[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-28146] [[Page Unknown]] [Federal Register: November 23, 1994] _______________________________________________________________________ Part III Environmental Protection Agency _______________________________________________________________________ 40 CFR Part 2, et al. Public Information and Confidentiality Regulations; Proposed Rule ENVIRONMENTAL PROTECTION AGENCY 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 [FRL-4736-2] RIN 2020-AA21 Public Information and Confidentiality Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- 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 forward promptly to the EPA legal office the following items: (1) A copy of the information in question, or (where the quantity or form of the information makes forwarding a copy of the information impractical) representative samples, a description of the information, or both; (2) A description of the circumstances and date of EPA's acquisition of the information; (3) The name, address, and telephone number of the EPA employee(s) most familiar with the information; (4) The name, address and telephone number of each business which asserts an applicable business confidentiality claim; (5) A copy of each applicable claim (or the record of the assertion of the claim), and a description of when and how each claim was asserted; (6) Comments concerning each business' compliance or noncompliance with applicable requirements of Sec. 2.203; (7) A copy of any request for release of the information pending under 5 U.S.C. 552; (8) A copy of the business' comments on whether the information is entitled to confidential treatment; (9) The office's comments concerning the appropriate substantive criteria under this subpart, and information the office possesses concerning the information's entitlement to confidential treatment; and (10) Copies of other correspondence or memoranda which pertain to the matter. Sec. 2.205 Final confidentiality determination by EPA legal office. (a) Role of EPA legal office. (1) The appropriate EPA legal office (see paragraph (i) of this section) is responsible for making the final administrative determination of whether or not business information covered by a business confidentiality claim is entitled to confidential treatment under this subpart. (2) When a request for release of the information under 5 U.S.C. 552 is pending, the EPA legal office's determination shall serve as the final determination on appeal from an initial denial of the request. (i) If the initial denial was issued under Sec. 2.204(b)(1), a final determination by the EPA legal office is necessary only if the requestor has actually filed an appeal. (ii) If the initial denial was issued under Sec. 2.204(d)(1), however, the EPA legal office shall issue a final determination in every case, unless the request has been withdrawn. (Initial denials under Sec. 2.204(d)(1) are of a procedural nature, to allow further inquiry into the merits of the matter, and a requestor is entitled to a decision on the merits.) If an appeal from such a denial has not been received by the EPA Freedom of Information Officer on the tenth working day after issuance of the denial, the matter shall be handled as if an appeal had been received on that day, for purposes of establishing a schedule for issuance of an appeal decision under Sec. 2.117 of this part. (b) Comment period; extensions. (1) Each business which has been furnished the notice and opportunity to comment prescribed by Secs. 2.204(d)(1) and 2.204(e) shall furnish its comments to the office specified in the notice in time to be postmarked or hand delivered to that office not later than the date specified in the notice (or the date established in lieu thereof under this section). (2) The period for submission of comments may be extended if, before the comments are due, a request for an extension of the comment period is made by the business and approved by the EPA legal office. Except in extraordinary circumstances, the EPA legal office will not approve such an extension without the consent of any person whose request for release of the information under 5 U.S.C. 552 is pending. (3) The period for submission of comments by a business may be shortened in the manner described in paragraph (g) of this section. (4) If a business' comments have not been received by the specified EPA office by the date they are due (including any approved extension), that office shall promptly inquire whether the business has complied with paragraph (b)(1) of this section. If the business has complied with paragraph (b)(1) of this section but the comments have been lost in transmission, duplicate comments shall be requested. (c) Confidential treatment of comments from business. If information is submitted to EPA by a business as part of its comments under this section or as part of a substantiation pursuant to Sec. 2.203(b)(2), pertains to the business' claim, is not otherwise possessed by EPA, and is marked when received in accordance with Sec. 2.203(b)(1), it will be regarded by EPA as entitled to confidential treatment and will not be disclosed by EPA without the business' consent, unless its disclosure is duly ordered by a Federal court, notwithstanding other provisions of this subpart to the contrary. (d) Types of final determinations; matters to be considered. (1) The EPA legal office shall consider each business' claim and comments (provided that the claim is not waived or otherwise rendered ineffective by any provision of this subpart), the various provisions of this subpart, any previously-issued determinations under this subpart which are pertinent, the materials furnished it under Sec. 2.204(f), and such other materials as it finds appropriate. With respect to each claim, the office shall determine whether or not the information is entitled to confidential treatment for the benefit of the business that asserted the claim, and the period of any such entitlement (e.g., until a certain date, until the occurrence of a specified event, or permanently), and shall take further action under paragraph (e) or (f) of this section, as appropriate. (2) Whenever the claims of two or more businesses apply to the same information, the EPA legal office shall take action appropriate under the particular circumstances to protect the interests of all persons concerned (including any person whose request for the information is pending under 5 U.S.C. 552). (e) Determination that information is entitled to confidential treatment. If the EPA legal office determines that the information is entitled to confidential treatment for the full period requested by the business which made the claim, EPA shall maintain the information in confidence for such period, subject to paragraph (h) of this section, Sec. 2.209, and the other provisions of this subpart which authorize disclosure in specified circumstances, and the office shall so inform the business. If any person's request for the release of the information is then pending under 5 U.S.C. 552, the EPA legal office shall issue a final determination denying that request. (f) Determination that information is not entitled to confidential treatment; notice; waiting period; release of information. (1) Notice of denial (or partial denial) of a business confidentiality claim, in the form prescribed by paragraph (f)(2) of this section, shall be furnished-- (i) By the EPA office taking action under Sec. 2.204, to each business on behalf of which a claim has been made, whenever Sec. 2.204(d)(2) requires such notice; and (ii) By the EPA legal office taking action under this section, to each business which has asserted a claim applicable to the information and which has furnished timely comments under paragraph (b) of this section, whenever the EPA legal office determines that the information is not entitled to confidential treatment under this subpart for the benefit of the business, or determines that the period of any entitlement to confidential treatment is shorter than that requested by the business. (2) The notice prescribed by paragraph (f)(1) of this section shall be written, and shall be furnished by certified mail (return receipt requested), by personal delivery, or by other means which allows verification of the fact of receipt and the date of receipt. The notice shall state the basis for the determination, that it constitutes final agency action concerning the business confidentiality claim, and that such final agency action may be subject to judicial review under Chapter 7 of Title 5, United States Code. With respect to EPA's implementation of the determination, the notice shall state that (subject to Sec. 2.210) EPA will make the information available to the public on the tenth working day after the date of the business' receipt of the written notice (or on such later date as is established in lieu thereof by the EPA legal office under paragraph (f)(3) of this section), unless the EPA legal office has first been notified of the business' commencement of an action in a Federal court to obtain judicial review of the determination and to obtain preliminary injunctive relief against disclosure. The notice shall further state that if such an action is timely commenced, EPA may nonetheless make the information available to the public (in the absence of an order by the court to the contrary) once the court has denied a motion for a preliminary injunction in the action or has otherwise upheld the EPA determination, or whenever it appears to the EPA legal office, after reasonable notice to the business, that the business is not taking appropriate measures to obtain a speedy resolution of the action. If the information has been found to be temporarily entitled to confidential treatment, the notice shall further state that the information will not be disclosed prior to the end of the period of such temporary entitlement to confidential treatment. (3) The period established in a notice under paragraph (f)(2) of this section for commencement of an action to obtain judicial review may be extended if, before the expiration of such period, a request for an extension is made by the business and approved by the EPA legal office, or by any office acting pursuant to Sec. 2.204(d)(2). Except in extraordinary circumstances, the EPA office will not approve such an extension without the consent of any person whose request for release of the information under 5 U.S.C. 552 is pending. (4) After the expiration of any period of temporary entitlement to confidential treatment, a determination under this paragraph (f) of this section shall be implemented by the EPA legal office, or by any office acting pursuant to Sec. 2.204(d)(2) (after consultation with the appropriate legal office) by making the information available to the public (in the absence of a court order prohibiting disclosure) whenever-- (i) The period provided for commencement by a business of an action to obtain judicial review of the determination has expired without notice to the EPA legal office of commencement of such an action; (ii) The court, in a timely-commenced action, has denied the business' motion for a preliminary injunction, or has otherwise upheld the EPA determination; or (iii) The EPA legal office, after reasonable notice has been provided to the business, finds that the business is not taking appropriate measures to obtain a speedy resolution of the timely- commenced action. (5) Any person whose request for release of the information under 5 U.S.C. 552 is pending at the time notice is given under paragraph (f)(2) of this section shall be furnished a determination under 5 U.S.C. 552 stating the circumstances under which the information will be released. (g) Emergency situations. If the General Counsel finds that disclosure of information covered by a claim would be helpful in alleviating a situation posing an imminent and substantial danger to public health or safety, he may prescribe and make known to interested persons such shorter comment period (paragraph (b) of this section), post-determination waiting period (paragraph (f) of this section), or both, as he finds necessary under the circumstances. (h) Modification of prior determinations. A determination that information is entitled to confidential treatment for the benefit of a business, made under this subpart by an EPA legal office, shall continue in effect in accordance with its terms until an EPA legal office taking action under this section, or under Sec. 2.206 or Sec. 2.207, issues a final determination stating that the earlier determination no longer describes correctly the information's entitlement to confidential treatment because of a change in the applicable law, newly-discovered or changed facts, or because the earlier determination was clearly erroneous. If an EPA legal office tentatively concludes that such an earlier determination is of questionable validity, it shall so inform the business, and shall afford the business an opportunity to furnish comments on pertinent issues in the manner described by Sec. 2.204(e) and paragraph (b) of this section. If, after consideration of any timely comments submitted by the business, the EPA legal office makes a revised final determination that the information is not entitled to confidential treatment, or that the period of entitlement to such treatment will end sooner than it would have ended under the earlier determination, the office will follow the procedure described in paragraph (f) of this section. Determinations under this section may be made only by, or with the concurrence of, the General Counsel. (i) Delegation and redelegation of authority. Unless the General Counsel otherwise directs, or this subpart specifically provides, determinations and actions required by this subpart to be made or taken by an EPA legal office shall be made or taken by the appropriate Regional Counsel whenever the EPA office taking action under Sec. 2.204 or Sec. 2.206(b) is under the supervision of a Regional Administrator, and by the General Counsel in all other cases. The General Counsel may redelegate any or all of his authority under this subpart to any attorney employed by EPA under the General Counsel's supervision. A Regional Counsel may redelegate any or all of his authority under this subpart to any attorney employed by EPA under the Regional Counsel's supervision. Sec. 2.206 Advance confidentiality determinations. (a) An advance determination under this section may be issued by an EPA legal office if-- (1) EPA has requested that a business furnish business information to EPA; (2) The business asserts that the information, if submitted, would constitute voluntarily submitted information; (3) The business will voluntarily submit the information for use by EPA only if EPA first determines that the information is entitled to confidential treatment under this subpart; and (4) The EPA office which desires submission of the information has requested that the EPA legal office issue a determination under this section. (b) The EPA office requesting an advance determination under this section shall-- (1) Arrange to have the business furnish directly to the EPA legal office a copy of the information (or, where feasible, a description of the nature of the information sufficient to allow a determination to be made), as well as the business' comments concerning the matters addressed in Sec. 2.204(e)(3), excluding, however, matters addressed in Sec. 2.204 (e)(3)(iii) and (e)(3)(iv); and (2) Furnish to the EPA legal office the materials referred to in Sec. 2.204(f) (3), (7), (8), and (9). (c) In making a determination under this section, the EPA legal office shall first determine whether the information would constitute voluntarily submitted information. If the information would constitute voluntarily submitted information, the legal office shall further determine whether the information is entitled to confidential treatment. (d) If the EPA legal office determines that the information would not constitute voluntarily submitted information, or determines that it would constitute voluntarily submitted information but would not be entitled to confidential treatment, it shall so inform the business and the EPA office which requested the determination, stating the basis of the determination, and shall return to the business all copies of the information which it may have received from the business (except that if a request under 5 U.S.C. 552 for release of the information is received while the EPA legal office is in possession of the information, the legal office shall retain a copy of the information, but shall not disclose it unless ordered by a Federal court to do so). The legal office shall not disclose the information to any other EPA office or employee and shall not use the information for any purpose except the determination under this section, unless otherwise directed by a Federal court. (e) If the EPA legal office determines that the information would constitute voluntarily submitted information and that it is entitled to confidential treatment, it shall so inform the EPA office which requested the determination and the business which submitted it, and shall forward the information to the EPA office which requested the determination. Sec. 2.207 Class determinations. (a) The General Counsel may make and issue a class determination under this section if he finds that-- (1) EPA possesses, or is obtaining, related items of business information; (2) One or more characteristics common to all such items of information will necessarily result in identical treatment for each such item under one or more of the provisions in this subpart, and that it is therefore proper to treat all such items as a class for one or more purposes under this subpart; and (3) A class determination would serve a useful purpose. (b) A class determination shall clearly identify the class of information to which it pertains. (c) A class determination may state that all of the information in the class-- (1) Is, or is not, voluntarily submitted information; (2) Is, or is not, governed by a particular section of this subpart, or by a particular set of substantive criteria under this subpart; (3) Fails to satisfy one or more of the applicable substantive criteria, and is therefore ineligible for confidential treatment; (4) Satisfies one or more of the applicable substantive criteria; or (5) Satisfies one or more of the applicable substantive criteria during a certain period, but will be ineligible for confidential treatment thereafter. (d) The 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 under one or more of the provisions of this subpart. Accordingly, a class determination issued on or after [insert effective date of final rule] must be published in the Federal Register before it may be applied. The notice of opportunity to submit comments referred to in Sec. 2.204(d)(1)(ii) and Sec. 2.205(b), and the list of materials required to be furnished to the EPA legal office under Sec. 2.204(d)(1)(iii), may be modified to reflect the fact that the class determination has made unnecessary the submission of materials pertinent to one or more issues. Moreover, in appropriate cases, action based on the class determination may be taken under Sec. 2.204(b)(1), Sec. 2.204(d), Sec. 2.205(d), or Sec. 2.206. However, the existence of a class determination shall not, of itself, affect any right a business may have to receive any notice under Sec. 2.204(d)(2) or Sec. 2.205(f). Sec. 2.208 Substantive criteria for use in confidentiality determinations. Determinations issued under Secs. 2.204 through 2.207 shall hold that business information is entitled to confidential treatment for the benefit of a particular business if-- (a) The business has asserted a business confidentiality claim which has not expired by its terms, nor been waived nor withdrawn; (b) The business has satisfactorily shown that it has taken reasonable measures to protect the confidentiality of the information, and that it intends to continue to take such measures; (c) The information is not, and has not been, reasonably obtainable without the business' consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding); (d) No statute specifically requires disclosure of the information; and (e) Either-- (1) The information has been voluntarily submitted and the business has shown that it is of a kind that would not customarily be released to the public by the party from whom it was obtained; or (2) The information has not been voluntarily submitted and either-- (i) The business has satisfactorily shown that disclosure of the information is likely to cause substantial harm to the business' competitive position; or (ii) Disclosure of the information would be likely to impair the Government's ability to obtain necessary information in the future. Sec. 2.209 Disclosure in special circumstances. (a) General. Information which, under