to Sec. 2.111(a)(4)), the EPA office shall take further action

under paragraph (d) of this section.

(3) If, after the examination under paragraph (c)(1) of this

section, and after any inquiry made under paragraph (c)(2) of this

section, the EPA office knows of no claim covering the information and

the time for response to any inquiry has passed, the information shall

be treated for purposes of this subpart as not entitled to confidential

treatment.

(d) Preliminary determination. Whenever action under this paragraph

is required by paragraph (c) (1) or (2) of this section on any

business' claim, the EPA Office shall make a determination with respect

to each such claim. Each determination shall be made after

consideration of the provisions of Sec. 2.203, the applicable

substantive criteria in Sec. 2.208 or elsewhere in this subpart, and

any previously-issued determinations under this subpart which are

applicable.

(1) If, in connection with any business' claim, the office

determines that the information may be entitled to confidential

treatment, the office shall--

(i) Furnish the notice of opportunity to submit comments prescribed

by paragraph (e) of this section to each business which is known to

have asserted an applicable claim and which has not previously been

furnished such notice with regard to the information in question;

(ii) Furnish, to any person whose request for release of the

information is pending under 5 U.S.C. 552, a determination (in

accordance with Sec. 2.113) that the information may be entitled to

confidential treatment under this subpart and 5 U.S.C. 552(b)(4), that

further inquiry by EPA pursuant to this subpart is required before a

final determination on the request can be issued, that the person's

request is therefore initially denied, and that after further inquiry a

final determination will be issued by an EPA legal office; and

(iii) Refer the matter to the appropriate EPA legal office,

furnishing the information required by paragraph (f) of this section

after the time has elapsed for receipt of comments from the affected

business.

(2) If, in connection with all applicable claims, the office

determines that the information clearly is not entitled to confidential

treatment, the office shall take the actions required by Sec. 2.205(f).

However, if a business has previously been furnished notice under

Sec. 2.205(f) with respect to the same information, no further notice

need be furnished to that business. A copy of each notice furnished to

a business under this paragraph (d)(2) and Sec. 2.205(f) shall be

forwarded promptly to the appropriate EPA legal office.

(3)(i) A business has waived its confidentiality claim if--

(A) The EPA office designated to receive the business' comments

(pursuant to paragraph (d)(1)(i)) has not received those comments

within the specified time, including any approved extension, (after

making appropriate inquiry on whether the comments were lost in

transmission) under Sec. 2.205(b); and

(B) 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.

(ii) If, after application of the preceding paragraph (i), no

confidentiality claim applies to the information, the office shall

determine that the information is not entitled to confidential

treatment under this subpart and, subject to Sec. 2.210, is available

to the public and may be disclosed without notice to any business.

(e) Notice to affected businesses; opportunity to comment. (1)

Whenever required by paragraph (d)(1) of this section, the EPA office

shall promptly furnish each business a written notice stating that EPA

is determining under this subpart whether the information is entitled

to confidential treatment, and affording the business an opportunity to

comment. The notice shall be furnished by certified mail (return

receipt requested), by personal delivery, or by other means which

allows verification of the fact and date of receipt. The notice shall

state the address of the office to which the business' comments shall

be addressed (the EPA office furnishing the notice, unless the General

Counsel has directed otherwise), the time allowed for comments, and the

method for requesting a time extension under Sec. 2.205(b)(2). The

notice shall further state that EPA will construe a business' failure

to furnish timely comments as a waiver of the business' claim.

(2) If action under this section is occasioned by a request for the

information under 5 U.S.C. 552, the period for comments shall be 15

working days after the date of the business' receipt of the written

notice. In other cases, the EPA office shall establish a reasonable

period for comments (not less than 15 working days after the business'

receipt of the written notice). The time period for comments shall be

considered met if the business' comments are postmarked or hand

delivered to the office designated in the notice by the date specified.

In all cases, the notice shall call the business' attention to the

provisions of Sec. 2.205(b).

(3) The written notice required by paragraph (e)(1) of this section

shall invite the business' comments on the following points (subject to

paragraph (e)(4) of this section):

(i) The portions of the information which are alleged to be

entitled to confidential treatment;

(ii) The period of time for which confidential treatment is desired

by the business (e.g., until a certain date, until the occurrence of a

specified event, or permanently);

(iii) The purpose for which the information was furnished to EPA

and the approximate date of submission, if known;

(iv) Whether a business confidentiality claim accompanied the

information when it was received by EPA;

(v) Measures taken by the business to guard against undesired

disclosure of the information to others;

(vi) The extent to which the information has been disclosed to

others, and the precautions taken in connection therewith;

(vii) Pertinent confidentiality determinations, if any, by EPA or

other Federal agencies, as well as by State and local governmental

entities, and a copy of any such determination, or reference to it, if

available;

(viii) Whether the business asserts that disclosure of the

information would be likely to result in substantial harmful effects on

the business' competitive position, and if so, what those harmful

effects would be, why they should be viewed as substantial, and an

explanation of the causal relationship between disclosure and such

harmful effects; and

(ix) Whether and why disclosure of the information would tend to

lessen the availability to EPA of similar information in the future.

(4)(i) To the extent that the EPA office already possesses the

relevant facts, the notice need not solicit responses to the matters

addressed in paragraph (e)(3) (i) through (ix) of this section,

although the notice shall request confirmation of EPA's understanding

of such facts where appropriate.

(ii) If the EPA office believes that the information submitted to

EPA was submitted voluntarily, the notice need not solicit responses to

the matters addressed in paragraph (e)(3)(viii) of this section. If,

upon examination of the information provided to an EPA legal office

pursuant to paragraph (f) of this section, the legal office believes

that the information was not voluntarily submitted, the legal office

shall solicit responses to the matters addressed in paragraph

(e)(3)(viii) of this section, pursuant to the procedures of this

paragraph (e).

(5) The notice shall refer to Sec. 2.205(c) and shall include the

statement prescribed by Sec. 2.203(a).

(f) Materials to be furnished to EPA legal office. When a matter is

referred to an EPA legal office under paragraph (d)(1) of this section,

the EPA office taking action under this section shall for

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