Document zookLeKOq2roy7gn77RQKjKg3

FRIDAY, DECEMBER 23, 1977 PART VI PLAINTIFFS EXHIBIT r- KM-37 2 ENVIRONMENTAL PROTECTION AGENCY TOXIC SUBSTANCES CONTROL Inventory Reporting Requirements KMX 01186 64572 RULES AND REGULATIONS [ 6560-01] On March 9, 1977, EPA first published of TSCA. They accomplish two of the Title 40--Protection of Environment in the Federal Register (42 FR 13130) purposes contained in that section of the proposed inventory reporting regulations Act. In the first place, in accordance with CHAPTER I--ENVIRONMENTAL to govern reporting of chemical sub section 8(a) (1) of the Act, they require PROTECTION AGENCY stances required by subsection 8(a) of reporting for compilation of the inven SUBCHAPTER R--TOXIC SUBSTANCES CONTROL TSCA. On April 12, 1977, EPA published tory of chemical substanees manufac a supplemental notice of proposed rule tured or processed for a commercial pur IOTS-08I002A; FRL 817-1] making in the Federal Register (42 FR pose in the United States. The Adminis PART 710--INVENTORY REPORTING REGULATIONS AGENCY: Environmental Protection Agency. 19298) providing additional information pertaining to the proposed inventory regulations. This notice set forth in structions for use of a Candidate List of Chemical Substances and specified min trator is required to compile and publish an inventory of chemical substances under section 8(b) of the Act. In the second place, under the authority of TSCA section 8(a) (1) (A), these regula ACTION: Pinal rules. . erals which EPA proposed to include in tions require reporting of production and SUMMARY: This notice promulgates the inventory reporting regulations proposed on March 9 and August 2, 1977 in the Federal Register and supplemented thereafter. Specifically, these regulations require some persons who manufacture or import chemical substances: (1) To report the identity of each chemical substance manufactured at each site of manufacture, or imported into the United States, for a commercial purpose: (2) To estimate the amount of each chemical substance manufactured at each site, or imported during calendar year 1977; and (3) To indicate whether each such chemical substance is manufactured and used only within one site. Based upon the reports of manufactur ers and importers, EPA will publish an Initial inventory of chemical substances. After publication of the initial inven tory, these regulations authorize report ing by processors of additional chemical substances. EPA will publish a revised inventory including these substances in 1979. DATES: These regulations are effective January 1, 1978. Reporting for the initial inventory by manufacturers and import ers of chemical substances will begin January 1, 1978 and end May 1, 1978. During the 210 days after publication of the initial inventory in late 1978, proces sors of chemical substances, and im porters of chemical substances as part of mixtures or articles, may report addi tional chemical substances for a revised Inventory. (NOTE: Many of the terms used in these regulations, such as "man ufacturer" and "processor" have a spe cial meaning for purposes of these regu lations. Persons should read the regula tions, especially the definition section carefully, and be sure they understand the special meanings of these terms.) the inventory of chemical substances. 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 regu lations. 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). 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). EPA is preparing to supplement the Candidate List with at least one additional list of substances. As soon as any supplementary list is avail able, EPA will publish a notice of avail ability in the Federal Register to enable persons to request copies. On August 2,1977, EPA reproposed the inventory reporting regulations. In order to provide interested persons an oppor tunity to comment publicly on the pro posed regulations, EPA held a public meeting in Washington, D.C. on August 24, 1977. A transcript of the public meet ing is available for public inspection in the Office of Toxic Substances at the ad dress provided above. Finally, on October 3, 1977, EPA published a supplementary notice to the August 2 proposal. This notice clarified the applicability of the reporting regulations to Importers and invited comment on draft reporting forms. EPA has received over 400 comments in response to the notices of proposed rule making published on March 9, August 2, and October 3, 1977. These comments were received from trade associations, business firms, environmental organiza tions, labor unions, state and federal agencies and others. Appendix A of this notice summarizes and responds to the significant Issues raised in these com ments. The major Issues that were re solved in promulgation of these final reg site information on chemical substances, which is reasonably necessary for estab lishing a profile of the chemical industry, monitoring chemical substances in the environment, and setting Agency priori ties for implementing other provisions of TSCA. In the interest of accomplishing these objectives, | 710.3(a) requires any per son who manufactured or Imported chemical substanoes during calendar year 1977 to report concerning all such sub stances if (a) thirty percent or more of the weight of the products consists of products of the types described under Standard Industrial Classification (SIC) groups 28 or 2911, or (b) if the total pounds of reportable chemical substances manufactured or imported equals one million pounds or more. In addition, any person who manufactured at a site or Imported a chemical substance in 100,000 pound quantities or greater during cal endar year 1977 must report concerning that chemical substance. By directing the reporting require ments to those persons who are signifi cantly engaged in manufacturing chem ical substances, EPA will create a profile of the chemical industry useful in future implementation of TSCA. As a minimum, the Agency will know the site of man ufacture of all chemicals manufactured in quantities greater than 100,000 pounds. Moreover, for every plant site substan tially engaged in producing chemical substances or chemical products for com mercial purposes, EPA will know the Identities of the substances manufac tured there and the relative quantities in which they are produced. As discussed further in the response to comments (Appendix A), EPA desires to minimize duplicative reporting to the extent consistent with its needs in im plementing TSCA. Manufacturers and Importers who do not meet the criteria FOR FURTHER INFORMATION CON ulations are discussed below. for required reporting do not need to re TACT: Mr. John B. Ritch, Jr., Director, Office of Industry Assistance, Office of Toxic Substances (TS-788), Environmental Protection Agency, 401 M Street, SW,, Washington, D.C. 20400, 202-755-0535. To obtain reporting forms and instruc tions, call this toll-free number 800 424-9065. ' SUPPLEMENTARY INFORMATION: The regulations are promulgated under the authority of subsection 8(a) of the Toxic Substances Control Act (90 Stat. 2003; 15 U.S.C. 2601 et seq.) hereinafter Appendix B of these regulations in cludes copies of the reporting forms for these regulations. These forms are pub lished here as samples of the official forms which will be available from EPA. These forms may not be used for report ing. The official forms, which will be dis tributed to persons Included on EPA's mailing list, each has a unique identify ing number for purposes of processing. Authority, Purpose and Scope or the Regulations . These regulations are promulgated port individually. Instead, they may re port through a trade association or rely upon another manufacturer or an im porter to report the substances for in clusion on the inventory. Further, in the interest of minimizing duplicative report ing, persons who are processors of a chem ical substance they neither manufacture nor import are not subject to the Initial reporting requirements. Persons who process or use chemical substances for commercial purposes may report those chemical substances not Included in the initial Inventory during a special report referred to as TSCA. pursuant to the authority of section 8(a) ing period. In addition, persons who lm- FEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64573 port chemical substances as a part of a mixture or article may report during the special reporting period. EPA expects to publish a revised inventory based on these additional reports sometime in fall 1979. Small Manufacturer as provided in the table at 710.5(d) (4). Since the manufacturer or importer will already be reporting the names of sub stances, the additional burden of supply ing production information in terms of large ranges should be minimal, espe cially for substances produced in signifi cant quantities. EPA will address this issue prior to pub lication of the initial inventory. Refer to comments 18 to 23/for further clarifi cation of these issues concerning im porters of chemical substances. Finally, EPA recognizes that it is In evitable, considering the large volume of Information to be compiled and trans As provided in TSCA section 8(a) and mitted, that there may be some uninten discussed in the preamble to the August 2 Reporting Schedule and Enforcement tional clerical errors in reporting. Ac proposal, EPA may require "small manu These regulations provide for publica cordingly, the note in 5-710.1 (b) of these facturers" to submit only information tion of an initial inventory based on re regulations provides that EPA does not necessary for compilation of the inven porting by manufacturers and importers intend to focus its enforcement efforts tory or concerning a chemical substance of chemical substances, followed by pub on reporting violations that are clerical which is subject to a proposed rule or lication of a revised inventory based on in nature. Instead. EPA will give priority order under TSCA section 4. 5 or 6 or reporting by processors of chemical sub to bringing actions against persons who court action under section 5 or 7. At this stances and importers of chemical sub (1) report false information, (2) report time, any person who is required to re stances as part of mixtures and articles. for inclusion on the inventory chemical port and who is a small manufacturer is Reporting for the initial inventory will substances which are excluded under only required to submit information re begin on January 1,1978, and end May 1, section 710.4(c) of these regulations, quired for compilation of the inventory. 