this subpart, is not available to the public may nonetheless be disclosed to the persons, and in the circumstances, described by paragraphs (b) through (g) of this section. (This section shall not be construed to restrict the disclosure of information which has been determined to be available to the public. However, business information for which a claim of confidentiality has been asserted shall be treated as being entitled to confidential treatment until there has been a determination in accordance with the procedures of this subpart that the information is not entitled to confidential treatment.) (b) Disclosure to Congress or the Comptroller General. (1) Upon receipt of a written request by the Speaker of the House, President of the Senate, chairman of a committee or subcommittee, or the Comptroller General, as appropriate, EPA will disclose business information to either House of Congress, to a committee or subcommittee of Congress, or to the Comptroller General, unless a statute forbids such disclosure. (2) If the request is for business information claimed as confidential or determined to be confidential, the EPA office processing the request shall provide notice to each affected business of the type of information disclosed and to whom it is disclosed. Notice shall be given at least ten days prior to disclosure, except where it is not possible to provide notice ten days in advance of any date established by the requesting body for responding to the request. Where ten days advance notice cannot be given, as much advance notice as possible shall be provided. Where notice cannot be given before the date established by the requesting body for responding to the request, notice shall be given as promptly after disclosure as possible. Such notice may be given by notice published in the Federal Register or by letter sent by certified mail, return receipt requested, or telegram. However, if the requesting body asks in writing that no notice under this subsection be given, EPA will give no notice. (3) At the time EPA discloses the business information, EPA will inform the requesting body of any unresolved business confidentiality claim known to cover the information and of any determination under this subpart that the information is entitled to confidential treatment. (c) Disclosure to other Federal agencies. EPA may disclose business information to another Federal agency if-- (1) EPA receives a written request for disclosures of the information from a duly authorized officer or employee of the other agency or on the initiative of EPA when such disclosure is necessary to enable the other agency to carry out a function on behalf of EPA; (2) The request, if any, sets forth the official purpose for which the information is needed; (3) When the information has been claimed as confidential or has been determined to be confidential, the responsible EPA office provides notice to each affected business of the type of information to be disclosed and to whom it is to be disclosed. At the discretion of the office, such notice may be given by notice published in the Federal Register at least 10 days prior to disclosure, or by letter sent by certified mail return receipt requested or telegram, either of which must be received by the affected business at least 10 days prior to disclosure. However, no notice shall be required when EPA furnishes business information to another Federal agency-- (i) To perform a function on behalf of EPA, including but not limited to-- (A) Disclosure to the Department of Justice for purposes of investigation or prosecution of civil or criminal violations of Federal law related to EPA activities; (B) Disclosure to the Department of Justice for purposes of representing EPA in any matter; and (C) Disclosure to any Federal agency for purposes of performing an EPA statutory function under an interagency agreement; or (ii) In connection with a law enforcement investigation by the other Federal agency; (4) EPA notifies the other agency of any unresolved business confidentiality claim covering the information and of any determination under this subpart that the information is entitled to confidential treatment, and that further disclosure of the information may be a violation of 18 U.S.C. 1905; and (5) The other agency agrees in writing not to disclose further any information designated as confidential unless-- (i) The other agency has statutory authority both to compel production of the information and to make the proposed disclosure, and the other agency has, prior to disclosure of the information to anyone other than its officers and employees, furnished to each affected business at least the same notice to which the affected business would be entitled under this subpart; (ii) The other agency has obtained the consent of each affected business to the proposed disclosure; or (iii) The other agency has obtained a written statement from the EPA General Counsel or an EPA Regional Counsel that disclosure of the information would be proper under this subpart. (d) Court-ordered disclosure. EPA may disclose any business information in any manner and to the extent ordered by a Federal court. Where possible, and when not in violation of a specific directive from the court, the EPA office disclosing information claimed as confidential or determined to be confidential shall provide as much advance notice as possible to each affected business of the type of information to be disclosed and to whom it is to be disclosed, unless the affected business has actual notice of the court order. At the discretion of the office, subject to any restrictions by the court, such notice may be given by notice in the Federal Register, letter sent by certified mail return receipt requested, or telegram. (e) Disclosure within EPA. An EPA office, officer, or employee may disclose any business information to another EPA office, officer, or employee with an official need for the information. (f) Disclosure with consent of business. EPA may disclose any business information to any person if EPA has obtained the prior consent of each affected business to such disclosure. (g) Disclosures to foreign governments and international organizations. (1) EPA may disclose business information to a foreign government or to an international organization if-- (i) Either-- (A) EPA receives a written request for disclosure of the information from a duly authorized officer or employee of the foreign government or international organization (or from a duly authorized officer or employee of another agency of the United States Government); or (B) The EPA office making such disclosure determines in writing that disclosure is necessary to enable the foreign government or international organization to assist EPA in carrying out a function of EPA, or to enable EPA to assist the foreign government or international organization with a duly-authorized function of that foreign government or international organization; (ii) The request, if any, sets forth the official purpose for which the information is needed; (iii) The General Counsel, after consideration of applicable statutes, treaties, and other international agreements, has determined that EPA has authority to make such disclosure; (iv) At least 10 days prior to disclosure, the responsible EPA office provides notice to each affected business by Federal Register, certified mail, return receipt requested, or other appropriate means of the type of information to be disclosed and to whom it is to be disclosed, and an opportunity to comment on the intended disclosure (except where the Director of the Office of Criminal Enforcement has determined that providing such notice would interfere with an ongoing or contemplated criminal investigation, or the Director of the Office of Regulatory Enforcement or a Regional Counsel has determined that providing such notice might compromise an ongoing or contemplated civil law enforcement investigation); (v) EPA notifies the foreign government or international organization of any unresolved business confidentiality claim covering the information and of any determination under this subpart that the information is entitled to confidential treatment; and (vi) The General Counsel has determined that the foreign government's or international organization's use and disclosure of such information will be governed by law and procedures or other binding commitments which will provide adequate protection to the interests of affected businesses. (2) The General Counsel may waive any requirement in this paragraph (g) if the General Counsel determines that a statute, treaty, or other international agreement prohibits EPA from implementing the requirement. (3) For purposes of this paragraph (g), the term foreign government means any foreign government or any department, agency, or other unit of a foreign government, and the term international organization means any public international organization, subdivision of a public international organization or public international organization preparatory commission, whether or not the United States is a member of the public international organization, the subdivision, or the preparatory commission in question. Sec. 2.210 Nondisclosure for reasons other than business confidentiality or where disclosure is prohibited by other statute. (a) Information which is not entitled to confidential treatment under this subpart shall be made available to the public (using the procedures set forth in Secs. 2.204 and 2.205) if its release is requested under 5 U.S.C. 552, unless EPA determines (under subpart A of this part) that, for reasons other than reasons of business confidentiality, the information is exempt from mandatory disclosure and cannot or should not be made available to the public. Any such determination under subpart A shall be coordinated with actions taken under this subpart for the purpose of avoiding delay in responding to requests under 5 U.S.C. 552. (b) Notwithstanding any other provision of this subpart, if any statute not cited in this subpart appears to require EPA to give confidential treatment to any business information for reasons of business confidentiality, the matter shall be referred promptly to an EPA legal office for resolution. Pending resolution, such information shall be treated as if it were entitled to confidential treatment. Sec. 2.211 Safeguarding of business information; penalty for wrongful disclosure. (a) No EPA officer or employee may disclose, or use for his or her private gain or advantage, any business information which came into his or her possession, or to which he or she gained access, by virtue of his or her official position or employment, except as authorized by this subpart. (b) Each EPA officer or employee who has custody or possession of business information shall take appropriate measures to properly safeguard such information and to protect against its improper disclosure. (c) Violation of paragraph (a) or (b) of this section shall constitute grounds for dismissal, suspension, or other adverse personnel action. Willful violation of paragraph (a) of this section may result in criminal prosecution under 18 U.S.C. 1905 or other applicable statute. (d) Each contractor or subcontractor with the United States Government, and each employee of such contractor or subcontractor, who is furnished business information by EPA under Secs. 2.301(h), 2.302(h), 2.304(h), 2.305(h), 2.306(j), 2.307(h), 2.308(i), or Sec. 2.310(h) shall use or disclose that information only as permitted by the contract or subcontract under which the information was furnished. Contractors or subcontractors shall take steps to properly safeguard business information including following any security procedures for handling and safeguarding business information which are contained in any manuals, procedures, regulations, or guidelines provided by EPA. Any violation of this paragraph shall constitute grounds for suspension or debarment of the contractor or subcontractor in question. A willful violation of this paragraph may result in criminal prosecution under an applicable statute. (e) Each grantee or cooperator under the Senior Environmental Employment Program (pursuant to the Environmental Programs Assistance Act of 1984 (Pub.L. 98-313)), and each enrollee associated with a grantee or cooperator, who is furnished business information by EPA under Secs. 2.301(h), 2.302(h), 2.304(h), 2.305(h), 2.307(h), 2.308(i), or Sec. 2.310(h) shall use or disclose that information only as permitted by the grant or cooperative agreement under which the information was furnished. Grantees, cooperators, and enrollees shall take steps to properly safeguard business information including following any security procedures for handling and safeguarding business information which are contained in any manuals, procedures, regulations, or guidelines provided by EPA. If an enrollee under the program violates this paragraph, EPA may terminate the enrollee's eligibility for the program. A willful violation of this paragraph may result in criminal prosecution under an applicable statute. Sec. 2.212 Establishment of control offices for categories of business information. (a) The Administrator, by order, may establish one or more mutually exclusive categories of business information, and may designate for each such category an EPA office (hereinafter referred to as a control office) which shall have responsibility for taking actions (other than actions required to be taken by an EPA legal office) with respect to all information within such category. (b) If a control office has been assigned responsibility for a category of business information, no other EPA office, officer, or employee may make available to the public (or otherwise disclose to persons other than EPA officers and employees) any information in that category without first obtaining the concurrence of the control office. Requests under 5 U.S.C. 552 for release of such information shall be referred to the control office. (c) A control office shall take the actions and make the determinations required by Sec. 2.204 with respect to all information in any category for which the control office has been assigned responsibility. (d) A control office shall maintain a record of the following, with respect to items of business information in categories for which it has been assigned responsibility: (1) Business confidentiality claims; (2) Comments submitted in support of claims; (3) Waivers and withdrawals of claims; (4) Actions and determinations by EPA under this subpart; (5) Actions by Federal courts; and (6) Related information concerning business confidentiality. Sec. 2.213 Designation by business of addressee for notices and inquiries. (a) A business which wishes to designate a person or office as the proper addressee of communications from EPA to the business under this subpart may do so by furnishing in writing to the Freedom of Information Officer (1105), Environmental Protection Agency, 401 M St. SW., Washington, DC 20460, the following information: The name and address of the business making the designation; the name, address, and telephone number of the designated person or office; and a request that EPA inquiries and communications (oral and written) under this subpart, including inquiries and notices which require reply within deadlines if the business is to avoid waiver of its rights under this subpart, be furnished to the designee pursuant to this section. Only one person or office may serve at any one time as a business' designee under this subpart. (b) If a business has named a designee under this section, the following EPA inquiries and notices to the business shall be addressed to the designee: (1) Inquiries concerning a business' desire to assert a business confidentiality claim under Sec. 2.204(c)(2)(i)(A); (2) Notices affording opportunity to substantiate confidentiality claims under Sec. 2.204(d)(1) and Sec. 2.204(e); (3) Inquires concerning comments under Sec. 2.205(b)(4); (4) Notices of denial of confidential treatment and proposed disclosure of information under Sec. 2.205(f); (5) Notices concerning shortened comment and/or waiting periods under Sec. 2.205(g); (6) Notices concerning modifications or overrulings of prior determinations under Sec. 2.205(h); (7) Notices to affected businesses under Secs. 2.301(g) and 2.301(h) and analogous provisions in Secs. 2.302, 2.303, 2.304, 2.305, 2.306, 2.307, 2.308 and 2.310; and (8) Notices to affected businesses under Sec. 2.209. (c) The Freedom of Information Officer shall, as quickly as possible, notify all EPA offices that may possess information submitted by the business to EPA, the Regional Freedom of Information Offices, the Office of General Counsel, and the offices of Regional Counsel of any designation received under this section. Businesses making designations under this section should mind that several working days may be required for dissemination of this information within EPA and that some EPA offices may not receive notice of such designations. Sec. 2.214 Defense of Freedom of Information Act suits; participation by affected business. (a) In making final confidentiality determinations under this subpart, the EPA legal office relies to a large extent upon the information furnished by the affected business to substantiate its claim of confidentiality. The EPA legal office may be unable to verify the accuracy of much of the information submitted by the affected business. (b) If the EPA legal office makes a final confidentiality determination under this subpart that certain business information is entitled to confidential treatment, and EPA is sued by a requester under the Freedom of Information Act for disclosure of that information, EPA will: (1) Notify each affected business of the suit within 10 days after service of the complaint upon EPA; (2) Where necessary to preparation of EPA's defense, call upon each affected business to furnish assistance; and (3) Not oppose a motion by any affected business to intervene as a party to the suit under rule 24(b) of the Federal Rules of Civil Procedure. (c) EPA will defend its final confidentiality determination, but EPA expects the affected business to cooperate to the fullest extent possible in this defense. Sec. 2.215 Confidentiality agreements. (a) No EPA officer, employee, contractor, or subcontractor shall enter into any agreement with any affected business to keep business information confidential unless such agreement is consistent with this subpart. No EPA officer, employee, contractor, or subcontractor shall promise any affected business that business information will be kept confidential unless the promise is consistent with this subpart. (b) If an EPA office has requested information from a State, local, or Federal agency and the agency refuses to furnish the information to EPA because the information is or may constitute confidential business information, the EPA office may enter into an agreement with the agency to keep the information confidential, notwithstanding the provisions of this subpart. However, no such agreement shall be made unless the General Counsel determines that the agreement is necessary and proper. (c) To determine that an agreement proposed under paragraph (b) of this section is necessary, the General Counsel must find: (1) The EPA office requesting the information needs the information to perform its functions; (2) The agency will not furnish the information to EPA without an agreement by EPA to keep the information confidential; and (3) Either: (i) EPA has no statutory power to compel submission of the information directly from the affected business, or (ii) While EPA has statutory power to compel submission of the information directly from the affected business, compelling submission of the information directly from the business would-- (A) Require time in excess of that available to the EPA office to perform its necessary work with the information, (B) Duplicate information already collected by the other agency and overly burden the affected business, or (C) Overly burden the resources of EPA. (d) To determine that an agreement proposed under paragraph (b) of this section is proper, the General Counsel must find that the agreement states-- (1) The purpose for which the information is required by EPA; (2) The conditions under which the agency will furnish the information to EPA; (3) The information subject to the agreement; (4) That the agreement does not cover information acquired by EPA from another source; (5) The manner in which EPA will treat the information; and (6) That EPA will treat the information in accordance with the agreement subject to an order of a Federal court to disclose the information. (e) EPA will treat any information acquired pursuant to an agreement under paragraph (b) of this section in accordance with the procedures of this subpart except where the agreement specifies otherwise. Sec. 