most cases, and notes that more stringent protective measures may be taken in connection with individual contracts.

74. Comment-Information should be disclosed to state or local governmental agencies under proposed § 2.301 (h) only if the affected business consents or if the state or local agency agrees that the information shall not be further disclosed and that state or local public information acts shall not apply to the information.

Response The Administrator disagrees with the comment. Many of the statutes for which EPA has the primary Federal responsibility (including the Clean Air Act) envision close working relationships between EPA and state and local pollution control agencies, and such statutes often assign significant responsibilities to state and local agencies. EPA desires to be able to provide such agencies with information it has which would be useful to them. However, the Administrator recognizes the fact that the other provisions of this subpart would afford inadequate protection to businesses if disclosure of information to state and local agencies were made without attention to the treatment that would be afforded to such information by them. Accordingly, the rule as promulgated below has been modified to provide that information may be disclosed to state or local agencies under § 2.301 (h) only if the state or locality itself could have required the business to disclose the information, or if the state or locality has shown to EPA's satisfaction that the information will be adequately protected. 75. Comment-Various commenters raised the same points with respect to the definition of "effluent data" in proposed § 2.302(a) (2) as they raised with respect to the definition of "emission data."

Response-See Responses 52 through 61.

76. Comment-Various commenters raised the same points with respect to release of information relevant to a matter in controversy in a proceeding under proposed §§ 2.302 (g), 2.303(g), and 2.304 (g) as they raised with respect to proposed § 2.301 (g).

Response-See Responses to Comments 62 through 68.

77. Comment-Various commenters raised the same points with respect to release of information to authorized representatives under proposed §§ 2.302 (h) and 2.304 (h) as they raised with respect to proposed § 2.301 (h). Response-See Responses to Comments 69 through 74.

78. Comment-Proposed § 2.307 (g), which would have established special substantive criteria for use in connection with information obtained in applications for registration of pesticides under the Federal Insecticide, Fungicide and Ro. denticide Act, as amended (FIFRA), 7 U.S.C. 136 et seq., would exceed the Administrator's authority and violate 7 U.S.C. 136h. Proposed § 2.307 (g) would deny confidential treatment to certain categories of research data and related information, but 7 U.S.C. 136h, it is asserted, requires confidential treatment for some of that data. Confidentiality determinations should be made only on a case-by-case basis.

Response The Administrator disagrees with this comment. However, for reasons unrelated to the comment, the special substantive criteria have been deleted from § 2.307. This action has been taken because under P.L. 94–140. (November 28, 1975), 89 Stat. 751, the Administrator may not promulgate regulations which implement FIFRA without first submitting the regulations to an external review process. In view of the delay that would be involved in obtaining such review, the provisions concerning substantive criteria have been deleted. (On March 5, 1976, the General Counsel issued an interpretative determination concerning the entitlement of such information to confidential treatment.)

In addition to the changes to the proposed rule which are discussed in the Comments and Responses above, other noteworthy changes are:

(1) The definition of "entitled to confidential treatment" in proposed § 2.201 (f) has been deleted as unnecessary.

(2) Definitions of "EPA office" "EPA legal office," and "working day" have been added to § 2.201.

(3) Section 2.202 has been modified to emphasize the need for alertness to the possibility that different types of information within a single document may require different treatment.

(4) Section 2.204(b) has been simplified by deletion of language which concerned the effect of a prior determination holding that an item of information is not entitled to confidential treatment. The treatment of such information is covered by § 2.204 (d) (2).

(5) The rule has been modified in several places to emphasize the fact that two or more businesses may have an interest in preserving the confidentiality of the same item of information, and that it may be necessary to resolve separately the confidentiality claims of each business. See §§ 2.204 (c) (1), 2.204(d), and 2.205(d) (3).

(6) The rule has been modified to acknowledge that a business may desire confidential treatment of an item of information only for a stated period, after which it would not object to public disclosure of the information. See §§ 2.203 (b), 2.204 (e) (4) (ii), 2.205(d) (2), 2.205(e), and 2.205 (f) (1) (ii).

(7) The requirement that information must bear a confidentiality claim when submitted if waiver of the claim is to be avoided will apply to information received on or after the effective date of the rule, rather than only to information received on or after the 60th day the rule's effective date. This change is justified by the fact that a claim will be determined to have been waived only if the business first had been warned specifically that it must assert its claim at the time of submission of the information.