1978. Manufacturers and importers of (3) fail to report, or (4) fail to Accordingly, any "small manufacturer" chemical substances must report, as pro maintain records documenting reported need only identify chemical substances vided in 710.3(a), during this first re information. and report certain limited information porting period. Processors are only sub Confidentiality required for purposes of the inventory. Small manufacturers are exempt from reporting production volumes and, if a small manufacturer has more than one plant site, he need not separately report for each site. Since these regulations de fine "manufacture" to include "import," the provision applies equally to "small importers." The definition of "small manufacturer or importer" proposed in August has been revised to exempt from these addi tional reporting requirements those man ufacturers and Importers with total sales of less than $5 million. This exemption, however, does not apply with respect to any chemical substance produced by a manufacturer at one site or imported in quantities equal to or greater than 100, 000 pounds during calendar year 1977. Accordingly, no manufacturer will be considered a "small manufacturer or im porter" with respect to any chemical sub stance manufactured at one site or im ported in quantities over 100,000 pounds. In deciding how to define "small man ufacturer or importer," EPA considered . both the relative burden to manufac turers and importers to submit additional information and the value of that infor mation to EPA and other federal agen cies. Under this definition, the total cost of reporting for the inventory for- the marginal small firm, in most cases, will be about 1 percent of profits. While the firms exempted under this definition rep resent nearly 80 percent of chemical firms, they account for only 4 percent of sales of chemical substances and only 6 percent of employment in SIC groups 28 and 2911. In tire interest of creating a data base that is at least complete with respect to the volumes of those chemical substances produced in substantial quantities, this definition does not exempt any manufac turer or importer from reporting the vol umes of individual substances produced in quantities of over 100,000 pounds dur ing calendar year 1977. Reporting pro duction volume will involve simply pro viding the digit that is associated with a broad range (e.g., "4" is for production ject to the second reporting period which will begin after publication of the initial inventory and end 210 days later. Thirty days after publication of the in itial inventory, premanufacture notifica tion will begin. After that date, any per son who intends to manufacture or im port (in bulk) a chemical substance not included on the inventory must submit premanufacture notice under section 5 (a)(1)(A). Processors and users of a chemical substance for a commercial purpose, and importers of a chemical sub stance as a part of a mixture or article will be able to supplement the Initial In ventory during the second reporting pe riod, as provided in 5 710.3(b). TSCA section 15(1) makes It unlawful for any person to fail or refuse to comply with the premanufacture notification re quirements of section 5. TSCA section 15(2) makes it unlawful for a person to use for a commercial purpose any sub stance which he had reason to know was manufactured in violation of section 5. Sections 15(1) and 15(2) as they relate to section 5(a)(1)(A) will not be ap plied to persons who process or use for a commercial purpose chemical substances not on the inventory or who import chemical substances as a part of a mix ture until after publication of the revised inventory. By reporting any chemical substance, not Included on the initial inventory during the second reporting period, these persons will be able to pro tect themselves from prosecution under section 15(2) with respect to the require ments of section 5(a)(1)(A) of TSCA. Importers of a chemical substance as part of a mixture or article will not be subject to premanufacture notification requirements for "new" chemical sub stances until 30 days after publication of the revised, inventory. Under these re porting requirements, persons who im port chemical substances as part of arti cles do not have to report concerning those chemical substances for the initial inventory. EPA is still considering whether importers of certain chemical substances as part of articles will be sub ject to premanufacture notification re As discussed in the preamble to the August proposal, there is an apparent conflict between section 14 and sections 8(b) and 5(a) of TSCA with respect to the inclusion of the identities of certain chemical substances on the inventory. Section 8(b) requires EPA to publish a list of "each chemical substance which Is manufactured or processed in the United States. Such list shall Include each chemical substance which any per son reports, under section 5 or subsection (a) of this section, is manufactured or processed in the United States." (em phasis added) The list has two purposes, to inform the public concerning which chemical substances are manufactured or processed for a commercial purpose and to which the public may be exposed, and to define what constitutes a "new chemical substances" for purposes of premanufacture notification require ments under section 5(a). However, sec tion 14 states that any information re ported to EPA under TSCA that is ex empt from disclosure under the Freedom of Information Act fourth exemption (5 U.S.C. 552(b)(4)) may not be disclosed except in specific circumstances set out in section 14 (a) and (b). In the absence of the requirements of section 8(b) and 5(a), EPA would pub lish an inventory that would not include the identities of specific chemical sub stances for which the fact that the par ticular substance is manufactured or processed for commercial purposes is confidential. In the absence of the re quirements of section 14, EPA would pub lish a list of all chemical substances manufactured or processed for com mercial purposes.. Since the term manu facture includes "to import", this dis cussion and the regulations apply equally to imported chemical substances. Having no explicit statutory guidance about how to resolve this conflict, EPA has attempted to balance the concerns of section 14 with those of sections 8(b) and 5(a). EPA believes that Congress did not intend manufacturers to be required to furnish EPA premanufacture notifica tion on existing chemical substances between 1 million and 10 million pounds), quirements under section 5(a)(1)(A). whose identities for purposes of the in- FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 64574 RULES AND REGULATIONS ventory have been claimed as trade Interested in distinguishing a "fishing Accordingly, TSCA requires the secret. EPA believes that Congress did expedition" by a competitor from a bona Agency to publish in the Federal Regis Intend EPA to preserve confidentiality fide inquiry concerning the identities of ter the list of documents that constitute to the maximum extent practicable with confidential chemical substances on the the record of this rulemaking. Public out impairing administration of TSCA. inventory. comments are exempt from Federal Accordingly. EPA has developed the ap Accordingly, 5 710.7(g) permits an in Register listing under section 19(a)(3) proach set forth in 710.7, and explained quiring manufacturer to submit certain and have not been listed. A full listing of in greater detail in Appendix A, Response information to establish his bona fide in the public comments is available on re to Significant Comments. The approach tent to manufacture the chemical sub quest from the Record and Hearing balances confidentiality under section 14 stance. A manufacturer is not required Clerk. In addition, those documents with the regulatory scheme of sections to establish this Intent; he can simply listed below as part of this rulemaking 8(b) and 5(a). This approach will be submit a premanufacture notification. If record are available at the Office of the used for the submission of confidential a manufacturer establishes bona fide in Record and Hearing Clerk in the Office identities for the inventory now under tent to manufacture a chemical sub of Toxic Substances. section 8(a) and subsequently under sec stance, EPA will tell the inquiring manu The factual and policy considerations tion 5(a)(1)(A). Should the approach facturer whether the chemical substance that are the basis of this rule were pub fail to achieve its stated purposes. EPA is included on the inventory as a con lished in the preambles to the March 9 will re-examine the approach and con fidential identity, and therefore, whether and August'2, 1977 proposed rules and sider alternatives. he must submit premanufacture notifica October 3, 1977 supplemental notice. In EPA will allow manufacturers, im tion under TSCA section 5(a)(1)(A). response to public comment, EPA has porters and processors to claim as confi The submitter who claimed that the prepared a document analyzing the im dential the fact that a particular chemi specific chemical identity should not ap pacts of these regulations which the Ad cal substance is manufactured or proc pear on the inventory will be required by ministrator hereby identifies under essed in the United States for commer cial purposes. The manufacturer or processor making such a claim must pro vide certain information and agree to certain provisions specified in 710.7(e) of these regulations. EPA will make a final determination concerning entitle ment to confidentiality, in accordance with EPA's procedures for handling con fidentiality of business information in 40 CFR Part 2, Subpart B (41 PR 36906, 710.7(e) (2) to agree to have available and furnish to EPA upon request certain identifying information on the chemical substance and agree that EPA may dis close to a person with a bona fide intent to manufacture the substance whether the particular chemical substance is in cluded on the inventory. Failure to fur nish this information to EPA upon re quest will be construed as a waiver of the claim of confidentiality, and the TSCA section 19(a) (3) (E) as part of the record of this rulemaking. This docu ment surveys information generally available to the public. It is entitled, "Analysis of Options for Definition of Small Business and Estimated Cost of the Initial Section 8<a) Reporting Re quirements," prepared by Arthur D. Lit tle, Inc., Cambridge, Massachusetts, con tract number 68-01-4381 (November 1977). September 1, 1976). If EPA determines that the fact the particular chemical sub stance is manufactured or processed in the United States for commercial pur poses is confidential, EPA will not place the specific chemical identity on the specific identity will be placed on the in ventory. The Agency believes that this resolution of the conflict between sec tions 5ia). 