2.216 Sunset Provisions for Confidentiality Claims. (a) Any claim of confidentiality asserted under this subpart will expire if-- (1) The claim is subject to a regulation meeting the requirements of paragraph (b) of this section; (2) No affected business has met the requirements of paragraphs (c) and (d) of this section during the period of time specified in paragraph (c) of this section; and (3) The sunset period or event set by the regulation referred to in paragraph (a)(1) of this section has passed or occurred. (b) Any regulation which causes a confidentiality claim to expire must specify-- (1) The class of information subject to the sunset provision; and (2) The period of time which must pass or the event which must occur to cause the confidentiality claim to expire. (c) A claim of confidentiality subject to a regulation meeting the requirements of paragraph (b) of this section will not expire if an affected business reasserts the confidentiality claim within 90 calendar days prior to the expiration of the period, or within 90 days subsequent to the occurrence of the event, set forth in paragraph (b) of this section. A regulation under paragraph (b) of this section may provide for a reassertion period of less than 90 days. (d) An officer of the affected business must sign the reassertion of confidentiality submitted pursuant to paragraph (c) of this section and must certify to the truth of the following statements concerning the information reasserted to be confidential: (1) My company has continually taken measures to protect the confidentiality of the information, and intends to continue to take such measures. (2) The information is not, and has not been, reasonably obtainable without our consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding). (3) The information is not publicly available elsewhere. (4) If the information was not submitted voluntarily to EPA, disclosure of the information would cause substantial harm to our competitive position. (e) A confidentiality claim which has expired pursuant to paragraph (a) of this section is deemed waived, and the information subject to that claim may be disclosed to the public without further notice to the affected business. Sec. 2.217-2.300 [Reserved] Sec. 2.301 Special rules governing certain information obtained under the Clean Air Act. (a) Definitions. For the purpose of this section: (1) Act means the Clean Air Act, as amended, 42 U.S.C. 7401 et seq. (2)(i) Emission data means, with reference to any source of emission of any substance into the air-- (A) Information necessary to determine the identity, amount, frequency, concentration, or other characteristics (to the extent related to air quality) of any emission which has been emitted by the source (or of any pollutant resulting from any emission by the source), or any combination of the foregoing; (B) Information necessary to determine the identity, amount, frequency, concentration, or other characteristics (to the extent related to air quality) of the emissions which, under an applicable standard or limitation, the source was authorized to emit (including, to the extent necessary for such purposes, a description of the manner or rate of operation of the source); and (C) A general description of the location and/or nature of the source to the extent necessary to identify the source and to distinguish it from other sources (including, to the extent necessary for such purposes, a description of the device, installation, or operation constituting the source). (ii) Notwithstanding paragraph (a)(2)(i) of this section, the following information shall be considered to be emission data only to the extent necessary to allow EPA to disclose publicly that a source is (or is not) in compliance with an applicable standard or limitation, or to allow EPA to demonstrate the feasibility, practicability, or attainability (or lack thereof) of an existing or proposed standard or limitation: (A) Information concerning research, or the results of research, on any project, method, device or installation (or any component thereof) which was produced, developed, installed, and used only for research purposes; and (B) Information concerning any product, method, device, or installation (or any component thereof) designed and intended to be marketed or used commercially but not yet so marketed or used. (3) Standard or limitation means any emission standard or limitation (including a standard or limitation that must be disclosed under subchapter VI of the Act in connection with allocation of production and consumption allowances for ozone depleting substances) established or publicly proposed pursuant to the Act or pursuant to any regulation under the Act. (4) Proceeding means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act, except for determinations under this subpart. (5) Manufacturer has the meaning given it in section 216(1) of the Act, 42 U.S.C. 7550(1). (b) Applicability. (1) This section applies to business information which was-- (i) Provided or obtained under section 114 of the Act, 42 U.S.C. 7414, by the owner or operator of any stationary source, for the purpose: (A) of developing or assisting in the development of any implementation plan under section 110 or 111(d) of the Act, 42 U.S.C. 7410, 7411(d), any standard of performance under section 111 of the Act, 42 U.S.C. 7411, or any emission standard under section 112 of the Act, 42 U.S.C. 7412; (B) of determining whether any person is in violation of any such standard or any requirement of such a plan; or (C) of carrying out any provision of the Act (except a provision of Part II of the Act with respect to a manufacturer of new motor vehicles or new motor vehicle engines); (ii) Provided or obtained under section 208 of the Act, 42 U.S.C. 7542, for the purpose of enabling the Administrator to determine whether a manufacturer has acted or is acting in compliance with part A and part C of Subchapter II of the Act and regulations thereunder, or to otherwise carry out the provisions of part A and part C of Subchapter II of the Act, or provided or obtained under section 206(c) of the Act, 42 U.S.C. 7525(c); or (iii) Provided in response to a subpoena for the production of papers, books, or documents issued under the authority of section 307(a) of the Act, 42 U.S.C. 7607(a). (2) Information will be considered to have been provided or obtained under section 114 of the Act if it was provided in response to a request by EPA made for any of the purposes stated in section 114, or if its submission could have been required under section 114, regardless of whether section 114 was cited as the authority for any request for the information, whether an order to provide the information was issued under section 113(a) of the Act, 42 U.S.C. 7413(a), whether an action was brought under section 113(b) of the Act, 42 U.S.C. 7413(b), or whether the information was provided directly to EPA or through some third person. (3) Information will be considered to have been provided or obtained under section 208 of the Act if it was provided in response to a request by EPA made for any of the purposes stated in section 208, or if its submission could have been required under section 208, regardless of whether section 208 was cited as the authority for any request for the information, whether an action was brought under section 204 of the Act, 42 U.S.C. 7523, or whether the information was provided directly to EPA or through some third person. (4) Information will be considered to have been provided or obtained under section 206(c) of the Act if it was provided in response to a request by EPA made for any of the purposes stated in section 206(c), or if its submission could have been required under section 206(c) regardless of whether section 206(c) was cited as authority for any request for the information, whether an action was brought under section 204 of the Act, 42 U.S.C. 7523, or whether the information was provided directly to EPA or through some third person. (5) Information will be considered to have been provided or obtained under section 307(a) of the Act if it was provided in response to a subpoena issued under section 307(a), or if its production could have been required by subpoena under section 307(a), regardless of whether section 307(a) was cited as the authority for any request for the information, whether a subpoena was issued by EPA, whether a court issued an order under section 307(a), or whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201, 2.202, 2.204 through 2.207, Sec. 2.209 and Sec. Sec. 2.211 through 2.216 apply without change to information to which this section applies. (d) Section 2.203 applies to information to which this section applies, except that: (1) Information submitted pursuant to 40 CFR part 57, Primary Nonferrous Smelter Orders, shall be subject to the requirements of Sec. 57.203(a) and Appendix A of this chapter, instruction 1.3; (2) Information submitted pursuant to 40 CFR part 85, Control of Air Pollution from Motor Vehicles and Motor Vehicle Engines, shall be subject to the requirements of Secs. 85.1514, 85.1712, 85.1808, 85.1909, 85.2123, and 85.408 of this chapter; and (3) Information submitted pursuant to 40 CFR part 86, Control of Air Pollution from New and In-Use Motor Vehicles and New and In-Use Motor Vehicle Engines: Certification and Test Procedures, shall be subject to the requirements of Secs. 86.1015, 86.1116-87 and 86.615-84 of this chapter. (e) Substantive criteria for use in confidentiality determinations. (1) Section 2.208 applies to information to which this section applies, except that information which is emission data, a standard or limitation (including a standard or limitation that must be disclosed under subchapter VI of the Act in connection with allocation of production and consumption allowances for ozone depleting substances), or is collected pursuant to section 211(b)(2)(A) of the Act is not eligible for confidential treatment. (2) The following information, when submitted pursuant to a request for information under section 114 of the Act, constitutes emission data (but is not an exhaustive list of information which is emission data) and, notwithstanding any claims of confidentiality, may be disclosed to the public without notice to affected businesses: (i) Plant name and related point identifiers, including address, city, county, Air Quality Control Region (AQCR), Metropolitan Statistical Area (MSA, PMSA, CMSA), State, zip code; (ii) Ownership and point of contact information locational identifiers, including latitude and longitude, or Universal Transverse Mercator (UTM) grid coordinates, standard industrial classification (SIC), emission point, device or operation description information, and source classification codes (SCC); and (iii) Emissions parameters, including emission type, emission rate, release height, description of terrain and surrounding structures, stack or vent diameter at point of emissions, release velocity, release temperature, frequency of release, duration of release, concentration, density of emissions stream or average molecular weight, boiler or process design capacity, emission estimation method, percent space heat, and hourly maximum design rate. (f) Availability of information not entitled to confidential treatment. Section 2.210 does not apply to information to which this section applies. Emission data, standards or limitations, and any other information provided under section 114 or 208 of the Act which is determined under this subpart not to be entitled to confidential treatment, shall be available to the public notwithstanding any other provision of this part. Emission data and standards or limitations provided in response to a subpoena issued under section 307(a) of the Act shall be available to the public notwithstanding any other provision of this part. Information (other than emission data and standards or limitations) provided in response to a subpoena issued under section 307(a) of the Act, which is determined under this subpart not to be entitled to confidential treatment, shall be available to the public, unless EPA determines that the information is exempt from mandatory disclosure under 5 U.S.C. 552(b) for reasons other than reasons of business confidentiality and cannot or should not be made available to the public. (g) Disclosure of information relevant to a proceeding. (1) Under sections 114, 208 and 307 of the Act, any information to which this section applies may be released by EPA because of the relevance of the information to a proceeding, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information because of its relevance to a proceeding shall be made only in accordance with this paragraph (g). (2) In connection with any proceeding other than a proceeding involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, information to which this section applies which may be entitled to confidential treatment may be made available to the public under this paragraph (g)(2). No information shall be made available to the public under this paragraph (g)(2) until any affected business has been informed that EPA is considering making the information available to the public under this paragraph (g)(2) in connection with an identified proceeding, and has afforded the business a reasonable period for comment (such notice and opportunity to comment may be afforded in connection with the notice prescribed by Secs. 2.204(d)(1) and 2.204(e)). Information may be made available to the public under this paragraph (g)(2) only if, after consideration of any timely comments submitted by the business, the General Counsel determines that the information is relevant to the subject of the proceeding and the EPA office conducting the proceeding determines that the public interest would be served by making the information available to the public. Any affected business shall be given at least 5 days notice by the General Counsel prior to making the information available to the public. (3) In connection with any proceeding involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, information to which this section applies which may be entitled to confidential treatment may be made available to the public, or to one or more parties of record to the proceeding, upon EPA's initiative, under this paragraph (g)(3). An EPA office proposing disclosure of information under this paragraph (g)(3), shall so notify the presiding officer in writing. Upon receipt of such a notification, the presiding officer shall notify each affected business that disclosure under this paragraph (g)(3) has been proposed, and shall afford each such business a period for comment found by the presiding officer to be reasonable under the circumstances. Information may be disclosed under this paragraph (g)(3) only if, after consideration of any timely comments submitted by the business, the EPA office determines in writing that, for reasons directly associated with the conduct of the proceeding, the contemplated disclosure would serve the public interest, and the presiding officer determines in writing that the information is relevant to a matter in controversy in the proceeding. The presiding officer may condition disclosure of the information to a party of record on the making of such protective arrangements and commitments as the presiding officer finds to be warranted. Disclosure to one or more parties of record, under protective arrangements or commitments, shall not, of itself, affect the eligibility of information for confidential treatment under the other provisions of this subpart. Any affected business shall be given at least 5 days notice by the presiding officer prior to making the information available to the public or to one or more of the parties of record to the proceeding. (4) In connection with any proceeding involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, information to which this section applies may be made available to one or more parties of record to the proceeding, upon request of a party, under this paragraph (g)(4). A party of record seeking disclosure of information shall direct its request to the presiding officer. Upon receipt of such a request, the presiding officer shall notify each affected business that disclosure under this paragraph (g)(4) has been requested, and shall afford each such business a period for comment found by the presiding officer to be reasonable under the circumstances. Information may be disclosed to a party of record under this paragraph (g)(4) only if, after consideration of any timely comments submitted by the business, the presiding officer determines in writing that: the party of record has satisfactorily shown that with respect to a significant matter which is in controversy in the proceeding, the party's ability to participate effectively in the proceeding will be significantly impaired unless the information is disclosed to him; and any harm to an affected business that would result from the disclosure is likely to be outweighed by the benefit to the proceeding and to the public interest that would result from the disclosure. The presiding officer may condition disclosure of the information to a party of record on the making of such protective arrangements and commitments as he finds to be warranted. Disclosure to one or more parties of record, under protective arrangements or commitments, shall not, of itself, affect the eligibility of information to confidential treatment under the other provisions of this subpart. Any affected business shall be given at least 5 days notice by the presiding officer prior to making the information available to one or more of the parties of record to the proceeding. (h) Disclosure to authorized representatives. (1) Under sections 114, 208 and 307(a) of the Act, EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information might otherwise be entitled to confidential treatment under this subpart. Such authority may be exercised only in accordance with paragraph (h) (2) or (3) of this section. (2)(i) A person under contract or subcontract to the United States Government to perform work in support of EPA in connection with the Act or regulations which implement the Act may be considered an authorized representative of the United States for purposes of this paragraph (h). For purposes of this section, the term ``contract'' includes grants and cooperative agreements under the Environmental Programs Assistance Act of 1984 (Pub. L. 98-313), and the term ``contractor'' includes grantees and cooperators under the Environmental Programs Assistance Act of 1984. Subject to the limitations in this paragraph (h)(2), information to which this section applies may be disclosed-- (A) To a contractor or subcontractor with EPA, if the EPA program office managing the contract first determines in writing that such disclosure is necessary in order that the contractor or subcontractor may carry out the work required by the contract or subcontract; or (B) To a contractor or subcontractor with an agency other than EPA, if the EPA program office which provides the information to that agency, contractor, or subcontractor first determines in writing, in consultation with the General Counsel, that such disclosure is necessary in order that the contractor or subcontractor may carry out the work required by the contract or subcontract. (ii) No information shall be disclosed under this paragraph (h)(2), unless this contract or subcontract in question provides: (A) That the contractor or subcontractor and the contractor's or subcontractor's employees shall use the information only for the purpose of carrying out the work required by the contract or subcontract, shall refrain from disclosing the information to anyone other than EPA without the prior written approval of each affected business or of an EPA legal office, and shall return to EPA all copies of the information (and any abstracts or extracts therefrom) upon request by the EPA program office whenever the information is no longer required by the contractor or subcontractor for the performance of the work required under the contract or subcontract or upon completion of the contract or subcontract (where the information was provided to the contractor or subcontractor by an agency other than EPA, the contractor may disclose or return the information to that agency); (B) That the contractor or subcontractor shall obtain a written agreement to honor such terms of the contract or subcontract from each of the contractor's or subcontractor's employees who will have access to the information, before such employee is allowed such access; and (C) That the contractor or subcontractor acknowledges and agrees that the contract or subcontract provisions concerning the use and disclosure of business information are included for the benefit of, and shall be enforceable by, both the United States Government and any affected business having an interest