(8) Section 2.204 (c) has been modified to indicate that when a request under 5 U.S.C. 552 is pending and EPA must inquire whether a business desires to assert a confidentiality claim, any claim in response to that inquiry must be made not later than one working day after the inquiry is made. The Administrator has determined that this change will not impose undue burdens on businesses, because of the ease with which a claim may be asserted and the business's opportunity to designate a representative for the purpose of handling such inquiries (see § 2.213). (9) Changes have been made in several places in the rule to indicate that although various deadlines must be met when there is pending a request for information under 5 U.S.C. 552, a less rigid timetable may be applied when no such request is pending.

(10) Section 2.204 (e) of the rule has been modified to conform the list of topics to be addressed by a business in its comments more closely to the substantive criteria under § 2.208.

(11) Section 2.205 (f) has been modified to confine to essentials the information which an EPA office must forward to the EPA legal office.

(12) Section 2.205(a) has been modified to provide a timetable for issuance of a final determination by an EPA legal office after a "procedural" denial of a request under 5 U.S.C. 552.

(13) Section 2.205 (h) has been modified to more clearly set forth the procedure by which an EPA legal office may overrule or modify an earlier determination holding that an item of information is entitled to confidential treatment.

(14) A number of changes have been made to § 2.307 and § 2.308, designed to simplify their application and increase the extent to which they parallel language in other sections of the subpart.

(15) Section 2.309 has been rewritten to eliminate unneeded elaborateness and increase the extent to which the section parallels other provisions of the subpart. [FR Doc.76-25620 Filed 8-31-76;8:45 am]

[Exhibit 29]

EPA'S PROPOSED RULES UNDER TOXIC SUBSTANCES CONTROL ACT

[Federal Register, Aug. 2, 1977]

ENVIRONMENTAL PROTECTION AGENCY

[40 CFR Parts 700 and 710]

[OTS-081002; FRL 764–1]

TOXIC SUBSTANCES CONTROL

General Provisions and Inventory Reporting Requirements; Supplemental Notice; Public Meeting

Agency: Environmental Protection Agency.

Action: Proposed Rules; Notice of Public Meeting.

Summary: This notice reproposes the inventory reporting regulations first proposed on March 9, 1977 in the Federal Register and supplemented thereafter. Specifically, these reproposed regulations would require some manufacturers:

(1) To report the identity of each chemical substance manufactured (or imported) for a commercial purpose and the site of such manufacture;

(2) To estimate the amount of each such chemical substance manufactured or imported at each site;

(3) To indicate whether each such chemical substance is manufactured and used only within one site; and

(4) To indicate whether the respondent is a manufacturer, processor, and/or importer of each such chemical substance.

In addition, these reproposed regulations would authorize certain other persons to report such information at their discretion.

Dates: Written comments must be received on or before September 16, 1977. EPA will hold a public meeting in Washington, D.C. on August 24, 1977 to provide an opportunity for oral comments. Details are provided below.

Address: Comments should be addressed to the Federal Register Section (WH557), Office of Toxic Substances, Attention: Vicki Briggs, Environmental Protection Agency, 401 M Street SW., Washington, D.C. 20460. Comments should be filed in triplicate and bear the identifying notation OTS-081002. All written comments filed pursuant to this notice will be available for public inspection at that office from 8:30 a.m. to 4:00 p.m. Monday through Friday.

For further information contact: Mr. John Ritch, Office of Industry Assistance, Office of Toxic Substances (TS-788), Environmental Protection Agency, 401 M Street, SW., Washington, D.C. 20460, 202–755–0535.

Supplementary information: These regulations are proposed under the authority of subsection 8(a) of the Toxic Substances Control Act (90 Stat. 2003; 15 U.S.C. 2601 et seq.; hereinafter referred to as TSCA).