8(b), and 14 of the statute balances the equities and interests of all parties. During development of this rule, EPA has conducted two public meetings and several informal meetings attended by interested members of the public. Tran scripts of the three public meetings and minutes of several informal meetings are published Inventory. Instead, EPA will There are several other issues concern hereby included under section 19(a)(3) publish a generic chemical name in an ing confidentiality that have been raised (e) as part of this rulemaking. appendix to the inventory. by these regulations. These issues and 1. Transcript of public meeting on The generic chemical name will inform further elaboration of the above ap TSCA Inventory Reporting Regulations the public of at least the generic types of proach are discussed in Appendix A, Sig as proposed March 9, 1977--(April 18. confidential chemical substances manu nificant Comments and Responses. 1977). factured or processed for a commercial purpose in the United States. Further, the generic name will be helpful to manufac turers who consult the appendix to the Inventory to determine whether they must submit premanufacture notification under section 5(a) (1) (A) for a proposed "new" chemical substance. The generic name will alert them to the possibility that the proposed "new" chemical sub stance may be included on the inven tory under that name. The generic name will not establish a category of chemical substances for purposes of the inventory and premanufacture notification re quirements. EPA wants to avoid the anti-competi tive impacts which may arise if new en Definitions EPA wishes to emphasize that the terms used in these regulations may not be wholly consistent with the ordinary usage of such terms. For example, the term "manufacturer" includes importers. As used in these regulations, the terms "manufacturer" and "processor" may both apply to a person who normally would consider himself one or the other. "Intermediate" refers only to those in termediates which are isolated or re moved from the equipment in which they are manufactured. Persons should be sure they understand the special meanings of the terms used for purposes of these reg ulations. 2. Transcript of public meeting on TSCA Inventory Reporting Regulations, as proposed August 2, 1977--August 24, 1977). Informal meetings jvere held with in terested members of industry, labor, and environmental groups on the following dates. Minutes of these meetings are in cluded in the record. December 13,1978 December 21, 1976 January 6, 1977 January 7, 1977 January 19,1977 April 14, 1977 April 21, 1977 April 27, 1977 May 6, 1977 May 17, 1977 June 9, 1977 August 4, 1977 August 18. 1977 September 30, 1977 October 6,1977 October 31,1977 Transcripts of the informal meetings trants into an existing market were re Official Record of Rulemaking held May 6 (with the American Import quired to give premanufacture notifica tion while the existing manufacturer who claimed the identity of the chemical substance as confidential was able to continue to manufacture it. If a manu facturer is required to give premanu facture notification on a chemical sub stance. he cannot manufacture the sub stance for at least the 90-day notice period. This delay may be considerably longer if a testing rule under section 4 requires the manufacturer to develop TSCA section 19(a)(3) defines the term "rulemaking record" for the pur poses of judicial review of a section 8(a) regulation as (1) the rule being reviewed, (2) any written submission of interested parties respecting the promulgation of such rule and (3) any other information which the Administrator considers to be relevant to such rule and which the Ad ministrator identified on or before the date of the promulgation of such rule, in a notice published in the Federal ers Association) and May 17 (concern ing confidentiality) are also included in the record. In addition, during the development of these rules. Agency staff members had phone conversations with interested members of the public. Phone conversa tions relevant to this rulemaking are in cluded in the record of this rulemaking. A listing of these materials is available upon request from the Record and Hear and submit certain test data. EPA is also Register. ing Clerk. FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64575 Effective Date These regulations shall take effect on January 1, 1978. In accordance with 5 U.S.C. 553(d)(3), the Administrator finds for good cause that the effective date of these regulations will not be post poned until 30 days after publication in the Federal Register. TSCA section 8(b) provides that a chemical substance may be included on the inventory only if it was manufactured or processed within three years before the effective date of these regulations. If these regulations are effective on January 1, 1978, any chemical substance manufactured or processed for a commercial purpose since January 1. 1975 may be reported for the inventory. The January 1, 1975 date has been relied on by the industry in pre paring for reporting under these regula tions. Any greater delay in the effective ness of these regulations would interfere with orderly and timely reporting for the inventory. Economic Impact Analysis Statement EPA has determined that the regula tion does not require the compilation of an Economic Impact Analysis Statement as required by Executive Order 11821. This determination is based on the cost estimate prepared by Arthur D. Little, Inc., as part of their report, "Analysis of Options for Definition of Small Business and Estimated Cost of the Initial Sec tion 8(a) Reporting Requirements," i November 1977), which is part of the rulemaking record. The total cost to in dustry of complying with the require ments of this regulation does not exceed S15 million. Accordingly, EPA has not performed an Economic Impact Analysis because the cost does not exceed the criteria for a major Agency action. The Environmental Protection Agency has determined that this document does not contain a major proposal requiring preparation of an Economic Impact Analysis Statement Under Executive Order 11821 and OMB Circular A-107. Dated: December 12, 1977. Douglas Costle, Administrator. Part 710 is established to read as fol lows : Sec. 710.1 710.2 710.3 710.4 710.5 710.6 710.7 710.8 Scope and compliance, Definitions. Applicability: Reporting for the ini tial and revised Inventory. Scope of the inventory. How to report for the inventory. When to report. Confidentiality. Effective date. Althority: Subsection 8fa>, Toxic Sub stances Control Act (TSCA) (90 Stat. 2003, '.5 U.S.C. 2607(a)) ). ^ 7 IP. I Scope and compliance. re This Part establishes regulations governing reporting by certain persons who manufacture, import, or process chemical subsances for commercial pur poses under section 8(a) of the Toxic Substances Control Act (15 U.S.C. 2607 1 a <. Section 8fa) authorizes the Admin istrator to require reporting of informa tion necessary for administration of the Act and requires EPA to issue regulations for the purpose of compiling an inven tory of chemical substances manufac tured or processed for a commercial pur pose, as required by section 8(b) of the Act. Following an initial reporting pe riod. EPA will publish an initial inven tory of chemical substances manufac tured or Imported for commercial pur poses. After a supplemental reporting period, EPA will publish a revised in ventory including those additional chem ical substances processed or used for commercial purposes or imported for commercial purposes as a part of a mix ture or article. Further, in accordance with section.8(b), EPA periodically will amend the inventory to. include new chemical substances which are manufac tured or imported for a commercial pur pose and reported under section 5(a)(1) of the Act. EPA also will revise the cate gories of chemical substances and make other amendments as appropriate. (b) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under these reporting regulations. In addition, section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by these regulations. Section 16 provides that any person who violates a provision of section 15 is lia ble to the United States for a civil pen alty and may be criminally prosecuted. Pursuant to section 17, the Government may seek judicial relief to compel sub mission of section 8(a) information and to otherwise restrain any violation of section 15. Note.--As a matter of traditional Agency policy, EPA does not Intend to concentrate its enforcement efforts on Insignificant cleri cal errors in reporting. (c) Each person who reports under these regulations shall maintain records that document information reported un der these regulations and, in accordance with the Act, permit access to, and the copying of such records by EPA officials. 710.2 Definitions. For the purposes of this Part: (a) The following terms shall have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued under such Act: "cosmetic," "device," "drug," "food," and "food additive." In addition, the term "food" includes poultry and poultry prod ucts, as defined in the Poultry Products Inspection Act. 21 U.S.C. 453 et seq.: meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 et seq.: and eggs and egg prod ucts, as defined in the Egg Products In spection Act. 21 U.S.C. 1033 et seq. (b) The term "pesticide" shall have the meaning contained in the Federal Insecticide. Fungicide, and Rodenticide Act. 7 U.S.C. 136 et seq., and the regula tions issued thereunder. (c) The following terms shall have the meaning contained in the Atomic Energy Act of 1954. 