in information concerning it supplied to the contractor or subcontractor by the United States Government under the contract or subcontract. (iii) No information shall be disclosed under this paragraph (h)(2) until each affected business has been furnished notice (by letter, Federal Register, or other means) of the contemplated disclosure by the EPA program and has been afforded a period found reasonable by that office (not less than 5 working days) to submit its comments. Such notice shall include a description of the information to be disclosed, the identity of the contractor or subcontractor, and the purposes to be served by the disclosure. The office preparing the notice must respond in writing to all comments. (3) A State or local governmental agency which has duties or responsibilities under the Act, or under regulations which implement the Act, may be considered an authorized representative of the United States for purposes of this paragraph (h). Information to which this section applies may be furnished to such an agency at the agency's written request, but only if-- (i) The agency has first furnished to the EPA office having custody of the information a written opinion from the agency's chief legal officer or counsel stating that under applicable State or local law the agency has the authority to compel a business which possesses such information to disclose it to the agency; or (ii) Each affected business is informed (by letter, Federal Register, or other means) of those disclosures under this paragraph (h)(3) which pertain to it, and the agency has shown to the satisfaction of an EPA legal office that the agency's use and disclosure of such information will be governed by State or local law and procedures which will provide adequate protection to the interests of affected businesses. Sec. 2.302 Special rules governing certain information obtained under the Clean Water Act. (a) Definitions. For the purposes of this section: (1) Act means the Clean Water Act, as amended, 33 U.S.C. 1251 et seq. (2)(i) Effluent data means, with reference to any source of discharge of any pollutant (as that term is defined in section 502(6) of the Act, 33 U.S.C. 1362 (6))-- (A) Information necessary to determine the identity, amount, frequency, concentration, temperature, or other characteristics (to the extent related to water quality) of any pollutant which has been discharged by the source (or of any pollutant resulting from any discharge from the source), or any combination of the foregoing; (B) Information necessary to determine the identity, amount, frequency, concentration, temperature, or other characteristics (to the extent related to water quality) of the pollutants which, under an applicable standard or limitation, the source was authorized to discharge (including, to the extent necessary for such purpose, a description of the manner or rate of operation of the source); and (C) A general description of the location and/or nature of the source to the extent necessary to identify the source and to distinguish it from other sources (including, to the extent necessary for such purposes, a description of the device, installation, or operation constituting the source). (ii) Notwithstanding paragraph (a)(2)(i) of this section, the following information shall be considered to be effluent data only to the extent necessary to allow EPA to disclose publicly that a source is (or is not) in compliance with an applicable standard or limitation, or to allow EPA to demonstrate the feasibility, practicability, or attainability (or lack thereof) of an existing or proposed standard or limitation: (A) Information concerning research, or the results of research, on any product, method, device, or installation (or any component thereof) which was produced, developed, installed, and used only for research purposes; and (B) Information concerning any product, method, device, or installation (or any component thereof) designed and intended to be marketed or used commercially but not yet so marketed or used. (3) Standard or limitation means any prohibition, any effluent limitation, or any toxic, pre-treatment or new source performance standard established or publicly proposed pursuant to the Act or pursuant to regulations under the Act, including limitations or prohibitions in a permit issued or proposed by EPA or by a State under section 402 of the Act, 33 U.S.C. 1342. (4) Proceeding means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act, except for determinations under this part. (b) Applicability. (1) This section applies only to business information-- (i) Provided to or obtained by EPA under section 308 of the Act, 33 U.S.C. 1318, by or from the owner or operator of any point source, for the purpose of carrying out the objective of the Act (including but not limited to developing or assisting in the development of any standard or limitation under the Act, or in determining whether any person is in violation of any such standard or limitation); or (ii) Provided to or obtained by EPA under section 509(a) of the Act, 33 U.S.C. 1369(a). (2) Information will be considered to have been provided or obtained under section 308 of the Act if it was provided in response to a request by EPA made for any of the purposes stated in section 308, or if its submission could have been required under section 308, regardless of whether section 308 was cited as the authority for any request for the information, whether an order to provide the information was issued under section 309(a)(3) of the Act, 33 U.S.C. 1319(a)(3), whether a civil action was brought under section 309(b) of the Act, 33 U.S.C. 1319(b), and whether the information was provided directly to EPA or through some third person. (3) Information will be considered to have been provided or obtained under section 509(a) of the Act if it was provided in response to a subpoena issued under section 509(a), or if its production could have been required by subpoena under section 509(a), regardless of whether section 509(a) was cited as the authority for any request for the information, whether a subpoena was issued by EPA, whether a court issued an order under section 307(a), or whether the information was provided directly to EPA or through some third person. (4) This section specifically does not apply to information obtained under section 310(d) or 312(g)(3) of the Act, 33 U.S.C. 1320(d), 1322(g)(3). (c) Basic rules which apply without change. Sections 2.201 through 2.207, 2.209, 2.211 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) Substantive criteria for use in confidentiality determinations. Section 2.208 applies to information to which this section applies, except that the following information is not eligible for confidential treatment: (1) Information which is effluent data or a standard or limitation; (2) Name and address of any permit applicant or permittee under part 122 of this chapter, part 501 of this chapter, or Section 404 of the Act; and (3) Any permit application (including any attachments used to supply information required by the applications forms) or permit under part 122 of this chapter, part 501 of this chapter, or Section 404 of the Act. (f) Availability of information not entitled to confidential treatment. Section 2.210 does not apply to information to which this section applies. Effluent data, standards or limitations, or any other information provided or obtained under section 308 of the Act which is determined under this subpart not to be entitled to confidential treatment, shall be available to the public notwithstanding any other provision of this part. Effluent data and standards or limitations provided in response to a subpoena issued under section 509(a) of the Act shall be available to the public notwithstanding any other provision of this part. Information (other than effluent data and standards or limitations) provided in response to a subpoena issued under section 509(a) of the Act, which is determined under this subpart not to be entitled to confidential treatment, shall be available to the public, unless EPA determines that the information is exempt from mandatory disclosure under 5 U.S.C. 552(b) for reasons other than reasons of business confidentiality and cannot or should not be made available to the public. (g) Disclosure of information relevant to a proceeding. (1) Under sections 308 and 509(a) of the Act, any information to which this section applies may be released by EPA because of the relevance of the information to a proceeding, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information to which this section applies because of its relevance to a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be followed when making disclosures pursuant to this paragraph (g). (h) Disclosure to authorized representatives. (1) Under sections 308 and 509(a) of the Act, EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information might otherwise be entitled to confidential treatment under this subpart. Such authority may be exercised only in accordance with paragraph (h)(2) or (h)(3) of this section. (2) The provisions of Sec. 2.301(h) (2) and (3) must be followed when making disclosures pursuant to this paragraph (h). Sec. 2.303 Special rules governing certain information obtained under the Noise Control Act of 1972. (a) Definitions. For the purposes of this section: (1) Act means the Noise Control Act of 1972, 42 U.S.C. 4901 et seq. (2) Manufacturer has the meaning given it in 42 U.S.C. 4902(6). (3) Product has the meaning given it in 42 U.S.C. 4902(3). (4) Proceeding means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act, except for determinations under this subpart. (b) Applicability. This section applies only to information provided to or obtained by EPA under section 13 of the Act, 42 U.S.C. 4912, by or from any manufacturer of any product to which regulations under section 6 or 8 of the Act (42 U.S.C. 4905, 4907) apply. Information will be deemed to have been provided or obtained under section 13 of the Act, if it was provided in response to a request by EPA made for the purpose of enabling EPA to determine whether the manufacturer has acted or is acting in compliance with the Act, or if its submission could have been required under section 13 of the Act regardless of whether section 13 was cited as authority for the request, whether an order to provide such information was issued under section 11(d) of the Act, 42 U.S.C. 4910(d), and whether the information was provided directly to EPA by the manufacturer or through some third person. (c) Basic rules which apply without change. Sections 2.201 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) [Reserved] (f) [Reserved] (g) Disclosure of information relevant to a proceeding. (1) Under section 13 of the Act, any information to which this section applies may be released by EPA because of its relevance to a matter in controversy in a proceeding, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information because of its relevance to a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be followed when making disclosures pursuant to this paragraph (g). Sec. 2.304 Special rules governing certain information obtained under the Safe Drinking Water Act. (a) Definitions. For the purposes of this section: (1) Act means the Safe Drinking Water Act, 42 U.S.C. 300f et seq. (2) Contaminant means any physical, chemical, biological, or radiological substance or matter in water. (3) Proceeding means any rulemaking, adjudication, or licensing process conducted by EPA under the Act or under regulations which implement the Act, except for any determination under this part. (b) Applicability. (1) This section applies only to information-- (i) Which was provided to or obtained by EPA pursuant to a requirement of a regulation which was issued by EPA under the Act for the purpose of-- (A) Assisting the Administrator in establishing regulations under the Act; (B) Determining whether the person providing the information has acted or is acting in compliance with the Act; or (C) Administering any program of financial assistance under the Act; and (ii) Which was provided by a person-- (A) Who is a supplier of water, as defined in section 1401(5) of the Act, 42 U.S.C. 300f(5); (B) Who is or may be subject to a primary drinking water regulation under section 1412 of the Act, 42 U.S.C. P300g-1; (C) Who is or may be subject to an applicable underground injection control program, as defined in section 1422(d) of the Act, 42 U.S.C.300h-1(d); (D) Who is or may be subject to the permit requirements of section 1424(b) of the Act, 42 U.S.C. 300h-3(b); (E) Who is or may be subject to an order issued under section 1441(c) of the Act, 42 U.S.C. 300j(c); or (F) Who is a grantee, as defined in section 1445(e) of the Act, 42 U.S.C. 300j-4(e). (2) This section applies to any information which is described by paragraph (b)(1) of this section if it was provided in response to a request by EPA or its authorized representative (or by a State agency administering any program under the Act) made for any purpose stated in paragraph (b)(1) of this section, or if its submission could have been required under section 1445 of the Act, 42 U.S.C. 300j-4, regardless of whether such section was cited in any request for the information, or whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201 through 2.207, 2.209, and 2.211 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) Substantive criteria for use in confidentiality determinations. Section 2.208 applies to information to which this section applies, except that the following information is not eligible for confidential treatment: the name and address of any permit applicant or permittee and information which pertains to the existence, absence, or level of contaminants in drinking water is not eligible for confidential treatment. (f) Nondisclosure for reasons other than business confidentiality or where disclosure is prohibited by other statute. Section 2.210 applies to information to which this section applies, except that information which deals with the existence, absence, or level of contaminants in drinking water shall be available to the public notwithstanding any other provision of this part. (g) Disclosure of information relevant to a proceeding. (1) Under section 1445(d) of the Act, any information to which this section applies may be released by EPA because of the relevance of the information to a proceeding, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information to which this section applies because of its relevance to a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be followed when making disclosures pursuant to this paragraph (g). (h) Disclosure to authorized representatives. (1) Under section 1445(d) of the Act, EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Such authority may be exercised only in accordance with paragraph (h)(2) of this section. (2) The provisions of Sec. 2.301(h) (2) and (3) must be followed when making disclsoures pursuant to this paragraph (h). Sec. 2.305 Special rules governing certain information obtained under the Solid Waste Disposal Act, as amended. (a) Definitions. For purposes of this section: (1) Act means the Solid Waste Disposal Act, as amended, including amendments made by the Resource Conservation and Recovery Act of 1976, as amended, 42 U.S.C. 6901 et seq. (2) Person has the meaning given it in section 1004(15) of the Act, 42 U.S.C. 6903(15). (3) Hazardous waste has the meaning given it in section 1004(5) of the Act, 42 U.S.C. 6903(5). (4) Proceeding means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act including the issuance of administrative orders and the approval or disapproval of plans (e.g. closure plans) submitted by persons subject to regulation under the Act, but not including determinations under this subpart. (b) Applicability. This section applies to information provided to or obtained by EPA under section 3001(b)(3)(B), 3007, or 9005 of the Act, 42 U.S.C 6921(b)(3)(B), 6927, or 6991d. Information will be considered to have been provided or obtained under sections 3001(b)(3)(B), 3007, or 9005 of the Act if it was provided in response to a request from EPA made for any of the purposes stated in the Act or if its submission could have been required under those provisions of the Act regardless of whether a specific section was cited as the authority for any request for the information or whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) [Reserved] (f) Disclosure of hazardous waste export information. Information that is required by 40 CFR 262.53(a) which is submitted in notification 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. (g) Disclosure of information relevant in a proceeding. (1) Under sections 3007(b) and 9005(b) of the Act (42 U.S.C. 6927(b) and 6991d(b)), any information to which this section applies may be disclosed by EPA because of the relevance of the information in a proceeding under the Act, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Disclosure of information to which this section applies because of its relevance in a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be followed when making disclosures pursuant to this paragraph (g). (h) Disclosure to authorized representatives. (1) Under sections 3001(b)(3)(B), 3007(b), and 9005(b) of the Act (42 U.S.C. 6921(b)(3)(B), 6927(b), and 6991d(b)), EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information might otherwise be entitled to confidential treatment under this subpart. Such authority may be exercised only in accordance with paragraph (h)(2) or (h)(3) of this section. (2) The provisions of Sec. 2.301(h) (2) and (3) must be followed when making disclosures pursuant to this paragraph (h). (3) At the time any information is furnished to a contractor, subcontractor, or State or local government agency under this paragraph (h), the EPA office furnishing the information to the contractor, subcontractor, or State or local government agency shall notify the contractor, subcontractor, or State or local government agency that the information may be entitled to confidential treatment and that any knowing and willful disclosure of the information may subject the contractor, subcontractor, or State or local government agency and its employees to penalties in section 3001(b)(3)(B), 3007(b)(2), or 9005(b)(1) of the Act (42 U.S.C. 6921(b)(3)(B), 6927(b), or 6991d(b)). Sec. 2.306 Special rules governing certain information obtained under the Toxic Substances Control Act. (a) Definitions. For the purposes of this section: (1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. (2) Chemical substance has the meaning given it in section 3(2) of the Act, 15 U.S.C. 2602(2). (3) Health and safety data (sometimes referred to in this section as health and safety study) means the information described in paragraphs (a)(3) (i), (ii), and (iii) of this section with respect to any chemical substance or mixture offered for commercial distribution (including for test marketing purposes and for use in research and development), including but not limited to any chemical substance included on the inventory of chemical substances under section 8 of the Act (15 U.S.C. 2607), or any chemical substance or mixture for which testing is required under section 4 of the Act (15 U.S.C. 2603) or for which notification is required under section 5 of the Act (15 U.S.C. 2604). (i) Any study of any effect of a chemical substance or mixture on health, on the environment, or on both, including underlying data and epidemiological studies; studies of occupational exposure to a chemical substance or mixture; and toxicological, clinical, and ecological studies of a chemical substance or mixture; (ii) Any test performed under the Act; and (iii) Any data reported to, or otherwise obtained by, EPA from a study described in paragraph (a)(3)(i) of this section or a test described in paragraph (a)(3)(ii) of this section. It is intended that the term ``health and safety study'' be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or environment would be included. Chemical identity is part of, or underlying data to, a health and safety study. (4) [Reserved] (5) Mixture has the meaning given it in section 3(8) of the Act, 15 U.S.C. 2602(8). (6) Proceeding means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act, except for determinations under this subpart. (7) Senior Management Official means an official with management responsibilities for the affected business, such as officials with management responsibilities for the person or persons completing the report, or the manager of environmental programs for the facility or establishments, or for the corporation owning or operating the facility or establishment responsible for certifying similar reports under other environmental regulatory requirements. (8) TSCA Inventory means EPA's comprehensive list of chemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes substances reported under 40 CFR part 710, subpart A and substances reported under 40 CFR part 720 for which a Notice of Commencement of Manufacture or Import has been received under 40 CFR 720.120. (b) Applicability. This section applies to all information submitted to EPA for the purpose of satisfying some requirement or condition of the Act or of regulations which implement the Act, including information originally submitted to EPA for some other purpose and either relied upon to avoid some requirement or condition of the Act or incorporated into a submission in order to satisfy some requirement or condition of the Act or of regulations which implement the Act. Information will be considered to have been provided under the Act if the information could have been obtained under authority of the Act, whether the Act was cited as authority or not, and whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201, 2.202, 2.206, 2.207, and Secs. 2.210 through 2.216 apply without change to information to which this section applies. (d) Method of asserting business confidentiality claim; effect of failure to assert claim at time of submission. Section 2.203 applies, except that-- (1) An owner, operator or senior management official, as defined in paragraph (a)(7) of this section, shall sign all business confidentiality claims to which this section applies; (2) With respect to confidentiality claims for specific chemical identity in submissions of Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment in accordance with section 8(c) of the Act and 40 CFR part 717, Health and Safety Data Reports in accordance with section 8(d) of the Act and 40 CFR part 716, or notices of substantial risk in accordance with section 8(e) of the Act, where the chemical substance is listed on the TSCA Inventory-- (i) The affected business must file with the document submission detailed written answers to the following 11 questions signed and dated by a senior management official, as defined in paragraph (a)(7) of this section: (A) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this subpart? (B) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why? (C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential? (D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone? (E) Is the fact that the chemical substance is being manufactured or imported for a commercial purpose publicly available, for example in technical journals, libraries, or State, local, or Federal agency public files? (F) What measures have you taken to prevent undesired disclosure of the fact that this chemical substance is being manufactured or imported for a commercial purpose? (G) To what extent has the fact that this chemical substance is manufactured or imported for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors? (H) Does this particular chemical substance leave the site of manufacture in any form, as product, effluent, emission, etc.? If so, what measures have you taken to guard against discovery of its identity? (I) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product? (J) For what purpose do you manufacture or import the substance? (K) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations. (ii) If any of the information contained in the answers to the questions is asserted to contain confidential business information, the submitter must mark that information as ``trade secret,'' ``confidential'' or other appropriate designation. (iii) If the substantiation required under paragraph (d)(2)(i) of this section is not submitted at the time a confidentiality claim is asserted, EPA will deem the claim for chemical identity waived and may make the identity public without further notice to the submitter. (3) With respect to information collected pursuant to the following provisions from subchapter R of this chapter, the provisions of Sec. 2.203 are modified as provided below. (Each provision is identified by subject matter and states the subject of the difference from Sec. 2.203.) (i) Information submitted pursuant to 40 CFR part 704, subpart A (Reporting and Recordkeeping Requirements--General Reporting and Recordkeeping Provisions for Section 8(a) Information-Gathering Rules) is subject to Sec. 704.7 of this chapter (method of asserting claims; certification requirement; effect of failure to properly assert claims). (ii) Information submitted pursuant to 40 CFR part 704, subpart C (Reporting and Recordkeeping Requirements--CAIR: Comprehensive Assessment Information Rule--General Reporting and Recordkeeping Provisions) is subject to Sec. 704.219 (method of asserting claims; substantiating claims; effect of failure to properly assert or substantiate claims). (iii) Information submitted pursuant to 40 CFR part 710, subpart A (Inventory Reporting Regulations--Compilation of the Inventory) is subject to Sec. 710.7 (method of asserting claims; substantiating claims; effect of failure to properly assert or substantiate claims). (iv) Information submitted pursuant to 40 CFR part 710, subpart B (Inventory Reporting Regulations--Partial Updating of the Inventory Data Base) is subject to Sec. 710.38 of this chapter (method of asserting claims; limitation on claims for chemical identity; substantiating claims; effect of failure to properly assert or substantiate claims). (v) Information submitted pursuant to 40 CFR part 712 (Chemical Information Rules--General Provisions) is subject to Sec. 712.15 of this chapter (certification requirement; effect of failure to properly assert or certify claims). (vi) Information submitted pursuant to 40 CFR part 716 (Health and Safety Data Reporting) is subject to Sec. 716.55 (method of asserting claims; sanitized version of document required; effect of failure to provide sanitized copy). (vii) Information submitted pursuant to 40 CFR part 717 (Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment) is subject to Sec. 717.19 of this chapter (method of asserting claims; sanitized copy of document required; effect of failure to provide sanitized copy). (viii) Information submitted pursuant to 40 CFR part 720 (Premanufacture Notification) is subject to-- (A) Section 720.80 of this chapter (method of asserting claims; effect of failure to assert claim); (B) Section 720.85(a) of this chapter (claims for confidentiality of chemical identity applicable to the period prior to commencement of manufacture or import; generic name requirement); (C) Section 720.85(b) of this chapter (claims for confidentiality of chemical identity applicable to the period after commencement of manufacture or import; method of asserting claims; substantiation requirement; effect of failure to substantiate properly; generic name requirement); (D) Section 720.87 of this chapter (method of asserting claims; generic use requirement); (E) Section 720.90 of this chapter (method of asserting claims; substantiation requirement); and (F) Section 720.102 of this chapter (reassertion and substantiation of claims for chemical identity; effect of failure to reassert or substantiate claims). (ix) Information submitted pursuant to 40 CFR 723.50 (Premanufacture Notice Exemptions--Chemical Substances Manufactured in Quantities of 1,000 Kilograms or Less per Year--Exemption Notice) is subject to Sec. 723.50 (e)(1)(E) and (k)(2) of this chapter (generic name requirement). (x) Information submitted pursuant to 40 CFR 723.250 (Premanufacture Notice Exemptions--Polymers) is subject to paragraph (d)(3)(viii)(A)-(F) of Sec. 2.306. (xi) Information submitted pursuant to 40 CFR part 761 (Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions--Notification of PCB Waste Activity) is subject to Sec. 761.205(a)(4)(viii) (certain information will not be afforded confidential treatment unless the submitter makes a sufficient showing of reasons for confidential treatment; timing of asserting claims). (xii) Information submitted pursuant to 40 CFR part 763, subpart D (Reporting Commercial and Industrial Uses of Asbestos) is subject to Sec. 763.74 (method of asserting claims: certification requirement). (xiii) Information submitted pursuant to 40 CFR part 763, subpart I (Asbestos--Prohibition on The Manufacture, Importation, Processing and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements) is subject to Sec. 763.179 (method of asserting claims; timing of asserting claims; sanitized copy of document required; effect of failure to submit a sanitized copy; substantiation requirement; effect of failure to substantiate). (xiv) Information submitted pursuant to 40 CFR part 790 (Procedures Governing Testing Consent Agreements and Test Rules) is subject to Sec. 790.7 (method of asserting claims; timing of asserting claims; substantiation requirement; effect of failure to substantiate). (e) Initial action by EPA office. Section 2.204 applies to information to which this section applies, except that the provisions of paragraph (e)(3) of this section regarding the time allowed for seeking judicial review shall be reflected in any notice furnished to a business under Sec. 2.204(d)(2). (f) Final confidentiality determination by EPA legal office. Section 2.205 applies to information to which this section applies, except that-- (1) In addition to the statement prescribed by the second sentence of Sec. 2.205(f)(2), the notice of denial of a business confidentiality claim shall state that under section 20(a) of the Act, 15 U.S.C. 2619, the business may commence an action in an appropriate Federal district court to prevent disclosure. (2) The following sentence is substituted for the third sentence of Sec. 2.205(f)(2): ``With respect to EPA's implementation of the determination the notice shall state that (subject to Sec. 2.210) EPA will make the information available to the public on the thirty-first (31st) calendar day after the date of the business' receipt of the written notice (or on such later date as is established in lieu thereof under paragraph (f)(3) of this section), unless the EPA legal office has first been notified of the business' commencement of an action in a Federal court to obtain judicial review of the determination and to obtain preliminary injunctive relief against disclosure.''; and (3) Notwithstanding Sec. 2.205(g), the 31 calendar day period prescribed by Sec. 2.205(f)(2), as modified by paragraph (e)(3) of this section, shall not be shortened without the consent of the business. (g) [Reserved] (h) Substantive criteria for use in confidentiality determinations. Section 2.208 applies without change to information to which this section applies, except that health and safety data are not eligible for confidential treatment. Notwithstanding the preceding sentence, Sec. 2.208 applies to-- (1) Health and safety data governed by Sec. 716.55(a) (3) or (4), Sec. 720.85(a)(ii), Sec. 720.90, or Sec. 723.250(g)(9) of subchapter R of this chapter; and (2) Health and safety data whose disclosure would-- (i) In the case of a chemical substance or mixture, disclose processes used in the manufacturing or processing of the chemical substance or mixture; or (ii) In the case of a mixture, disclose the portion of the mixture comprised by any of the chemical substances in the mixture. (i) Disclosure in special circumstances. Section 2.209 applies to information to which this section applies, except that-- (1) The following two additional provisions apply to Sec. 2.209(c): (i) The official purpose for which the information is needed must be in connection with the agency's duties under any law for protection of health or the environment or for specific law enforcement purposes; and (ii) EPA notifies the other agency that the information was acquired under authority of the Act and that any knowing disclosure of the information may subject the officers and employees of the other agency to the penalties in section 14(d) of the Act (15 U.S.C. 2613(d)). (2) Information governed by part 707, subpart D of this chapter (Chemical Imports and Exports--Notices of Export Under section 12(b) of the Act) may be disclosed to foreign governments pursuant to Sec. 707.75(c) of this chapter. (3) Information submitted pursuant to part 710, subpart A of this chapter (Inventory Reporting Regulations--Compilation of the Inventory) may be disclosed to a bona fide requestor pursuant to Sec. 710.7 of this chapter. (4) Information submitted pursuant to part 720 of this chapter (Premanufacture Notification) may be disclosed to a bona fide requestor pursuant to Sec. 720.85 of this chapter. (5) Information submitted pursuant to part 721 of this chapter (Significant New Uses of Chemical Substances) may be disclosed to a bona fide requestor pursuant to Secs. 721.555, 721.557, and 721.575 of this chapter. (6) Information submitted pursuant to part 723 of this chapter (Premanufacture Notice Exemptions--Polymers) may be disclosed to a bona fide requestor pursuant to Sec. 723.250(g)(7) of this chapter. (j) Disclosure of information relevant in a proceeding. (1) Under section 14(a)(4) of the Act (15 U.S.C. 2613(a)(4)), any information to which this section applies may be disclosed by EPA when the information is relevant in a proceeding under the Act, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. However, any such disclosure shall be made in a manner that preserves the confidentiality of the information to the extent practicable without impairing the proceeding. Disclosure of information to which this section applies because of its relevance in a proceeding shall be made only in accordance with this paragraph (j). (2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be followed when making disclosures pursuant to this paragraph (j). (k) Disclosure of information to contractors and subcontractors. (1) Under section 14(a)(2) of the Act (15 U.S.C. 2613(a)(2)), any information to which this section applies may be disclosed by EPA to a contractor or subcontractor of the United States performing work under the Act, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Subject to the limitations in this paragraph (j), information to which this section applies may be disclosed (i) To a contractor or subcontractor with EPA, if the EPA program office managing the contract first determines in writing that such disclosure is necessary for the satisfactory performance by the contractor or subcontractor of the contract or subcontract; or (ii) To a contractor or subcontractor with an agency other than EPA, if the EPA program office which provides the information to that agency, contractor, or subcontractor first determines in writing, in consultation with the General Counsel, that such disclosure is necessary for the satisfactory performance by the contractor or subcontractor of the contract or subcontract. (2) The provisions of Sec. 2.301(h)(2) (ii) and (iii) must be followed when making disclosures pursuant to this paragraph (k). (3) At the time any information is furnished to a contractor or subcontractor under this paragraph (k), the EPA office furnishing the information to the contractor or subcontractor shall notify the contractor or subcontractor that the information was acquired under authority of the Act and that any knowing disclosure of the information may subject the contractor or subcontractor and its employees to the penalties in section 14(d) of the Act (15 U.S.C. 2613(d)). (l) Disclosure of information when necessary to protect health or the environment against an unreasonable risk of injury. (1) Under section 14(a)(3) of the Act (15 U.S.C. 2613(a)(3)), any information to which this section applies may be disclosed by EPA when disclosure is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment. However, any disclosure shall be made in a manner that preserves the confidentiality of the information to the extent not inconsistent with protecting health or the environment against the unreasonable risk of injury. Disclosure of information to which this section applies because of the need to protect health or the environment against an unreasonable risk of injury shall be made only in accordance with paragraph (k) of this section. (2) If any EPA office determines that there is an unreasonable risk of injury to health or the environment and that to protect health or the environment against the unreasonable risk of injury it is necessary to disclose information to which this section applies that otherwise might be entitled to confidential treatment under this subpart, the EPA office shall notify the General Counsel in writing of the nature of the unreasonable risk of injury, the extent of the disclosure proposed, how the proposed disclosure will serve to protect health or the environment against the unreasonable risk of injury, and the proposed date of disclosure. Such notification shall be made as soon as practicable after discovery of the unreasonable risk of injury. If the EPA office determines that the risk of injury is so imminent that it is impracticable to furnish written notification to the General Counsel, the EPA office shall notify the General Counsel orally. (3) Upon receipt of notification under paragraph (k)(2) of this section, the General Counsel shall make a determination in writing whether disclosure of information to which this section applies that otherwise might be entitled to confidential treatment is necessary to protect health or the environment against an unreasonable risk of injury. The General Counsel shall also determine the extent of disclosure necessary to protect against the unreasonable risk of injury as well as when the disclosure must be made to protect against the unreasonable risk of injury. (4) If the General Counsel determines that disclosure of information to which this section applies that otherwise might be entitled to confidential treatment is necessary to protect health or the environment against an unreasonable risk of injury, the General Counsel shall furnish notice to each affected business of the contemplated disclosure and of the General Counsel's determination. Such notice shall be made in writing by certified mail, return receipt requested, at least 15 days before the disclosure is to be made. The notice shall state the date upon which disclosure will be made. However, if the General Counsel determines that the risk of injury is so imminent that it is impracticable to furnish such notice 15 days before the proposed date of disclosure, the General Counsel may provide notice by means that will provide receipt of the notice by the affected business at least 24 hours before the disclosure is to be made. This may be done by telegram, telephone, or other reasonably rapid means. (m) Sunset provisions. (1) Pursuant to Secs. 2.216, 720.85, 720.90, and 720.102, claims for confidentiality of chemical identity in Premanufacture Notifications expire upon commencement of manufacture or export unless reasserted in the Notice of Commencement. (2) Pursuant to Secs. 2.216 and 723.250(g) (7), (9), and (11), claims for confidentiality of chemical identity in Polymer Exemption Applications expire upon commencement of manufacture or export unless reasserted in the Notice of Commencement. (3) Notwithstanding Sec. 2.216(a), the provisions of this paragraph (m) apply to claims for confidentiality of chemical identity in Premanufacture Notifications and Polymer Exemption Applications, regardless of whether they were submitted on or after [insert effective date of final rule]. Sec. 2.307 Special rules governing certain information obtained under the Federal Insecticide, Fungicide and Rodenticide Act. (a) Definitions. For the purposes of this section: (1) Act means the Federal Insecticide, Fungicide and Rodenticide Act, as amended, 7 U.S.C. 136 et seq., and its predecessor, 7 U.S.C. 135 et seq. (2) Applicant means any person who has submitted to EPA (or to a predecessor agency with responsibility for administering the Act) a registration statement or application for registration under the Act of a pesticide or of an establishment. (3) Registrant means any person who has obtained registration under the Act either of a pesticide or of an establishment. (4) Qualified person means 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. (5) Safety and efficacy data means all information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism. Data concerning a pesticide which has never been registered do not constitute safety and efficacy data. (b) Applicability. This section applies to all information submitted to EPA by an applicant or registrant for the purpose of satisfying some requirement or condition of the Act or of regulations which implement the Act, including information originally submitted to EPA for some other purpose but incorporated by the applicant or registrant into a submission in order to satisfy some requirement or condition of the Act or of regulations which implement the Act. This section does not apply to information supplied to EPA by a petitioner in support of a petition for a tolerance