On March 9, 1977 EPA first published in the Federal Register (42 FR 13130) proposed inventory reporting regulations to govern reporting of chemical substances for inclusion on an inventory of chemical substances required by subsection 8(b) of TSCA. On April 12, 1977, EPA published a supplemental notice of proposed rulemaking in the Federal Register (42 FR 19298) providing additional information pertaining to the proposed inventory regulations. This notice set forth instructions for use of a Candidate List of Chemical Substances and specified minerals which EPA proposed to include in the inventory of chemical substances. On April 28, 1977, EPA published a notice of availability of the Candidate List of Chemical Substances for use in reporting chemicals for inclusion on the inventory (42 FR 21639). In addition, on July 8, 1977, the Agency published a notice to amend the procedures for securing a copy of the Candidate List on computer-readable tape (42 FR 35183).

On April 18, 1977, EPA held a public meeting in Washington, D.C. to provide interested persons an opportunity to comment publicly on the proposed regulations. In addition, approximately 200 persons have submitted written comments on the proposed regulations. Both the transcript of the public meeting and the written comments are available for inspection by the public in the Federal Register Office of the Office of Toxic Substances.

As a result of these comments, EPA has decided to repropose the inventory reporting regulations to require additional reporting by some persons and less reporting by others.

Participation in the Public Meeting

The public meeting on these proposed regulations will be on Wednesday, August 24, 1977 from 9:00 a.m. to 4:30 p.m. in the Thomas Jefferson Auditorium of the Department of Agriculture, 14th and Independence Avenue, SW., Washington, D.C. Persons who want to reserve time to present their comments at that meeting should contact Vicki Briggs at the address provided above or telephone 202426-9819. Each person may request up to 15 minutes although less time may be allotted depending upon the number of participants. EPA will make a transcript of the proceedings for public inspection.

Status of Reproposal

The record of this rulemaking will include all comments received in response to the earlier notices of proposed rulemaking as well as the comments received in response to this notice. The public is encouraged to review the earlier notices of proposed rulemaking if any questions arise concerning the context of these reproposed regulations. While EPA would welcome comments on any aspect of these proposed regulations, persons are encouraged to direct their comments

to the new provisions proposed here and not duplicate comments submitted earlier on other aspects of the proposed regulations. EPA will respond to all the comments submitted in response to the proposed rulemaking notices in the final inventory reporting regulations.

Modifications of Initial Reporting Requirements

The main purpose in revising the proposed approach is to use these initial reporting requirements not only to compile the inventory required by section 8(b) but also to fulfill the Congressional intent, as stated in section 2 of TSCA, that adequate data be developed for implementation of TSCA and other authorities directed to regulating risks associated with chemical substances. Although the regulations proposed on March 9, 1977 would have required manufacturers to report chemical substances manufactured for commercial purposes, the proposed approach would not have required reporting concerning production sites or the quantities produced.

In contrast to EPA's original proposal, the revised version published here would require certain manufacturers not only to identify the chemical substances in commerce but also to report where the chemical substances are manufactured and in what quantities. This information will be valuable for estimating the potential exposure to chemical substances for monitoring, control, and preventive actions. For example, plant site information would be useful in identifying possible sources of hazardous chemicals, especially in an emergency. Data on the quantities of chemical substances in commerce would enable EPA and other agencies to select substances for priority attention among the tens of thousands in commerce.

These amendments would expand the scope of the initial reporting requirements, but would limit the applicability of the requirements to those persons with establishments that are primarily engaged in the manufacture of chemical substances. Accordingly, only the approximately 20,000 establishments in the Standard Industrial Classification Major Group 28 (Basic Chemicals and Allied Products) and Group 2911 (Petroleum Refining) would be required to report each chemical substance manufactured at the production site and the volume of production. Manufacturers outside these groups would not be required to report. These latter persons could choose to report or could authorize a trade association to report to ensure chemical substances which they manufacture are included on the inventory. The hundreds of thousands of chemical processors may report during a limited period following publication of the initial inventory. EPA may require reporting by any of these manufacturers or processors as part of its phased reporting strategy under section 8(a), discussed in the following section.

Other amendments to the March 9, 1977 proposal include a requirement that manufacturers indicate whether a chemical substance is manufactured and processed solely within one site and not distributed for a commercial purpose outside that site. EPA is considering specially designating these chemical substances on the inventory and providing under section 5(a)(2) that any use of those substances for commercial purposes outside the manufacturing site would be considered a "significant new use." In addition, respondents would be required to indicate whether they manufacture, process, and/or import a chemical substance. Knowing which persons manufacture, import, or process a reported chemical substance would enable EPA to direct any future notice or requirement to appropriate persons and permit the Agency to estimate how much of a substance is manufactured domestically and how much is imported.