42 U.S.C. 2014 et seq., and the regulations issued thereunder: "by product material," "source material," and "special nuclear material." (d) "Act" means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. (e) "Administrator" means the Ad ministrator of the U.S. Environmental Protection Agency, any employee or au thorized representative of the Agency to whom the Administrator may either herein or by order delegate his authority to carry out his functions, or any other person who shall by operation of law be authorized to carry out such functions. (f) An "article" is a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or de sign during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in 9 710.4 (d) (5); except that fluids and particles are not considered articles regardless of shape or design. (g) "Byproduct" means a chemical substance produced without separate commercial intent during the manufac ture or processing of another chemical substance(s) or mixture(s). (h) "Chemical substance" means any organic or inorganic substance of a particular molecular identity, including any combination of such substances oc curring in whole or in part as a result of a chemical reaction or occurring in na ture, and any chemical element or un combined radical; except that "chemical substance" does not include: (1) Any mixture, . (2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide, (3) Tobacco or any tobacco product, but not including any derivative prod ucts, (4) Any source material, special nu clear material, or byproduct material. (5) Any pistol, firearm, revolver, shells, and cartridges, and (6) Any food, food additive, drug, cos metic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. (i) "Commerce" means trade, traffic, transportation, or other commerce (1) between a place in a State and any place outside of such State, or (2) which af fects trade, traffic, transportation, or commerce described in clause (1). (j) "Distribute in commerce" and "distribution in commerce" when used to describe an action taken with respect to a chemical substance or mixture or article containing a substance or mix ture, mean to sell or the sale of, the sub stance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce. FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 64576 RULES AND REGULATIONS ik) "EPA" means the US. Environ agency, or Instrumentality of the Fed mental Protection Agency. eral government (1) "Importer" means any person who (t) "Process" means the preparation imports any chemical substance or any of a chemical substance or mixture, af chemical substance as part of a mixture ter its manufacture, for distribution in or article into the customs territory of commerce (1) in the same form or phys the U.S. and includes: (1) The person ical state as, or in a different form or primarily liable for the payment of any physical state from, that in which it was duties on the merchandise, or <2> an au received by the person so preparing such thorized agent acting on his behalf (as substance or mixture, or (2) as part of a defined in 19 CPR 1.11). mixture or article containing the chemi ' m > "Impurity" means a chemical sub cal substance or mixture. stance which is unintentionally present (u) "Process for `commercial pur with another chemical substance. poses' " means to process (1) for dis n> "Intermediate" means any chemi tribution in commerce, including for cal substance (1) which is intentionally test marketing purposes, or i2> for use removed from the equipment in which it as an intermediate. is manufactured, and (2> which either is v) "Processor" means any person consumed in whole or in "part in chemi who processes a chemical substance or cal reaction!s) used for the intentional mixture. manufacture of other chemical sub (w) "Site" means a contiguous prop stances) or mixture(s), or is intention erty unit. Property divided only by a ally present for the purpose of altering public right-of-way shall be considered the rate of such chemical reaction (s). one site. There may be more than one Note.--The "equipment In which it was manufacturing plant on a single site. manufactured" Includes the reaction vessel For the purposes of imported chemical in which the chemical substance was manu substances, the site shall be the business factured and other equipment which is address of the importer. strictly ancillary to the reaction vessel, and any other equipment through which the chemical substance may flow during a con < x > "Small manufacturer or importer" means a manufacturer or importer tinuous flow process, but does not include whose total annual sales are less than tanks or other vessels in which the chemical-, $5,000,000. based upon the manufac substance Is stored after its manufacture. turer's or importer's latest complete fis iO) "Manufacture" means to produce or manufacture in the United States or import into the customs territory of the United States. (p) "Manufacture or import `for com mercial purposes' " means to manufac ture or import: (1) For distribution in commerce, in cluding for test marketing purposes, or (2) For use by the manufacturer, in cluding for use as an intermediate. (q) "Mixture" means any combina tion of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, cal year as of January 1. 1978, except that no manufacturer or importer is a "small manufacturer or importer" with respect to any chemical substance which such person manufactured at one site or imported in quantities greater than 100,000 pounds during calendar year 1977. In the case of a company which is owned or controlled by another com pany. total annual sales shall be based on the total annual sales of the owned or controlled company, the parent com pany, and all companies owned or con trolled by the parent company taken together. the result of a chemical reaction; ex Note.--The purpose of the exception to cept that "mixture" does include (1) the definition Is to ensure that manufac any combination which occurs. In whole or in part, as a result of a chemical reac tion if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined and if, after the effective date of premanufacture no tification requirements, none of the chemical substances comprising the combination is a new chemical sub stance, and <2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water. < r) "New chemical substance" means any chemical substance which is not In cluded in the inventory compiled and published under subsection 8'b) of the Act. <s) "Person" means any natural or juridicial person including any individ ual, corporation, partnership, or asso turers and Importers report production vol umes for all chemical substances which they manufactured at one site or imported In quantities equal to or greater than 100.000 pounds during calendar year 1977. <y> "Small quantities for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, in cluding any such research or analysis for the development of a product" (hereinafter sometimes shortened to "small quantities for research and de velopment") means quantities of a chemical substance manufactured. Im ported, or processed or proposed to be manufactured. Imported, or processed that < 1) are no greater than reasonably necessary for such purposes and (2) af ter the publication of the revised in ventory, are used by, or directly under the supervision of, a technically quali fied individual's). ciation, any State or political subdivi Note.--Any chemical substances manu sion thereof, or any municipality, any factured. imported or processed in quantities of less than 1,000 pounds annually shall be Interstate body and any department. presumed to be manufactured. Imported, or processed for research and development pur poses. No person may report for the inventory any chemical substance in such quantities unless that person can certify that the sub stance was not manufactured. Imported, or processed solely in small quantities for re search and development, as defined in this section. <z) "State" means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or pos session of the United States. (aa) "Technically qualified individual" means a person (1) who because of his education, training, or experience, or a combination of these factors, is capable of appreciating the health and environ mental risks associated with the chemi cal substance which is used under his supervision. (2) who is responsible for enforcing appropriated methods of con ducting scientific experimentation, anal ysis, or chemical research in order to minimize such risks, and (3) who is re sponsible for the safety assessments and clearances related to the procurement, storage, use. and disposal of the chemical substance as may be appropriate or re quired within the scope of conducting the research and development activity. The responsibilities in clause (3) of this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in clause (1) of this paragraph. (bb) "Test marketing" means the dis tribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor to no more than a defined number of potential customers to explore market capability in a competitive situation during a pre determined testing period prior to the broader distribution of that chemical substance, mixture or article in com merce. _ (cc) "United States," when used in the geographic sense, means all of the States, territories, and possessions of the United States. 710.3 Applicability i Reporting for the initial inventory and revised inven tory: Mlio must report; who should report. Based on reports from manufacturers and some importers of chemical sub stances, EPA will compile an Initial in ventory of chemical substances manu factured for commercial purposes. Para graph (a) of this section identifies who must report for this initial inventory and who should report. After publication of the initial inventory, EPA will compile a revised inventory of chemical substances manufactured or processed for a com mercial purpose based on reports from processors of chemical substances, and from importers of chemical substances as a part of mixtures or articles. Para graph (b) of this section identifies who may report for this revised Inventory. Paragraph (c) of this section identifies FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64577 the persons not subject to the initial inventory. (a) The initial inventory--<1) Domes tic manufacturers who must report con cerning chemical substances. Any per son who manufactured a chemical sub stance's) in the United States for a commercial purpose during calendar year 1977 must report concerning: i > All chemical substances which that person manufactured in the United States during calendar year 1977 at each site for which: iA; Thirty percent or more of the weight of the products distributed from that site consists of products of the types described under Standard Industrial Classification (SIC) Group 28 or 2911, or (B) The total pounds of reportable chemical substances manufactured at that site equals one million pounds or more, and (ii) Any chemical substance not re ported under paragraph < a) * 1 > f i> of this section that was manufactured at a site during calendar year 1977 in quanti ties equal to or greater than 100,000 pounds. Note.--Any person who is a "small manu facturer." as defined in 5 710.2, and who has more than one site, is exempt from separately reporting the chemical substances manufac tured at each site. <2> Importers who must report con cerning chemical substances. Any per son who imported a chemical substance into the United States for a commercial purpose during calendar year 1077 must report concerning: i i) All chemical substances which that person imported into the United States during calendar year 1977 if: (A) Thirty percent or more of the weight of the products imported consists of products of the types described under Standard Industrial Classification iSIC) Group 28 or 2911, or i B i The total pounds of reportable chemical substances imported equals one million pounds or more; and (ii) Any chemical substance not re ported under paragraph (a) (2> ii) of this section that was imported during calendar year 1977 in quantities equal to or greater than 100.000 pounds. Note.