under 21 U.S.C. 346a(d), unless the information is also described by the first sentence of this paragraph. (c) Basic rules which apply without change. Sections 2.201 through 2.203, 2.206, 2.207, 2.210 through 2.212, and 2.214 through 2.216 apply without change to information to which this section applies. (d) Method of asserting business confidentiality claim. Section 2.203 applies to information to which this section applies, except that-- (1) Information submitted pursuant to part 154, Special Review Procedures, shall be subject to the requirements of Sec. 154.15(c) of this chapter. (2) Information submitted pursuant to part 155, Registration Standards, shall be subject to the requirements of Sec. 155.30(c) of this chapter. (3) Information submitted pursuant to part 158, Data Requirements for Registration, shall be subject to the requirements of Sec. 158.33 of this chapter. (4) Analytical methods submitted pursuant to Sec. 158.240 of this chapter and used to enforce residue limits for emergency exemptions, temporary tolerances and permanent tolerances must be available for use by enforcement agencies and thus may not be claimed as confidential business information. (e) Initial action by EPA office. Section 2.204 applies to information to which this section applies, except that the provisions of paragraph (e) of this section regarding the time allowed for seeking judicial review shall be reflected in any notice furnished to a business under Sec. 2.204(d)(2). (f) Final confidentiality determination by EPA legal office. Section 2.205 applies to information to which this section applies, except that-- (1) In addition to the statement prescribed by the second sentence of Sec. 2.205(f)(2), the notice of denial of a business confidentiality claim shall state that under section 10(c) of the Act, 7 U.S.C. 136h(c), the business may commence an action in an appropriate Federal district court for a declaratory judgment; (2) The following sentence is substituted for the third sentence of Sec. 2.205(f)(2): ``With respect to EPA's implementation of the determination, the notice shall state that (subject to Sec. 2.210) EPA will make the information available to the public on the thirty-first (31st) calendar day after the date of the business' receipt of the written notice (or on such later date as is established in lieu thereof under paragraph (f)(3) of this section), unless the EPA legal office has first been notified of the business' commencement of an action in a Federal court to obtain judicial review of the determination or to obtain a declaratory judgment under section 10(c) of the Act and to obtain preliminary injunctive relief against disclosure.''; and (3) Notwithstanding Sec. 2.205(g), the 31 calendar day period prescribed by Sec. 2.205(f)(2), as modified by paragraph (e)(3) of this section, shall not be shortened without the consent of the business. (g) Substantive criteria for use in confidentiality determinations. Section 2.208 applies without change to information to which this section applies except as provided in this paragraph (g). No information to which this section applies is voluntarily submitted information. (1) Safety and efficacy data are not eligible for confidential treatment. Notwithstanding the preceding sentence, Sec. 2.208 applies where an affected business has shown that disclosure of the information would disclose one or more of the following types of information: (i) Manufacturing or quality control processes; (ii) Details of any methods for testing, detection, or measuring the quantity of any deliberately added inert ingredient of a pesticide; or (iii) The identity or percentage quantity of any deliberately added inert ingredient of a pesticide. (2) The following information on the purchaser acknowledgement statement submitted pursuant to section 17(a)(2) of the Act is not eligible for confidential treatment, unless the purchaser acknowledgement statement pertains to a research and development product (in which case Sec. 2.208 applies): (i) The identity of the importing country; (ii) The identity of the producer of the unregistered pesticide; (iii) The identity of the exporting company; (iv) The name of the unregistered pesticide product; and (v) The name of the active ingredient. (h) Disclosure in special circumstances. (1) Section 2.209 applies without change to information to which this section applies. In addition, under section 12(a)(2)(D) of the Act, 7 U.S.C. 136j(a)(2)(D), EPA possesses authority to disclose any information to which this section applies to physicians, pharmacists, and other qualified persons needing such information for the performance of their duties, notwithstanding the fact that the information might otherwise be entitled to confidential treatment under this subpart. Such authority under section 12(a)(2)(D) of the Act may be exercised in accordance with paragraph (h)(2) or (h)(3) of this section. (2) Information to which this section applies may be disclosed (notwithstanding the fact that it might otherwise be entitled to confidential treatment under this subpart) to physicians, pharmacists, hospitals, veterinarians, law enforcement personnel, or Federal, State, or local governmental agencies with responsibilities for protection of public health, and to employees of any such persons or agencies, or to other qualified persons, when and to the extent that disclosure is necessary in order to treat illness or injury or to prevent imminent harm to persons, property, or the environment, in the opinion of the Administrator or his designee. (3)(i) Information to which this section applies may be disclosed (notwithstanding the fact that it otherwise might be entitled to confidential treatment under this subpart)-- (A) To a contractor or subcontractor with EPA, if the EPA program office managing the contract first determines in writing that such disclosure is necessary for the satisfactory performance of a contract or subcontract in connection with the Act; or (B) To a contractor or subcontractor with a Federal agency other than EPA, if the EPA program office which provides the information to that agency, contractor, or subcontractor first determines in writing, in consultation with the General Counsel, that such disclosure is necessary for the satisfactory performance of a contract or subcontract in connection with the Act. (ii) The provisions of Sec. 2.301(h)(2) (ii) and (iii) must be followed when making disclosures pursuant to this paragraph (h)(3). (iii) At the time any information is furnished to a contractor or subcontractor under this paragraph (h)(3), the EPA office furnishing the information to the contractor or subcontractor shall notify the contractor or subcontractor that the information was acquired under authority of the Act and that any knowing disclosure of the information may subject the contractor or subcontractor and its employees to the penalties in section 10(f) of the Act (7 U.S.C. 136h(f)). (iv) Contractors receiving information to which this section applies will be required to follow the security procedures established in the ``FIFRA Information Security Manual,'' which is available through the Office of Pesticide Programs, Information Services Branch. (v) For purposes of this section, the term ``contract'' includes grants and cooperative agreements under the Environmental Programs Assistance Act of 1984 (Pub. L. 98-313), and the term ``contractor'' includes grantees and cooperators under the Environmental Programs Assistance Act of 1984. (4) Information to which this section applies, and which relates to formulas of products, may be disclosed at any public hearing under the Act. Prior to such disclosure, EPA will follow the procedures set forth in Sec. 2.301(g)(3) and (4), which are incorporated here by reference. (5) Information to which this section applies, and which relates to formulas of products, may be disclosed in findings of fact issued by the Administrator under the Act. No information shall be made available to the public under this paragraph (h)(5) until (i) The official responsible for issuing the findings of fact has made a written finding that disclosure is necessary to carry out the provisions of the Act; (ii) EPA has notified the affected business by certified mail, return receipt requested, of the Agency's intent to disclose the information; and (iii) Thirty calendar days have passed since the business' receipt of the notice required under paragraph (h)(5)(ii) of this section. (6) Information to which this section applies, and which concerns production, sale, or inventories of a pesticide that is otherwise entitled to confidential treatment may be disclosed in connection with a public proceeding to determine whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment. In proposing to disclose such information, EPA will follow the procedures set forth in Sec. 2.301(g)(2)-(4), except that before disclosing the information, EPA will make a determination that the disclosure is necessary in the public interest, and will give all affected businesses thirty days advance notice by certified mail, return receipt requested. During the thirty day period, the submitter will have the opportunity to seek judicial review. (7)(i) Under section 10(d)(1) of the Act (7 U.S.C 136(d)(1)), any safety and efficacy data (as defined in paragraph (a)(5) of this section) to which this section applies and which falls within one of the classes of information defined by paragraph (g) (1), (2), or (3) of this section may be disclosed by EPA when disclosure is necessary to protect against an unreasonable risk of injury to health or the environment. However, any disclosure shall be made in a manner that preserves the confidentiality of the information to the extent not inconsistent with protecting health or the environment against the unreasonable risk of injury. Disclosure of information to which this section applies because of the need to protect health or the environment against an unreasonable risk of injury shall be made only in accordance with this paragraph (h)(7). (ii) The provisions of Sec. 2.306(l) (2) and (3) must be followed when making disclosures pursuant to this paragraph (h)(7). (iii) If the General Counsel determines that disclosure of information to which this section applies that otherwise might be entitled to confidential treatment is necessary to protect health or the environment against an unreasonable risk of injury, the General Counsel shall furnish notice to each affected business of the contemplated disclosure and of the General Counsel's determination. Such notice shall be made in writing by certified mail, return receipt requested, at least 30 days before the disclosure is to be made. The notice shall state the date upon which disclosure will be made. However, if the General Counsel determines that the risk of injury is so imminent that it is impracticable to furnish such notice 30 days before the proposed date of disclosure, the General Counsel may provide notice by means that will provide receipt of the notice by the affected business at least 10 days before the disclosure is to be made. This may be done by telegram, telephone, or other reasonably rapid means. (8) Information required to be produced pursuant to part 164 (rules of practice governing regulatory hearings under the Act) and which any party to the proceeding claims is a trade secret or commercial or financial information (other than information relating to the formulas of a pesticide) shall be subject to the requirements of Sec. 164.4(c). (i) Restriction on disclosure to foreign or multinational entities (1) A request (including any request submitted pursuant to subpart A of this part) for data obtained from an applicant or registrant under the Act must be made in writing, and must be accompanied by a signed affirmation as required by section 10(g)(1) of the Act. The affirmation must contain the language specified in paragraph (i)(2) of this section. If EPA receives a request that is not accompanied by a signed affirmation, EPA will return the request unprocessed (if the request also includes information not within the scope of this paragraph (i), the remainder of the request will be handled pursuant to the procedures in subpart A of this part). This paragraph (i) does not apply to reviews of data 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. (2) The requestor must sign the following affirmation: I have requested access to data submitted by an applicant or registrant under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) to the Environmental Protection Agency. I hereby affirm: That I do not seek access to the data for the purpose of delivering it or offering it for sale to 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 its agents or employees; and That I will not purposefully deliver or negligently cause the data to be delivered to any such business or entity or its agents or employees. I am aware that I may be subject to criminal penalties under 18 U.S.C 1001 if I have made any statement of material facts knowing that such statement is false or if I willfully conceal any material fact. (Signature, Name, Address, Organization or Affiliation, Client.) (3) The first time EPA discloses data submitted by a specific applicant or registrant under the Act in response to a written request by a member of the public, EPA will provide written notice to the applicant or registrant. The notice will include a copy of the affirmation and a listing of the data disclosed, and will advise the applicant or registrant that EPA maintains a file of affirmations and data disclosure listings. Copies of future affirmations and data disclosure listings may be obtained by the appropriate registrants and applicants by request to EPA. (4) Notwithstanding any other provision of this paragraph (i), data submitted by an applicant or registrant under the Act which is not subject to a claim of confidentiality may be disclosed to any person in connection with a public proceeding where the information is relevant to a determination by the Administrator as to whether a pesticide, or an ingredient of a pesticide, causes unreasonable adverse effects on health or the environment. EPA will disclose the information only after a finding by the appropriate official that the information is relevant to such a determination. No advance notice will be given of such disclosures. (j) Designation by business of addressee for notices and inquiries. Section 2.213 applies to information to which this section applies, except that designations by registrants and applicants submitting information pursuant to part 152 of this chapter shall be made pursuant to Sec. 152.50(b) (2) and (3) of this chapter. (k) Availability of material in support of registration and reviews of pesticide data. Regardless of any claims of confidentiality-- (1) Within 30 days after registration under the Act, EPA will make available for public inspection, by request, and without notice to affected businesses, the materials required by subpart E of part 152 of this chapter to be submitted with an application for registration. Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable; and (2) EPA may make available to the public, without notice to affected businesses, reviews of safety and efficacy data which do not contain (or from which has been deleted) any information, the disclosure of which would in turn disclose-- (i) Information described in paragraphs (g)(1) (i)-(iii) of this section; or (ii) Unpublished information concerning the production, distribution, sale, or inventories of a pesticide. Sec. 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act. (a) Definitions. For the purposes of this section: (1) Act means the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting the pesticide chemical from the necessity of a tolerance, pursuant to section 408(d) of the Act, 21 U.S.C. 346a(d). (3) Petitioner means a person who has submitted a petition to EPA (or to a predecessor agency). (b) Applicability. (1) This section applies only to business information submitted to EPA (or to an advisory committee established under the Act) by a petitioner, solely in support of a petition which has not been acted on by the publication by EPA of a regulation establishing a tolerance for a pesticide chemical or exempting the pesticide chemical from the necessity of a tolerance, as provided in section 408(d) (2) or (3) of the Act, 21 U.S.C. 346a(d) (2) or (3). (2) Section 2.307, rather than this section, applies to information described by the first sentence of Sec. 2.307(b) (material incorporated into submissions in order to satisfy the requirements of the Federal Insecticide, Fungicide and Rodenticide Act, as amended), even though such information was originally submitted by a petitioner in support of a petition. (3) This section does not apply to information gathered by EPA under a proceeding initiated by EPA to establish a tolerance under section 408(e) of the Act, 21 U.S.C. 346a(e). (c) Basic rules which apply without change. Sections 2.201, 2.202, 2.206, 2.207, and 2.210 through 2.216 apply without change to information to which this section applies. (d) Effect of submission of information without claim. Section 2.203 (a), (b), and (c)(1) apply without change to information to which this section applies, except that summaries of petitions required under Sec. 177.102(j) of this chapter may not be claimed as confidential. Section 2.203(c)(2) does not apply to information to which this section applies. A petitioner's failure to assert a claim when initially submitting a petition shall not constitute a waiver of any claim the petitioner may have. (e) Initial action by EPA office. Section 2.204 applies to information to which this section applies, except that-- (1) Unless the EPA office has on file a written waiver of petitioner's claim, a petitioner shall be regarded as an affected business, a petition shall be treated as if it were covered by a business confidentiality claim, and an EPA office acting under Sec. 2.204(d) shall determine that the information in the petition is or may be entitled to confidential treatment and shall take action in accordance with Sec. 2.204(d)(1); (2) In addition to other required provisions of any notice furnished to a petitioner under Sec. 2.204(e), such notice shall state that-- (i) Section 408(f) of the Act, 21 U.S.C. 346a(f), affords absolute confidentiality to information to which this section applies, but after publication by EPA of a regulation establishing a tolerance (or exempting the pesticide chemical from the necessity of a tolerance) neither the Act nor this section affords any protection to the information; (ii) Information submitted in support of a petition which is also incorporated into a submission in order to satisfy a requirement or condition of the Federal Insecticide, Fungicide and Rodenticide Act, as amended, 7 U.S.C. 136 et seq., is regarded by EPA as being governed, with respect to business confidentiality, by Sec. 2.307 rather than by this section; (iii) Although it appears that this section may apply to the information at this time, EPA is presently engaged in determining whether for any reason the information is entitled to confidential treatment or will be entitled to such treatment if and when this section no longer applies to the information; and (iv) Information determined by EPA to be covered by this section will not be disclosed for as long as this section continues to apply, but will be made available to the public thereafter (subject to Sec. 2.210) unless the business furnishes timely comments in response to the notice. (f) Final confidentiality determination by EPA legal office. Section 2.205 applies to information to which this section applies, except that-- (1) In addition to the circumstances mentioned in Sec. 2.205(f)(1), notice in the form prescribed by Sec. 2.205(f)(2) shall be furnished to each affected business whenever information is found to be entitled to confidential treatment under section 408(f) of the Act but not otherwise entitled to confidential treatment. With respect to such cases, the following sentences shall be substituted for the third sentence of Sec. 2.205(f)(2): ``With respect to EPA's implementation of the determination, the notice shall state that (subject to Sec. 2.210) EPA will make the information available to the public on the thirty- first (31st) calendar day after the business' receipt of the written notice (or on such later date as is established in lieu thereof under paragraph (f)(3) of this section), unless the EPA legal office has first been notified of the business' commencement of an action in a Federal court to obtain judicial review of the determination and to obtain preliminary injunctive relief against disclosure; provided, that the information will not be made available to the public for so long as it is entitled to confidential treatment under section 