Various representatives of the Federal government and environmental groups have urged EPA to amend the initial reporting requirements to include reporting on uses of chemical substances. EPA recognizes the importance of obtaining use information in order to estimate exposure to a chemical substance. However, incorporating use reporting into the initial requirements would substantially delay the publication of the inventory, perhaps for more than a year after the statutory date. Premanufacture notification of new chemicals would be delayed accordingly.

For this and other reasons, EPA decided to postpone use reporting to the second phase of its reporting strategy, as described below.

Overall Strategy

By reproposing the inventory regulations, EPA recognizes that it will be unable to meet the statutory deadline for publication of the inventory in November

1977. Nonetheless, EPA believes that the proposed delay is warranted by the importance of the data base that would be generated as a foundation for implementation of TSCA. At the same time, EPA will not attempt to develop a comprehensive data base on all chemical substances through the initial reporting requirements. EPA has developed an overall strategy for data development under section 8(a) of TSCA. These initial reporting requirements are the first of three phases.

The second phase of EPA's proposed strategy will be initiated after these regulations are final this fall. In this phase, EPA will address chemical substances selected because of their concern to EPA, the Occupational Safety and Health Administration (OSHA), the Consumer Product Safety Commission (CPSC), as well as to other agencies and interested parties. Manufacturers and processors of those chemical substances may be required to submit use information, including the estimated amounts of a chemical substance manufactured or processed for each use. In addition, EPA would consider asking for information on impurities, byproducts, worker exposure, and other factors as needed for specific chemical substances or categories of chemical substances.

The third phase of EPA's reporting strategy would begin after the inventory is published in 1978. EPA would by regulation require reporting under section 8(a) for additional chemical substances selected in part on the basis of their relative production volumes as reported under the initial reporting requirements. During this phase, EPA intends to develop the data base for a larger portion of chemical substances in commerce with respect to their use, exposure and other factors. Finally, in addition to such systematic reporting, EPA anticipates that it may ask for information on certain chemical substances as needed by the Department of Labor and others in emergency situations.

In determining what information to require in each of these phases, EPA will of course review alternative sources of data such as information available under Section 308 of the Federal Water Pollution Control Act Amendments of 1972 and other authorities, and will minimize duplicative reporting requirements.

Definitions of Small Manufacturers for These Regulations Only

In proposing an expanded approach to the inventory reporting requirements, EPA would require certain manufacturers and importers to report information in addition to the identities of chemical substances in commerce. Paragraph 710.5 (d) of these proposed regulations outlines this information. Although TSCA section 8(a) provides broad authority to EPA to require information necessary for the administration of the Act, EPA may require "small manufacturers and processors" to submit only information required for compilation of the initial inventory or concerning a chemical substance which is subject to a proposed rule or order under TSCA section 4, 5, or 6. or court action under section 5 or 7.

Some of the additional information outlined in paragraph 710.5(d), such as production volume and the manufacturing sites of a chemical substance, may not be considered necessary for compilation of the initial inventory. Therefore, EPA may not be authorized to require submission of that information from "small manufacturers" under these regulations. Accordingly, EPA is proposing to define which persons qualify as "small manufacturers" for the purpose of these regulations and to exempt small manufacturers from certain of these reporting requirements.

"The definition of 'small manufacturer' proposed here is a one-time definition intended to apply solely to these regulations. Accordingly, it would only apply to manufacturers in SIC groups 28 and 2911 and to importers of chemical substances. Persons should not interpret this definition as indicative of future definitions which will be proposed for the purpose of subsequent regulations under section 8(a) of TSCA. These definitions for "small manufacturers" will take into account the burdens of complying with the future reporting and/or record-keeping requirements.

Section 8(a) (3) (B) of TSCA provides that, after consulting with the Small Business Administration, the Administrator shall by rule prescribe standards for determining the manufacturers and processors which qualify as "small manufacturers and processors." The legislative history of TSCA shows that the Senate bill contained no exemption from the reporting requirements for small manufacturers and processors. The House bill first introduced this provision because reporting and record-keeping requirements “may impose a particularly heavy burden on small manufacturers and processors" (H.R. Rep. No. 94-1341, 21-656-7827