--These reporting requirements in clude all chemical substances imported in bulX form, including in cans, bottles, drums, barrels, packages, tanks, bags and other con tainers. but do not include chemical sub stances imported as part of mixtures or articles. '3' Other manufacturers and import ers who should report chemical sub stances. 'ii Iij order to ensure that a chemical substance is included in the initial inventory, any person who manu factures or imports, or who has manu factured or imported a chemical sub stance 'including the importation of a chemical substance as part of a mixture or an article) for a commercial purpose since January 1, 1975, may report con cerning that chemical substance. 'ii) Any person permitted to report under paragraph (a)(3) of this section may either report individually or, in accordance with 5 710.5(f), authorize a trade association or other agent to report on his behalf. <b> Revised inventory. <l) During the reporting period for the revised in ventory (710.6(0), a person may re port concerning a chemical substance which was not included in the initial inventory If: (1) The person has processed or used the chemical substance (including use in the manufacture of a mixture or article containing that chemical substance) for a commercial purpose since January 1, 1975; or (ii) The person has imported the chemical substance as part of a mixture or article for a commercial purpose since January 1, 1975. (2) Any person permitted to report un der paragraph <b>.of this section either may report individually or, in accordance with 5 710.5(f), may authorize a trade association or other agent to report on his behalf. Note.--The premanufacture notification requirements of section 5(a)(1)(A) of the Act for manufacturers of new chemical sub stances and importers of new chemical sub stances in bulk wiU begin 30 days after the publication of the Initial Inventory and will apply to all chemical substances not included in the initial inventory. The premanufacture notification requirements of section 5(a)(1) lA) will not be applied to importers of chemical substances as part of a mixture until 30 days after publication of the re vised inventory. In addition, section 16(2) of the Act as it relates to section 5(a) 11) (A) will not be applied to persons who process or use for a commercial purpose chemical substances not on the Inventory until after publication of the revised inventory. <c> Persons not subject to the initial inventory. Persons who have only pro cessed or used a chemical substance for a commercial purpose are not subject to the Initial inventory requirements. 7iO.4 Scope of the inventory. (a) Chemical substances subject to these regulations. Only chemical sub stances which are manufactured, im ported, or processed "for a commercial purpose." as defined in 710.2, are sub ject to these regulations. <b> Naturally occurring chemical sub stances automatically included. Any chemical substance which is naturally oc curring and (li which is (i> unprocessed or f ii i processed only by manual, me chanical, or gravitational means; by dis solution in water; by flotation; or by heating solely to remove water; or ' 21 which is extracted from air by any means, shall automatically be included in the inventory under the category "Naturally Occurring Chemical Sub stances." Examples of such substances are: raw agricultural commodities; wa ter, air, natural gas, and crude oil; and rocks, ores, and minerals. id Substances excluded by definition or section 8 <b> of TSCA. The following substances are excluded from the inven tory: id Any substance which is not con sidered a "chemical suDstance" as pro vided in subsection 3(2) (B) of the Act and in the definition of "chemical sub stance" in 710.2(h) ; (2) Any mixture as defined in 710.2 <q>: Note.--A chemical substance that is manu factured as part of a mixture is subject to these reporting regulations. This exclusion applies only to the mixture and not to the chemical substances of which the mixture is comprised. The term "mixture" includes al loys. inorganic glasses, ceramics, frits, and cements, including Portland cement. '3) Any chemical substance which is manufactured, imported, or processed solely in small quantities lor research and development, as defined in 710.2 'yi; and (4) Any chemical substance not manu factured, processed or imported for a commercial purpose since January 1, 1975. (d) Chemical substances excluded from the inventory. The following chem ical substances are excluded from the in ventory. Although they are considered to be manufactured or processed for a commercial purpose for the purpose of section 8 of the Act, they are not manu factured or processed for distribution in commerce as chemical substances per se and have no commercial purpose sepa rate from the substance, mixture, or ar ticle of which they may be a part. Note.--In addition, chemical substances excluded here will not be subject to pre manufacture notification under section 5 of the Act. 'll Any impurity. (2 > Any byproduct which has no com mercial purpose. Note.--A byproduct which has commercial value only to municipal or private organiza tions who i i) burn it as a fuel. 111) dispose of it as a waste, including in a landfill] or for enriching soil, or (iii) extract component chemical substances which have commercial value, may be reported for the Inventory, but will not be subject to premanufacturing no tification under section 5 of the Act if not included. (3) Any chemical substance which re sults from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, mois ture, microbial organisms, or sunlight. (4) Any chemical substance which results from a chemical reaction that occurs incidental to storage of another chemical substance, mixture, or article. (5) Any chemical substance which re sults from a chemical reaction that oc curs upon end use of other chemical substances, mxtures, or articles such as adhesives, paints, miscellaneous cleans ers or other housekeeping products, fuels and fuel additives, water softening and treatment agents, photographic, films, batteries, matches, and safety flares, and which is not itself manu factured for distribution in commerce or for use as an intermediate. (6) Any chemical substance which re sults from a chemical reaction that oc curs upon use of curable plastic or rub ber molding compounds, inks, drying oils, metal finishing compounds, ad hesives, or paints; or other chemical FEDERAL REGISTER, VOt. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 64578 RULES AND REGULATIONS substances formed during manufacture of an article destined for the market place without further chemical change of the chemical substance except for those chemical changes that may occur as described elsewhere in this 710.4(d). (7) Any chemical substance which re sults from a chemical reaction that oc curs when (i> a stabilizer, colorant, odorant, antioxidant, filler, solvent, car rier. surfactant, plasticizer, corrosion inhibitor, antifoamer or de-foamer, dis persant, precipitation inhibitor, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality controf reagent functions as in tended or (ii> a chemical substance, sole ly intended to impart a specific physico chemical characteristic, functions as in tended. (9) Chemical substances which are not intentionally removed from the equip ment in which they were manufactured. Note.--See note to definition of "inter mediate" at 5 710 2' n) for explanation of "equipment in which it was manufactured." 710.5 How to report. (a) General instructions. (1) Except for small manufacturers or small import ers. any person who is required to re port under I 710.3(a) (1) or (2) shall follow the reporting procedures of para graphs (b), (c), and (d) of this sec tion. (2) Any person who reports under 710.3(a) (3) shall follow the reporting procedures of paragraphs (bJ, (c), (d) (1) and (d) (3) of this section. In addi tion, the Agency encourages these per sons to report in accordance with para graphs (d) (2) and (d) (4) of this sec tion. A trade association or other agent may report aggregated production data under paragraph (d) (4) of this section. (3) Any person who is required to report under 710.3(a) (1) or (2) and who is a small manufacturer or small importer as defined in 710.2 shall fol low the reporting procedures of para graphs (b), (c). and (d) (1) and (3) of this section except that such person is exempt from reporting production volume (for quantities less than 100,000 pounds' and site information. (4) Any person who reports under sec tion 710.3(b) shall follow the reporting procedures of paragraphs (b), (c), and id'ili of this section. (b) Reporting the identity of a chemical susbtance. (1) Any person re porting under these regulations should first read and carefully follow the re porting instructions, "Reporting for the Chemical Substance Inventory," pub lished by and available through EPA. 12) To report a chemical substance, a person should first consult the TSCA Candidate List of Chemical Substances and any amendment to the Candidate List. For assistance in using the Candi date List, consult the "Guide to the Use of the TSCA Candidate List of Chemical Substances." (3) All persons required to report ex cept "small manufacturers and im porters" must use a separate Form A, B, or C to report chemical substances for each site. Small manufacturers and im porters may report several chemical sub stances manufactured at different sites on one form, as appropriate. (4) To report a chemical substance found in the Candidate List, or in an amendment to the list, a person must complete, sign, and submit EPA inven tory report Form A (EPA Form No. 77103A). All forms, A through D, have OMB No. 1585 77011. (5) To report a chemical substance not found in the Candidate List, or in an amendment to the list, but for which there is a Chemical Abstracts Service (CAS) Registry Number, a person must complete, sign and submit EPA inventory report Form B (EPA Form No. 7710-3B). (6) To report a' chemical substance which is not found in the Candidate List, or in an amendment to the list, and for which there is no known CAS Registry Number, a person must complete, sign, and submit EPA inventory report Form C (EPA Form No. 7710-30. Persons must describe chemical substances on Form C as specifically as possible, in ac cordance with the instructions published by EPA, "Reporting for the Chemical Substance Inventory." (7) To report a chemical substance whose chemical identity is claimed to be confidential, a person must complete, sign, and submit EPA inventory report Form C (EPA Form No. 7710-30. In addition, he must substantiate the claim that the chemical identity is confidential at the time he submits the form to EPA, in accordance with instructions pub lished in "Reporting for the TSCA In ventory" and section 710.7. Note.