408(f) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(f).''; and (2) Notwithstanding Sec. 2.205(g), the 31 calendar day period prescribed by Sec. 2.205(f)(2), as modified by paragraph (f)(2) of this section, shall not be shortened without the consent of the business. (g) [Reserved] (h) Substantive criteria for use in confidentiality determinations. Section 2.208 does not apply to information to which this section applies. Such information shall be determined to be entitled to confidential treatment for so long as this section continues to apply to it. (i) Disclosure in special circumstances. (1) Section 2.209 applies to information to which this section applies. In addition, under Section 408(f) of the Act, 21 U.S.C. 346a(f), EPA is authorized to disclose the information to other persons. Such authority under section 408(f) of the Act may be exercised only in accordance with paragraph (i)(2) or (i)(3) of this section. (2) Information to which this section applies may be disclosed (notwithstanding the fact that it otherwise might be entitled to confidential treatment under this subpart) to a person under contract to EPA to perform work for EPA in connection with the Act, with the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, or regulations which implement either such Act, if the EPA program office managing the contract first determines in writing that such disclosure is necessary in order that the contractor may carry out the work required by the contract. Any such disclosure to a contractor shall be made only in accordance with the procedures and requirements of Sec. 2.301(h)(2)(ii) and (h)(2)(iii). (3) Information to which this section applies may be disclosed by EPA to an advisory committee in accordance with section 408(d) of the Act, 21 U.S.C. 346a(d). Sec. 2.309 Special rules governing certain information obtained under the Marine Protection, Research and Sanctuaries Act of 1972. (a) Definitions. For the purposes of this section: (1) Act means the Marine Protection, Research and Sanctuaries Act of 1972, 33 U.S.C. 1401 et seq. (2) Permit means any permit applied for or granted under the Act. (3) Application means an application for a permit. (b) Applicability. This section applies to all information provided to or obtained by EPA as a part of any application or in connection with any permit. (c) Basic rules which apply without change. Sections 2.201 through 2.207 and 2.209 through 2.216 apply without change to information to which this section applies. (d) Substantive criteria for use in confidentiality determinations. Section 2.208 does not apply to information to which this section applies. Pursuant to section 104(f) of the Act, 33 U.S.C. 1414(f), no information to which this section applies is eligible for confidential treatment. Sec. 2.310 Special rules governing certain information obtained under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended. (a) Definitions. For purposes of this section: (1) Act means the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, including amendments made by the Superfund Amendments and Reauthorization Act of 1986, 42 U.S.C. 9601, et seq. (2) Person has the meaning given it in section 101(21) of the Act, 42 U.S.C. 9601(21). (3) Facility has the meaning given it in section 101(9) of the Act, 42 U.S.C. 9601(9). (4) Hazardous substance has the meaning given it in section 101(14) of the Act, 42 U.S.C. 9601(14). (5) Release has the meaning given it in section 101(22) of the Act, 42 U.S.C. 9601(22). (6) Proceeding means any rulemaking or adjudication conducted by EPA under the Act or under regulations which implement the Act (including the issuance of administrative orders under section 106 of the Act and cost recovery pre-litigation settlement negotiations under sections 107 or 122 of the Act), any cost recovery litigation under section 107 of the Act, or any administrative determination made under section 104 of the Act, but not including determinations under this subpart. (b) Applicability. This section applies only to information provided to or obtained by EPA under section 104 of the Act, 42 U.S.C. 9604, by or from any person who stores, treats, or disposes of hazardous wastes; or where necessary to ascertain facts not available at the facility where such hazardous substances are located, by or from any person who generates, transports, or otherwise handles or has handled hazardous substances, or by or from any person who performs or supports removal or remedial actions pursuant to section 104(a) of the Act. Information will be considered to have been provided or obtained under section 104 of the Act if it was provided in response to a request from EPA or a representative of EPA made for any of the purposes stated in section 104, if it was provided pursuant to the terms of a contract, grant or other agreement to perform work pursuant to section 104, or if its submission could have been required under section 104, regardless of whether section 104 was cited as authority for any request for the information or whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) [Reserved] (f) [Reserved] (g) Disclosure of information relevant to a proceeding. (1) Under section 104(e)(7)(A) of the Act (42 U.S.C. 9604(e)(7)(A)) any information to which this section applies may be disclosed by EPA because of the relevance of the information in a proceeding under the Act, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Disclosure of information to which this section applies because of its relevance in a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g)(2) must be followed when making disclosures pursuant to paragraph (g) of this section. (3) In connection with any proceeding involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, except with respect to litigation conducted by a Federal court, information to which this section applies which may be entitled to confidential treatment may be made available to the public, or to one or more parties of record to the proceeding, upon EPA's initiative, under this paragraph (g)(3). An EPA office proposing disclosure of information under this paragraph (g)(3), shall so notify the presiding officer in writing. Upon receipt of such a notification, the presiding officer shall notify each affected business that disclosure under this paragraph (g)(3) has been proposed, and shall afford each such business a period for comment found by the presiding officer to be reasonable under the circumstances. Information may be disclosed under this paragraph (g)(3) only if, after consideration of any timely comments submitted by the business, the EPA office determines in writing that, for reasons directly associated with the conduct of the proceeding, the contemplated disclosure would serve the public interest, and the presiding officer determines in writing that the information is relevant to a matter in controversy in the proceeding. The presiding officer may condition disclosure of the information to a party of record on the making of such protective arrangements and commitments as he finds to be warranted. Disclosure to one or more parties of record, under protective arrangements or commitments, shall not, of itself, affect the eligibility of information for confidential treatment under the other provisions of this subpart. Any affected business shall be given at least 5 days notice by the presiding officer prior to making the information available to the public or to one or more of the parties of record to the proceeding. (4) In connection with any proceeding involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, except with respect to litigation conducted by a Federal court, information to which this section applies which may be entitled to confidential treatment may be made available to one or more parties of record to the proceeding, upon request of a party, under this paragraph (g)(4). A party of record seeking disclosure of information shall direct his request to the presiding officer. Upon receipt of such a request, the presiding officer shall notify each affected business that disclosure under this paragraph (g)(4) has been requested, and shall afford each such business a period for comment found by the presiding officer to be reasonable under the circumstances. Information may be disclosed to a party of record under this paragraph (g)(4) only if, after consideration of any timely comments submitted by the business, the presiding officer determines in writing both that the party of record has satisfactorily shown that with respect to a significant matter which is in controversy in the proceeding, the party's ability to participate effectively in the proceeding will be significantly impaired unless the information is disclosed to him, and that any harm to an affected business that would result from the disclosure is likely to be outweighed by the benefit to the proceeding and the public interest that would result from the disclosure. The presiding officer may condition disclosure of the information to a party of record on the making of such protective arrangements and commitments as he finds to be warranted. Disclosure to one or more parties of record, under protective arrangements or commitments, shall not, of itself, affect the eligibility of information for confidential treatment under the other provisions of this subpart. Any affected business shall be given at least 5 days notice by the presiding officer prior to making the information available to one or more of the parties of record to the proceeding. (5) In connection with cost recovery pre-litigation settlement negotiations under section 107 or 122 of the Act (42 U.S.C. 9607, 9622), any information to which this section applies that may be entitled to confidential treatment may be made available to potentially responsible parties pursuant to a contractual agreement to protect the information. (6) In connection with any cost recovery proceeding under section 107 of the Act involving a decision by a presiding officer after an evidentiary or adjudicatory hearing, any information to which this section applies that may be entitled to confidential treatment may be made available to one or more parties of record to the proceeding, upon EPA's initiative, under this paragraph (g)(6). Such disclosure must be made pursuant to a stipulation and protective order signed by all parties to whom disclosure is made and by the presiding officer. (h) Disclosure to authorized representatives. (1) Under section 104(e)(7) of the Act (42 U.S.C. 9604(e)(7)), EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information might otherwise be entitled to confidential treatment under this subpart. (2) The provisions of Sec. 2.301(h)(2) and (h)(3) must be followed when making disclosures pursuant to paragraph (h) of this section. (3) At the time any information is furnished to a contractor, subcontractor, or State or local government agency under this paragraph (h), the EPA office furnishing the information to the contractor, subcontractor, or State or local government agency shall notify the contractor, subcontractor, or State or local government agency that the information may be entitled to confidential treatment and that any knowing and willful disclosure of the information may subject the contractor, subcontractor, or State or local government agency and its employees to penalties in section 104(e)(7)(B) of the Act (42 U.S.C. 9604(e)(7)(B)). Sec. 2.311 Special rules governing certain information obtained under the Motor Vehicle Information and Cost Savings Act. (a) Definitions. For the purposes of this section: (1) Act means the Motor Vehicle Information and Cost Savings Act, as amended, 15 U.S.C. 1901 et seq. (2) Average fuel economy has the meaning given it in section 501(4) of the Act, 15 U.S.C. 2001(4). (3) Fuel economy has the meaning given it in section 501(6) of the Act, 15 U.S.C. 2001(6). (4) Fuel economy data means any measurement or calculation of fuel economy for any model type and average fuel economy of a manufacturer under section 503(d) of the Act, 15 U.S.C. 2003(d). (5) Manufacturer has the meaning given it in section 501(9) of the Act, 15 U.S.C. 2001(9). (6) Model type has the meaning given it in section 501(11) of the Act, 15 U.S.C. 2001(11). (b) Applicability. This section applies only to information provided to or obtained by EPA under Title V, Part A of the Act, 15 U.S.C. 2001 through 2012. Information will be considered to have been provided or obtained under Title V, Part A of the Act if it was provided in response to a request from EPA made for any purpose stated in Title V, Part A, or if its submission could have been required under Title V, Part A, regardless of whether Title V, Part A was cited as the authority for any request for information or whether the information was provided directly to EPA or through some third person. (c) Basic rules which apply without change. Sections 2.201 through 2.207 and Secs. 2.209 through 2.216 apply without change to information to which this section applies. (d) [Reserved] (e) Substantive criteria for use in confidentiality determinations. Section 2.208 applies without change to information to which this section applies, except that information that is fuel economy data is not eligible for confidential treatment. (f) [Reserved] (g) Disclosure of information relevant to a proceeding. (1) Under section 505(d)(1) of the Act, any information to which this section applies may be released by EPA because of the relevance of the information to a proceeding under Title V, Part A of the Act, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information to which this section applies because of its relevance to a proceeding shall be made only in accordance with this paragraph (g). (2) The provisions of Sec. 2.301(g)(2), (g)(3), and (g)(4) must be followed when making disclosures pursuant to paragraph (g) of this section. PART 57--[AMENDED] 5. The authority citation for part 57 continues to read as follows: Authority: Secs. 110, 114, 119, 301, Clean Air Act as amended (42 U.S.C. 7410, 7414, 7419, and 7601); sec. 406 of Pub. L. 95-95. 6. Section 57.203 is amended by revising the first sentence of paragraph (a) to read as follows: Sec. 57.203 Contents of the application. (a) Claim of confidentiality. The smelter owner may make a business confidentiality claim covering all or part of the information in the NSO application in accordance with 40 CFR part 2, subpart B. * * * * * * * * 7. Appendix A of part 57 is amended by revising the second sentence of instruction 1.3 to read as follows: Appendix A to Part 57--Primary Nonferrous Smelter Order (NSO) Application * * * * * 1.3 Confidentiality. * * * Agency regulations concerning claims of confidentiality of business information are contained in 40 CFR part 2, subpart B. * * * * * * * * PART 85--[AMENDED] 8. The authority citation for part 85 continues to read as follows: Authority: Secs. 202, 208, and 301(a), Clean Air Act, as amended (42 U.S.C. 7521, 7542 and 7601(a)). 9. Section 85.1712 is amended by revising paragraph (e) to read as follows: Sec. 85.1712 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. 10. Section 85.1808 is amended by revising paragraph (e) to read as follows: Sec. 85.1808 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. 11. Section 85.1909 is amended by revising paragraph (e) to read as follows: Sec. 85.1909 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. 12. Section 85.2123 is amended by revising paragraph (e) to read as follows: Sec. 85.2123 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. PART 86--[AMENDED] 13. The authority citation for part 86 continues to read as follows: Authority: Secs. 202, 203, 206, 207, 208, 215, 301(a), Clean Air Act, as amended (42 U.S.C. 7521, 7522, 7524, 7525, 7541, 7549, 7550, 7552, and 7601(a)), unless otherwise noted. 14. Section 86.615-84 is amended by revising paragraph (e) to read as follows: Sec. 86.615-84 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. 15. Section 86.1015 is amended by revising paragraph (e) to read as follows: Sec. 86.1015 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. 16. Section 86.1116-87 is amended by revising paragraph (e) to read as follows: Sec. 86.1116-87 Treatment of confidential information. * * * * * (e) Information provided without a claim of confidentiality at the time of submission may be made available to the public by EPA without further notice to the submitter. PART 122--[AMENDED] 17. The authority citation for part 122 continues to read as follows: Authority: The Clean Water Act, 33 U.S.C. 1251 et seq. 18. Section 122.7 is amended by revising paragraph (a) to read as follows: Sec. 122.7 Confidentiality of information. (a) In accordance with 40 CFR part 2, any information submitted to EPA pursuant to these regulations may be claimed as confidential by the submitter. Any such claim must be asserted at the time of submission in the manner prescribed in the application form or instructions or, in the case of other submission, by stamping the words ``confidential business information'' on each page containing such information. If no claim is made at the time of submission, EPA may make the information available to the public without further notice. 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. 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. If a claim is asserted, the information will be treated in accordance with the procedures in 40 CFR part 2 (Public Information). * * * * * PART 123--[AMENDED] 19. The authority citation for part 123 continues to read as follows: Authority: Clean Water Act, 33 U.S.C. 1251 et seq. 20. Section 123.41 is amended by revising paragraph (a) to read as follows: Sec. 123.41 Sharing of information. (a) Any information obtained or used in the administration of a State program shall be available to EPA upon request without restriction. If the information has been submitted to the State under a claim of confidentiality, the State must submit that claim to EPA when providing information under this section. Any information obtained from a State and subject to a claim of confidentiality will be treated in accordance with the regulations in 40 CFR part 2. If EPA obtains from a State information that is not claimed to be confidential, EPA may make that information available to the public without further notice. 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. 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. * * * * * 21. Section 123.42 is amended by revising the first sentence of the introductory text to read as follows: Sec. 123.42 Receipt and use of Federal information. Upon approving a State permit program, EPA shall send to the State agency administering the permit program, subject to the conditions in 40 CFR part 2, any relevant information which was collected by EPA. * * * * * * * * PART 145--[AMENDED] 22. The authority citation for part 145 continues to read as follows: Authority: 42 U.S.C. 300f et seq. 23. Section 145.14 is amended by revising paragraph (a) to read as follows: Sec. 145.14 Sharing of information. (a) Any information obtained or used in the administration of a State program shall be available to EPA upon request without restriction. If the information has been submitted to the State under a claim of confidentiality, the State must submit that claim to EPA when providing information under this section. Any information obtained from a State and subject to a claim of confidentiality will be treated in accordance with the regulations in 40 CFR part 2. If EPA obtains from a State information that is not claimed to be confidential, EPA may make that information available to the public without further notice. 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. 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. * * * * * PART 233--[AMENDED] 24. The authority citation for part 233 continues to read as follows: Authority: Clean Water Act, 33 U.S.C. 1251 et seq. 25. Section 233.3 is amended by revising paragraph (a) to read as follows: Sec. 233.3 Confidentiality of information. (a) Any information submitted to EPA pursuant to these regulations may be claimed as confidential by the submitter at the time of submittal. Information so claimed will be treated in accordance with the procedures in 40 CFR part 2. * * * * * PART 260--[AMENDED] 26. The authority citation for part 260 continues to read as follows: Authority: 42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934, 6935, 6937, 6938, 6939, and 6974. 27. Section 260.2 is amended by revising paragraph (b) to read as follows: Sec. 260.2 Availability of information; confidentiality of information. * * * * * (b) Any person who submits information to EPA in accordance with parts 260 through 266 and 268 of this chapter may assert a claim of business confidentiality covering part or all of that information by following the procedures set forth in Sec. 2.203(b) of this chapter. Information covered by such a claim will be disclosed by EPA only to the extent, and by means of the procedures, set forth in part 2, subpart B, of this chapter. However, 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 person submitting it. 