--The reporting Instructions also de scribe a reporting Form D (EPA Form No. 7710-3D). This is for additional voluntary reports which may be submitted by any per son who manufactures trademarked products comprised of chemical substances and is not a substitute for any of the reports required by these regulations. (c) Reporting polymers. (1) To report a polymer a person must list in the de scription of the polymer composition at least those monomers used at greater than two percent (by weight) in the manufacture of the polymer. (2) Those monomers used at two per cent (by weight) or less in the manufac ture of the polymer may be included as part of the description of the polymer composition. Note.--The "percent (by weight)" of a monomer is the weight of the monomer ex pressed as a percentage of the weight of the polymeric chemical substance manufactured. <d) Reporting other information con cerning a chemical substance. (1) For purposes of the initial inventory, desig nate whether the person manufactures and/or imports the chemical substance. For purposes of the revised inventory, designate whether the person processes and/or imports the chemical substance. (2) Report the site(s) at which the person manufactures and/or imports the chemical substance. The site, as defined in 710.2(w), for importers is their busi ness address. (3) Designate whether the person manufactures and processes the chemical substances only within a site and does not distribute the chemical substance, or any mixture or article containing that substance, for commercial purposes out side that site. Note.--This requirement does not apply to Importers. (4) Report the amount of-the chemical substance which the person manufac tured at each site and/or imported dur ing calendar year 1977. For each sub stance, report the digit (e.g,, 0 through 9) which corresponds to the appropriate volume range, according to the following table. Enter "N" in the space provided for production amounts if the person did not manufacture or import the sub stance during calendar year 1977. Small manufacturers or importers, as defined in 710.2(x), should enter "X" in the space provided for production amounts of less than 100,000 pounds (45,400 kilo grams) . If a small manufacturer or im porter reports these production amounts, that person shall enter both "X" and the appropriate digits (e.g., X0. XI, or X2). For other production ranges, do not in clude an "X" (e.g., 3 through 9). Trade associations or other agents should en ter "A" in the space provided for pro duction amounts. If trade associations or agents report production volumes, they should enter both "A" and the ap propriate digits (e.g., A2 or A6). (0) Less than 1,000 pounds; Less than 454 kilograms. . (1) 1,000 to 10,000 pounds; 454 to 4.540 kilograms. (2) 10,000 to 100,000 pounds; 4,540 to 45,400 kilograms. (3) 100.000 to 1 million pounds; 45,400 to 454,000 kilograms. (4) 1 million to 10 million pounds; 454,000 to 4.54 million kilograms. (5) 10 million to 50 million pounds; 4.54 million to 22.7 million kilograms. (6) 50 million to 100 million pounds; 22.7 million to 45.4 million kilograms. (7) 100 million to 500 million pounds; 45.4 million to 227 million kilograms. (8) 500 million to 1 billion pounds; 227 million to 454 million kilograms. (9) over 1 billion pounds; over 454 million kilograms. (A) Trade associations or other agents. (e) Importers. (1) Any Importer who reports a chemical substance for the in ventory may authorize the foreign sup plier of the imported chemical sub stance (s) to report to EPA on his behalf, if both the foreign supplier and the im porter sign the declarations provided on the reporting forms. A foreign supplier may authorize an agent to act in his behalf. (2) The importer has the ultimate re sponsibility for reporting all information required by this Part and for the com pleteness and truthfulness of such infor mation. If certain information is not or cannot be provided by the foreign sup plier or his duly authorized agent, it must be provided by the importer. FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64579 (f) Trade associations or other agents. EPA without further notice to the sub chemical name proposed by the submit < 1) A trade association or other agent mitter. Failure to provide substantiation ter claiming confidentiality. may report on behalf of any person who of any claim asserted on the forms will (1) If EPA determines that the generic is not required to report for the initial be considered a waiver of the claim and name proposed by the submitter assert inventory under 5 710.3 (a)(1) and (a) will result in a determination that the ing the claim Is only as generic as neces (2). Accordingly, a trade association or information is not entitled to confiden sary to protect the confidential identity other agent may report on behalf of a tial treatment. of the particular chemical substance, manufacturer or importer of a chemi <e) (1) A claim of confidentiality may EPA will place that generic name on the cal substance who chooses to report un be asserted concerning the specific chemi inventory. der S 710.3<a> <3>. or any processor or cal identity of a particular chemical sub (ii) If EPA determines that the user of a chemical substance, or any im stance. This claim may be asserted by generic name proposed by the submitter porter of a chemical substance as part any submitter who believes that inclu asserting the claim is more generic than of a mixture or an article who chooses sion of the specific chemical identity on necessary to protect the confidential tc report under 5 710.3 (b>. the inventory would reveal the trade identity, EPA will ask the submitter to <21 For every chemical substance re secret fact that the particular chemical submit further proposed generic names. ported by a trade association or other substance is manufactured or processed (iii) If EPA does not agree with the agent under this section, at least one for commercial purposes. further proposed generic names, EPA manufacturer, importer or processor <2) If a submitter asserts such a claim will choose a generic name that EPA must have certified to that agent, and be the submitter must determines is only as generic as neces able to document to EPA, in accordance (i) Report the specific chemical iden sary to protect the confidential identity. with 710.HC', that the chemical sub tity, EPA will give 30 days notice of this stance was manufactured, imported, or i ii) Propose a generic chemical name choice to the submitter asserting the processed for a commercial purpose since which is only as generic as necessary to claim. After the end of the 30-day January 1, 1975. protect the confidential identity of the period EPA will place the chosen generic 710.6 When lo report. particular chemical substance, name on the inventory. (iii) Provide a detailed, written sub (g)(1) If the particular chemical sub <a) All reports for the initial inven stantiation of the claim as specified in stance a person is proposing to manu tory shall be submitted by May 1, 1978. the reporting instructions, facture is not included on the inventory (b> All reports concerning chemical substances which are manufactured or imported for a commercial purpose for the first time during the period from May 1, 1978 to the effective date of pre manufacture notification requirements shall be submitted when such manufac turing or importation begins. <c> All reports for the revised inven tory shall be submitted within 210 days after publication of the initial inven tory. 710.7 Confidentiality. ia) A manufacturer, importer, or processor may claim that for a particu lar chemical substance any or all of the following items of information submit ted under this Part are entitled to confi dential treatment: 11) Company name. (2) Site. 13) The specific chemical identity. (4) Whether the chemical substance is manufactured, imported, or processed. 5) Whether the chemical substance is manufactured and processed only within one site and not distributed for commercial purposes outside that site. i6) The quantity manufactured, im ported, or processed. ib> 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 infor mation is submitted to EPA and in the manner prescribed on the form. In ad dition. any claims of confidentiality must be substantiated at the time the information is submitted to EPA in the manner specified in the form instruc (iv) Agree that EPA may disclose to a person with a bona fide intent to manu facture the substance (as defined in paragraph (g) of this section) the fact that the particular chemical substance is included in the inventory for purposes of TSCA section 5(a)(1)(A) premanu facture notification, and (v) Have available, and agree to fur nish to EPA upon request, for the par ticular chemical substance, either an X-ray diffraction pattern (in the case of inorganic substances) or a mass spec trum for the particular chemical sub stance (in the case of most other sub stances). a sample of the substance in its purest form, an elemental analysis, any additional or alternative spectra, or other data that may be required to re solve uncertainties with respect to the identity of the substance. Failure to meet any of these five requirements will be considered a waiver of the claim and will result in inclusion of the particular chemical identity on the inventory. <f) (1) If a submitter asserts that the identity of a particular chemical sub stance should not be included on the inventory, the submitter has met the five requirements specified in paragraph (e) of this section, and the EPA General Counsel has made a determination, in accordance with Part 2 of this Title that the particular chemical identity should not appear on the inventory because in clusion would disclose a trade secret. EPA will publish a generic chemical name in an appendix to the inventory rather than place the specific chemical identity on the inventory. Publication by specific name but does fall within one of the generic chemical names in the appendix entitled "Confidential Id entities," the person may ask EPA wheth er the specific substance is included on the inventory. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manu facture the substance. (2) In order to establish a bona fide intent to manufacture the specific chem ical substance the person proposing to manufacture the chemical substance must submit to EPA: (i) A signed statement that that per son intends to manufacture the sub stance for commercial purposes, (ii) A description of the research and development activities he has conducted to date and the purposes for which the substance will be manufactured, (iii) An elemental analysis, (iv) Either an X-ray diffraction pat tern (in the case of inorganic sub stances) or a mass spectrum (in the case of most other substances) of the particu lar chemical substance, (v) A sample of the substance in its purest form, if requested, and (vl) Any additional or alternative spectra, or other data that may be re quired to resolve uncertainities with re spect to the identity of the chemical sub stance. (3) (i) Upon receipt of the informa tion specified in paragraph (g) (2) of this section, EPA may require the submitter who asserted the confidentiality claim for a specific chemical substance within the generic name to submit to EPA: tions. of a generic name in the appendix does (A) Either an X-ray diffraction pat ici Any information that is covered by not create a category for purposes of the tern or a mass or alternative spectrum a claim made as specified will be dis inventory. Any person proposing to man for the substance, closed by EPA only to the extent per mitted by, and by means of, the proce dures set forth in this section and in Part 2 of this Title (41 FR 36902). id) If no claim accompanies informa ufacture a substance included in the ap pendix under a generic name must sub mit notice under section 5(a) (1) (A) of the Act unless specifically exempted by (B) An elemental analysis of the sub stance, (C> A sample of the substance in its purest form, if requested, and tion at the time it is submitted to EPA, EPA (see paragraph (g) of this section). (D/ Any additional spectral or other the information may be made public by 12i EPA will examine the generic data that may be required to resolve un FEDERAl REGISTER, VOL. 42. NO. 247--FRIDAY, DECEMBER 23, 1977 64580 RULES AND REGULATIONS certainties with respect to the identity of the substance. (ii) Failure to submit any of the in formation required by EPA under this pargraph (g)(3) will be construed as a waiver of the submitter's confidentiality claim, and EPA will place the specific chemical identity on the inventory with out further notice to the submitter. 14 > EPA will compare the information submitted by the proposed manufacturer under paragraph (g)(2) of this section with the information submitted under paragraph (g)(3) of this section. (5) If (i) the comparison of the ele mental analyses and either the X-ray diffraction patterns or mass or alterna tive spectra is sufficiently similar to be consistent with a presumption that the chemical substances are the same, and (ii) comparison of any of the other sub mitted information affirms this pre sumption, EPA will tell the person pro posing to manufacture the particular chemical substance that the particular chemical substance is included on the inventory and, therefore, that premanu facture notification is not required. (6) If (1) the comparison of either the X-ray diffraction patterns or the mass or alternative spectra is not sufficiently similar to be consistent with a presump tion that the chemical substances are the same, and (ii) comparison of the other information affirms this conclusion, EPA will tell the person proposing to manu facture the particular substance that the information submitted does not support a conclusion that the substance is in cluded on the inventory, and, therefore, that premanufacture notification is re quired. (7) A disclosure to a person with a bona fide intent to manufacture a par ticular chemical substance will not be considered a public disclosure. 710.8 Effective dale. These regulations shall take effect on January 1, 1978. Appendix A--Significant Comments and Responses Over 400 comments were received in re sponse to the notices of proposed rulemaking published In the Federal Register on March 9. August 2. and October 3. 1977. The follow ing summarizes and responds to the sig nificant Issues raised In these comments. Comments which concern problems specific to one particular company were not generally Included In these comments. These com ments were referred to EPA's Industry As sistance Office for direct reply. Contents Overall Approach to these Reporting Rules. Comments 1-12. Which Persons are Subject to these Regula tions. Manufacturers, comments 13-17; Im porters. comments 18-23: Definition of Small Manufacturer or Importer, comments 24-27; Processors, comment 28. Chemical Substances Manufactured or Processed For a Commercial Purpose. Com ments 29-30. Eiclusions to the Definition of Chemical Substances. Mixtures, comments 31-36; Pes ticides and Poods, Food Additives, Drugs, Cosmetics and Devices, comments 37-42. Chemical Substances Excluded from the Inventory. Small Quantities for Research and Development, comments 43-51; Byproducts, comments 52-55; Articles, comments 56-60; Impurities, comment 61. Chemical Substances Included in the In ventory. Comments 62-63; Test Marketing, comments 64-66; Intermediates, comments 67-71; Naturally Occurring Substances, com ments 72-74. Inventory Reporting Procedures. Oeneral, comment 76; Reporting of Polymers, com ments 77-82; Inventory Reporting Forms, comments 83-87. When To Report. Comments 88-92. Confidentiality. Comments 93-103. OVERALL APPROACH TO THESE REPORTING RULES Comment 1: Reporting under these first reporting rules should not only be for the purpose of compUlng the inventory required by section 8(b), but also to establish a base line of information for further regulatory action under TSCA. Failure to gather site, production, use, impurity, byproduct, dis posal, and worker exposure information in a comprehensive manner precludes a system atic approach to the regulation of chemicals. Response: The Administrator agrees, in part, with this comment. The August 2, 1977, reproposal expanded the purpose of these regulations as proposed on March 9, 1977. These final regulations are similar to those proposed on August 2nd. In deciding the scope of these first sec tion 8(a) reporting requirements, EPA con sidered not only the interest of compiling an inventory of chemical substances, as re quired by TSCA section 8(b), but also the need for obtaining sufilctent information for monitoring chemical substances in the environment and setting Agency priorities for implementing other provisions of TSCA. The Agency decided that initial reporting requirements should at least establish a profile of the chemical industry. Including sites where chemicals are being manufac tured and the relative quantities in which they are produced or imported into the United States. With this information, EPA will be able to estimate the potential expo sure to chemical substances for control, and preventive actions. For example, plant site information will be useful in identifying possible sources of hazardous chemicals, es pecially in an emergency. Data on the quan tities of chemical substances manufactured for a commercial purpose will enable EPA and other agencies to select substances for priority attention from among the tens of thousands of chemicals in commerce. The Agency will not be requiring use, im purity, byproduct, disposal, or worker ex posure Information in these regulations. The Administrator has determined that this in formation is not now necessary for all chem ical substances manufactured for a commer cial purpose, and that the additional burden to Industry and consequent delay in publi cation of the Inventory would not be justi fied. EPA Intends, under the authority of section 8(a), to require this additional in formation on a smaller number of chemicals in order to assess their potential risks In depth. These requirements will be directed at manufacturers and processors of the chemical substances to enable the Agency to build a more complete profile on these chemicals which are of concern. Comment 2: EPA's proposed approach would require unnecessarily burdensome and needlessly duplicative reporting. EPA should compile and publish a list of chemi cal substances from government, industry, and other sources, anck allow'manufacturers and trade associations to report any chemi cal substances not included. Response: The Administrator disagrees with this comment. The Agency reviewed existing lists of chemical substances and found them inadequate in several respects. First, many existing lists contain chemical substances which are not eligible for inclu sion on the TSCA Inventory. Second, in existing lists, many of the entries are in broad categories or use groups (such as "op tical brlghteners") which would be inappro priate for the purposes of compiling a list of discrete chemical substances manufac tured or processed for a commercial purpose In the United States. Third, existing lists would not permit EPA to identify the basic manufacturers of a chemical substance. The purposes of TSCA, accordingly, would not be met if EPA were simply to publish currently available lists as the inventory of chemical substances and permit manufacturers to re port any substance not included. EPA is Interested in minimizing the burden of reporting for the inventory. Accordingly, the Agency has published a Candidate List of Chemical Substances which includes those substances we have reason to believe have been manufactured or processed in the United States. For any chemical substance included on the Candidate List-reporting for the inventory is greatly simplified. By Fed eral Register notice dated April 28. 1977 (42 FR 21639) and July 8, 1977 (42 FR 35183), the Agency announced the avail ability of the Candidate List in hard copy and computer readable tape. EPA plans to supplement the Candidate List with at least one additional list of substances. EPA will announce the availability of any additional list in the Federal Register. By Federal Register notice dated April 12, 1977 (42 FR 19298) the Agency published a proposed Guide to the Use of the Candidate List. This Guide will be republished with some changes to assist persons reporting for the inven tory. This document and any supplement to the Candidate List will be available from EPA at the address listed above. In a further effort to minimize duplica tive reporting to the extent consistent with the needs of the Agency, ! 