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. 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. Pursuant to Sec. 2.305(f) of this chapter, information required by Sec. 262.53(a) which is submitted in notification 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. PART 270--[AMENDED] 28. The authority citation for part 270 continues to read as follows: Authority: 42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and 6974. 29. Section 270.12 is amended by revising paragraph (a) to read as follows: Sec. 270.12 Confidentiality of information. (a) In accordance with 40 CFR part 2, any information submitted to EPA pursuant to these regulations may be claimed as confidential by the submitter. Any such claim must be asserted at the time of submission in the manner prescribed in the application form or instructions or, in the case of other submissions, by stamping the words ``confidential business information'' on each page containing such information. If no claim is made at the time of submission, EPA may make the information available to the public without further notice. 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. 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. If a claim is asserted, the information will be treated in accordance with the procedures in 40 CFR part 2 (Public Information). * * * * * PART 271--[AMENDED] 30. The authority citation for part 271 continues to read as follows: Authority: 42 U.S.C. 9602; 33 U.S.C. 1321 and 1361. 31. Section 271.17 is amended by revising paragraph (a) to read as follows: Sec. 271.17 Sharing of information. (a) Any information obtained or used in the administration of a State program shall be available to EPA upon request without restriction. If the information has been submitted to the State under a claim of confidentiality, the State must submit that claim to EPA when providing information under this subpart. Any information obtained from a State and subject to a claim of confidentiality will be treated in accordance with the regulations in 40 CFR part 2. If EPA obtains from a State information that is not claimed to be confidential, EPA may make that information available to the public without further notice. 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. 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. * * * * * 32. Section 271.132 is amended by revising paragraph (a) to read as follows: Sec. 271.132 Sharing of information. (a) Any information obtained or used in the administration of a State program shall be available to EPA upon request without restriction. If the information has been submitted to the State under a claim of confidentiality, the State must submit that claim to EPA when providing information under this subpart. Any information obtained from a State and subject to a claim of confidentiality will be treated in accordance with the regulations in 40 CFR part 2. If EPA obtains from a State information that is not claimed to be confidential, EPA may make that information available to the public without further notice. 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. 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. * * * * * PART 281--[AMENDED] 33. The authority citation for part 281 continues to read as follows: Authority: Sections 2002, 9004, 9005, 9006 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. 6912, 6991 (c), (d), (e). 34. Section 281.43 is amended by revising paragraph (a)(1) to read as follows: Sec. 281.43 Sharing of information. (a) * * * (1) Any information submitted to the State under a claim of confidentiality. The State must submit that claim to EPA when providing such information. 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. 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. Any information obtained from a State and subject to a claim of confidentiality will be treated in accordance with federal regulations in 40 CFR part 2; and * * * * * PART 350--[AMENDED] 35. The authority citation for part 350 continues to read as follows: Authority: 42 U.S.C. 11042, 11043 and 11048 Pub. L. 99-499, 100 Stat. 1747. 36. Section 350.23 is amended by revising paragraph (b)(3) and removing paragraph (b)(4) to read as follows: Sec. 350.23 Disclosure to authorized representatives. * * * * * (b) * * * (3) No information shall be disclosed under this Sec. 350.23(b) until each affected submitter has been furnished notice (by letter, Federal Register, or other means) of the contemplated disclosure by the EPA program office and has been afforded a period found reasonable by that office (not less than 5 working days) to submit its comments. Such notice shall include a description of the information to be disclosed, the identity of the contractor, subcontractor or grantee, and the purposes to be served by the disclosure. The office preparing the notice must respond in writing to all comments submitted by affected businesses. PART 403--[AMENDED] 37. The authority citation for part 403 continues to read as follows: Authority: Sec. 54(c)(2) of the Clean Water Act of 1977 (Pub. L. 95-217), sections 204(b)(1)(C), 208(b)(2)(C)(iii), 301(b)(1)(A)(ii), 301(b)(2)(A)(ii), 301(b)(2)(C), 301(h)(5), 301(i)(2), 304(e), 304(g), 307, 308, 309, 402(b), 405 and 501(a) of the Federal Water Pollution Control Act (Pub. L. 92-500) as amended by the Clean Water Act of 1977 and the Water Quality Act of 1987 (Pub. L. 100-4). 38. Section 403.14 is amended by revising paragraph (a) to read as follows: Sec. 403.14 Confidentiality. (a) EPA Authorities. In accordance with 40 CFR part 2, any information submitted to EPA pursuant to these regulations may be claimed as confidential by the submitter. Any such claim must be asserted at the time of submission in the manner prescribed in the application form or instructions, or, in the case of other submission, by stamping the words ``confidential business information'' on each page containing such information. If no claim is made at the time of submission, EPA may make the information available to the public without further notice. 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. 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. If a claim is asserted, the information will be treated in accordance with the procedures in 40 CFR part 2 (Public Information). * * * * * PART 704--[AMENDED] 39. The authority citation for part 704 is revised to read as follows: Authority: 15 U.S.C. 2607(a) and 2613. 40. Section 704.7 is amended by revising paragraphs (a) and (d) introductory text to read as follows: Sec. 704.7 Confidential business information claims. (a) Any person submitting a notice under this rule may assert a business confidentiality claim covering all or any part of the information. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. Any information covered by a claim will be disclosed by EPA only to the extent and by means of the procedures set forth in part 2 of this chapter. * * * * * (d) In submitting a claim of confidentiality, a senior management official, as defined in 40 CFR 2.306(a)(7), attests to the truth of the following four statements concerning all the information claimed confidential: * * * * * 41. Section 704.219 is amended by adding paragraph (c)(2) and revising paragraph (d) to read as follows: Sec. 704.219 Confidential business information claims. * * * * * (c) * * * (2) A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all reports containing confidentiality claims. (d) Submitters must substantiate all claims of confidentiality at the time the submitter asserts the claim (i.e., when the reporting form is submitted). A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all substantiations of claims of confidentiality. Failure to provide substantiation of a claim at the time the submitter submits the reporting form will result in a waiver of the confidentiality claim, and the information may be disclosed to the public without further notice to the submitter. * * * * * PART 707--[AMENDED] 42. The authority citation for part 707 is revised to read as follows: Authority: 15 U.S.C. 2611(b), 2612 and 2613. 43. Section 707.75 is amended by revising paragraph (a) to read as follows: Sec. 707.75 Confidentiality. (a) A person may assert a claim of confidentiality for any information which is submitted to EPA in a notice. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all claims of confidentiality. * * * * * PART 710--[AMENDED] 44. The authority citation for part 710 is revised to read as follows: Authority: 15 U.S.C. 2607(a) and 2613. 45. Section 710.7 is amended by revising paragraph (b) to read as follows: Sec. 710.7 Confidentiality. * * * * * (b) Any claims of confidentiality must accompany the information at the time it is submitted to EPA. The claims must appear on the form on which the information is submitted to EPA and in the manner prescribed on the form. In addition, any claims of confidentiality must be substantiated at the time the information is submitted to EPA in the manner specified in the form instructions. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all claims of confidentiality and substantiations. * * * * * 46. Section 710.38 is amended by revising paragraph (a) and the introductory text of paragraph (c)(1) to read as follows: Sec. 710.38 Confidentiality. (a) Any person submitting information under this subpart may assert a business confidentiality claim for the information. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. The procedures for asserting confidentiality claims are described in the instruction booklet identified in Sec. 710.39. Information claimed as confidential in accordance with this section and those instructions will be treated and disclosed in accordance with the procedures in part 2 of this chapter. * * * * * (c) * * * (1) The person must submit with the report detailed written answers to the following questions signed and dated by a senior management official, as defined in 40 CFR 2.306(a)(7). * * * * * PART 712--[AMENDED] 47. The authority citation for part 712 is revised to read as follows: Authority: 15 U.S.C. 2607(a) and 2613. 48. Section 712.15 is amended by revising paragraph (b) to read as follows: Sec. 712.15 Confidentiality. * * * * * (b) A senior management official, as defined in 40 CFR 2.306(a)(7), must certify to the validity of the claim of confidentiality asserted for information reported under this part, as specified on the reporting form. * * * * * PART 716--[AMENDED] 49. The authority citation for part 716 is revised to read as follows: Authority: 15 U.S.C. 2607(d) and 2613. 50. Section 716.55 is amended by adding paragraphs (a)(5) and (a)(6) to read as follows: Sec. 716.55 Confidentiality claims. (a) * * * (5) Any respondent who wishes to assert a claim of confidentiality for chemical identity must substantiate such claim in accordance with 40 CFR 2.306(d)(2). A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all substantiations. If no claim of confidentiality for chemical identity accompanies the submission or if the substantiation required under this paragraph (a)(5) is not submitted at the time of assertion of the claim, EPA will deem the claim for chemical identity waived and may make the identity public without further notice to the submitter. (6) A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all submissions containing confidentiality claims. * * * * * PART 717--[AMENDED] 51. The authority citation for part 717 is revised to read as follows: Authority: 15 U.S.C. 2607(c) and 2613. 52. Section 717.19 is amended by adding paragraphs (c)(5) and (c)(6) to read as follows: Sec. 717.19 Confidentiality. * * * * * (c) * * * (5) Any respondent who wishes to assert a claim of confidentiality for chemical identity must substantiate such claim in accordance with 40 CFR2.306(d)(2). A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all substantiations. If no claim of confidentiality for chemical identity accompanies the submission or if the substantiation required under this subparagraph is not submitted at the time of assertion of the claim, EPA will deem the claim for chemical identity waived and may make the identity public without further notice to the submitter. (6) A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all submissions containing confidentiality claims. PART 720--[AMENDED] 53. The authority citation for part 720 continues to read as follows: Authority: 15 U.S.C. 2604, 2607 and 2613. 54. Section 720.80 is amended by adding paragraph (b)(3) to read as follows: Sec. 720.80 General provisions. * * * * * (b) * * * (3) A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all notice forms containing any claims of confidentiality. * * * * * 55. Section 720.85 is amended by revising paragraph (b)(3)(iv), introductory text, to read as follows: Sec. 720.85 Chemical identity. * * * * * (b) * * * (3) * * * (iv) Provide a detailed written substantiation of the claim, signed by a senior management official, as defined in 40 CFR 2.306(a)(7), by answering the following questions: * * * * * 56. Section 720.90 is amended by adding a sentence after the first sentence of paragraph (b)(2) to read as follows: Sec. 720.90 Data from health and safety studies. * * * * * (b) * * * (2) Claims applicable to period after commencement of manufacture or import for commercial purposes. * * * A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign such reassertions and substantiations of claims of confidentiality for chemical identity. * * * * * PART 723--[AMENDED] 57. The authority citation for part 723 is revised to read as follows: Authority: 15 U.S.C. 2604 and 2613. 58. Section 723.50 is amended by revising paragraph (k)(1) to read as follows: Sec. 723.50 Chemical substances manufactured in quantities of 1,000 kilograms or less per year. * * * * * (k) Confidentiality. (1) If the manufacturer submits to EPA under this section information which it claims to be confidential business information, the manufacturer must clearly identify the information at the time of submission to EPA by bracketing, circling, or underlining it and stamping it with ``CONFIDENTIAL'' or some other appropriate designation. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. Any information so identified will be treated in accordance with the procedures in part 2 of this chapter. Any information not claimed as confidential at the time of submission may be made available to the public without further notice. * * * * * 59. Section 723.175 is amended by revising paragraph (k) to read as follows: Sec. 723.175 Chemical substances used in or for the manufacture or processing of instant photographic and peel-apart film articles. * * * * * (k) Confidentiality. If the manufacturer submits to EPA under paragraph (i) or (j) of this section information which it claims to be confidential business information, the manufacturer must clearly identify the information at the time of submission to EPA by bracketing, circling, or underlining it and stamping it with ``CONFIDENTIAL'' or some other appropriate designation. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. Any information so identified will be treated in accordance with the procedures in part 2 of this chapter. Any information not claimed as confidential at the time of submission will be made available to the public without further notice to the submitter. * * * * * PART 750--[AMENDED] 60. The authority citation for part 750 is revised to read as follows: Authority: 15 U.S.C. 2605 and 2613. 61. Section 750.16 is revised to read as follows: Sec. 750.16 Confidentiality. The Agency encourages the submission of nonconfidential information by petitioners and commenters. The Agency does not wish to have unnecessary restrictions on access to the rulemaking record. However, if a petitioner or commenter believes that he can only state his position through the use of information claimed to be confidential, he may submit it. Such information must be separately submitted for the rulemaking record and marked ``confidential'' by the submitter. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. For information claimed to be confidential, the Agency will list only the date and the name and address of the petitioner or commenter in the public file, noting that the petitioner or commenter has requested confidential treatment. The information claimed to be confidential will be placed in a confidential file. A petitioner must also file a nonconfidential petition with a nonconfidential summary of the confidential information to be placed in the public file. Similarly, a commenter must supply a nonconfidential summary of the information claimed to be confidential to be placed in the public file. Any information not marked as confidential will be placed in the public file. Information marked as confidential will be treated in accordance with the procedures in part 2, subpart B of this chapter. 62. Section 750.36 is revised to read as follows: Sec. 750.36 Confidentiality. EPA encourages the submission of non-confidential information by petitioners and commenters. EPA does not wish to have unnecessary restrictions on access to the rulemaking record. However, if a petitioner or commenter believes that he can only state his position through the use of information claimed to be confidential, he may submit it. Such information must be separately submitted for the rulemaking record and marked ``confidential'' by the submitter. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. For information claimed to be confidential, EPA will list only the date and the name and address of the petitioner or commenter in the public file, noting that the petitioner or commenter has requested confidential treatment. The information claimed to be confidential will be placed in a confidential file. A petitioner must also file a non-confidential petition with a non-confidential summary of the confidential information to be placed in the public file. Similarly, a commenter must supply a non- confidential summary of the information claimed to be confidential to be placed in the public file. Any information not marked as confidential will be placed in the public file. Information marked confidential will be treated in accordance with the procedures in part 2, subpart B of this chapter. PART 790--[AMENDED] 63. The authority citation for part 790 is revised to read as follows: Authority: 15 U.S.C. 2603 and 2613. 64. Section 790.7 is amended by revising paragraphs (a), (b) and (c), introductory text, to read as follows: Sec. 790.7 Confidentiality. (a) Any person subject to a consent agreement or test rule under section 4 of the Act may assert a claim of confidentiality claim for certain information submitted to EPA in response to the consent agreement or test rule. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all business confidentiality claims. Any information claimed as confidential will be treated in accordance with the procedures in part 2 of this chapter and section 14 of the Act. Failure to assert a claim of confidentiality at the time the information is submitted will result in the information being made available to the public without further notice to the submitter. (b) A claim of confidentiality must be asserted by circling or otherwise marking the specific information claimed as confidential and designating it with the words ``confidential business information,'' ``trade secret,'' or another appropriate phrase indicating its confidential character. Any respondent who wishes to assert a claim of confidentiality for chemical identity must substantiate such claim in accordance with 40 CFR 2.306(d)(2). A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all substantiations. If no claim of confidentiality for chemical identity accompanies the document submission or if the substantiation required under this paragraph (b) is not submitted at the time of assertion of the claim, EPA will deem the claim for chemical identity waived and may make the identity public without further notice to the submitter. (c) If a person asserts a claim of confidentiality for study plan information described in Sec. 790.50(c)(1) (iii)(D), (iv), (v), and (vi) and Sec. 790.62(b) (6), (7), (8), (9) and (10), the person must provide a detailed written substantiation of the claim by answering the questions in this paragraph. A senior management official, as defined in 40 CFR 2.306(a)(7), shall sign all substantiations. Failure to provide written substantiation at the time the study plan information is submitted will be considered a waiver of the claim of confidentiality, and the study plan information will be disclosed to the public without further notice. * * * * * [FR Doc. 94-28146 Filed 11-22-94; 8:45 am] BILLING CODE 6560-50-P