710.5(f) of these final regulations permits all manufacturers or Importers not required to report by S 710.3 (a) (1) and (2) to report chemical sub stances through a trade association or other agent. Further, any person who processes a chemical substance is only subject to the revised Inventory. These policies should elim inate a great amount of duplicative report ing. Comment 3: Manufacturers Bhould be re quired to report chemical substances manu factured for a commerical purpose by plant site rather than by company headquarters. Response: The Administrator agrees with this comment. The March 9, 1977 proposal would only have required manufacturers to report chemical substances by company headl(uarters. As part of the decision to re quire reporting of information which will give the Administrator a profile of where chemicals are being manufactured, the August 2, 1977 reproposal would require re porting by plant site. These final regula tions continue this requirement. The Agency Intends to use this information to monitor for potential exposure and Identify possible sources of hazardous chemicals in an emer gency. Comment 4: EPA has failed to demon strate that production volume data are necessary to compile the inventory, and it is unclear how EPA Intends to use this addi tional information. In emergencies, EPA needs to know where a chemical la produced, not the exact quantity. The delay in pub lishing the Inventory is not Justified' by the information to be gained by requiring more detailed data. Response: Production volume Information is not being required to publish the inven tory under section 8(b). This information is FEDERAL REGISTER, VOL. 42, NO. 247--FRIOAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64581 required under the general authority of section 8<a) of the Act, to require sub mission of information necessary for ad ministration of TSCA. EPA intends to use the production volume data to help set priorities for implementing TSCA. In particular. EPA will initiate sub sequent phases for reporting on chemical substances selected In part on the basis of their production volume. Section 710.5(d) (4) requires reporting of production in fairly broad ranges. (See comment 6.) Because manufacturers should know generally how much of a chemical substance they manu facture on an annual basis. EPA does not anticipate that this requirement will sig nificantly delay reporting. Combining report ing of production with reporting of chemical substance identities is far more efficient, in terms of time and resources both for EPA and the industry, than requiring separate reporting. Saving many months of additional effort clearly justifies the few months of delay in the publication of the initial in ventory. Comment 5; Production volume data are available elsewhere, notably from trade as sociations and other governmental agencies. EPA also has authority under Air and Water Acts to gather the data. Response: The production data available to EPA from other sources are Inadequate to several respects. Other government agen cies, such as the International Trade Com mission, believe they are not permitted, by statute, to disclose confidential production datar to EPA. Further, these data are often collected for groups of chemical substances, and not for discrete chemical substances. While EPA has gathered certain data for several hundred chemical substances under Its other authorities, these substances repre sent only a fraction of those EPA anticipates will be reported for the inventory. Only by collecting production information along with the chemical Identities as they are reported for the inventory will EPA be as sured of having a comprehensive indication of production for these substances. Comment 6: Several commenters suggested that production volume data should be re ported in broad ranges because statistical analysis shows that aggregate totals will pro vide enough accuracy for EPA to set relative priorities. Others recommended that produc tion volume data should be reported to one or two significant figures or to within a specified percentage. Response: As provided In $ 710.6(d) (4), the Administrator has determined that reporting of production volume in ranges Is adequate for the purposes of these regulations. The ranges established by these regulations are in terms of powers of ten, except in the upper volumes where the difference between the lower and upper limits of the ranges would be too great. In subsequent section 8(a) re porting requirements, when the Agency has identified a particular interest in a chemical, the Administrator may request production volume information with greater specificity. Comment 7: Total production volume in formation for a company should be required, rather than site specific information. Response: The Administrator disagrees with this comment.`In order to establish an adequate profile of the chemical Industry and properly assign agency resources, par ticularly the agency's regional resources, pro duction information is necessary on a site specific basis. Comment 8: Production volume informa tion on intermediates, raw materials, and byproducts should not be required. Response: Section 710.5(d)(4) of these regulations will require reporting of produc tion volume information on intermediates. As discussed in response to comment 67 be low, the term "intermediate" has been de fined to Include only those chemical sub stances that are intentionally removed from the equipment in which they are manu factured. The Agency expects that a manu facturer will be able to estimate the range of production volume of the intermediates which he isolates In this manner. Under these regulations, manufacturers are not required to report the identity of pur chased raw materials or byproducts which have no commercial value. Accordingly, a manufacturer would not be required to re port the production volume of these sub stances. Comment 9: EPA should not set its priori ties on the basis of production volume alone. Response: EPA recognizes that priorities under TSCA cannot be set on the basis of any single factor. The production data ob tained under these regulations will be only one factor in selecting chemical substances for attention. Production volume informa tion is Important because it gives some indi cation of the potential for human and envi ronmental exposure. Other information such as the toxicity of the substance. Its uses, and byproducts will, as appropriate, also be considered in assigning relative priorities to substances for testing and other regulatory actions. Comment 10: EPA should not require a designation of those chemical substances that are site-limited. This information may be confidential and any use of sucb a sub stance for commercial purposes outside the manufacturing site is not necessarily a "sig nificant new use" for the purpose of TSCA section 5(a) (1) (B). RESPONSE: Section 710.5(d)(3) will re quire designation of those chemical sub stances which are manufactured and pro cessed within a site and are not distributed for a commercial purpose outside the site. The information will be used by EPA and other agencies to identify those chemical substances which may have little exposure to the general environment. Section 710.7 of these regulations recog nizes that the fact that a particular chemical substance is "site limited" may be claimed as confidential. If a claim of confidentiality is asserted it will be bandied in accordance with the Agency's business confidentiality regulations, 40 CFR Part 2. EPA has not decided exactly how it will propose to define "significant new use" for the purposes of notification under section 5(a)(1)(B). The comments which we have received are quite extensive on this point and correctly emphasize the various considera tions set forth In section 6(a)(2). EPA in tends to take Into account all these con siderations prior to issuing a proposed rule under section 5(a)(2). Comment 11: Compilation of production volume and site data will be a time-consum ing and expensive procedure since many companies will have to consult production batch sheets and inventories. This burden is greatly increased by requiring the reporting of isolatable intermediates. Response: In preparing the final regula tions, EPA has attempted to reduce the bur den of reporting to industry while obtaining Important Information. As discussed in re sponse to comment 6, these regulations would require reporting In fairly broad ranges of the production of chemical substances. Fur ther. as discussed In response to comment 67. EPA has revised Its definition of "inter mediate" to exclude "Isolatable intermedi ates", or those which "could be isolated," but are not. These amendments should greatly reduce the potential reporting bur den to industry. Moreover, the burdens of compiling the production and site Informa tion required by these regulations has been considered In establishing the definition of "small manufacturer" under these regula tions. As discussed in greater detail in re sponse to .comment 94. small manufacturers are not required to submit this information. Comment 12: Certain industries may find it more convenient to report their chemicals in units other than pounds. Cubic feet for gas, and barrels for petroleum products are two examples. Further, manufacturers should be able to report in metric units. Response: In order to simplify reporting and to enable EPA to process the information In a timely fashion, it is very important that manufacturers report production volumes according to the ranges established by 5 710.5(d)(4). EPA expects manufacturers who normally deal in other units of measurement to be able to convert to the specified ranges. The table of ranges is provided In both pounds and kilograms to facilitate reporting by persons using the metric system. In In stances where manufacturers cannot deter mine the actual weight of a chemical sub stance, a best estimate should be made. WHICH PERSONS ARE SUBJECT TO THESE REGULATIONS Manufacturers Comment 13: EPA will lose valuable infor mation by not requiring all chemical manu facturers to report for the inventory. There are many ohemlcal manufacturers outside of SIC groups 28 and 2911 and EPA will not be able to locate these potential sources of hazardous chemicals. The Agency does not have the discretion to exempt some chem ical manufacturers from the reporting obli gation. Response: The Administrator interprets section 6(a) of the statute as giving EPA broad discretion to determine the manufac turers who shall be subject to any reporting rule. By directing these reporting requirements to manufacturers substantially engaged in producing chemical products of the types described under SIC 28 or 2911 the Agency is focusing on that segment of the Industry which is of primary concern under TSCA. By narrowing the population of manufacturers required to respond from a possible 225,000 establishments who may be engaged in proc essing chemical substances to approximately 8,400 establishments engaged in manufac turing chemical substances, EPA will dra matically reduce potential duplication of re porting and still create a data base which is comprehensive with respect* to principal chemical manufacturers. EPA expects the initial Inventory to contain over 96% of the chemical substances manufactured and proc essed for a commercial purpose in the United States. In response to this comment, however. In order to increase the reliability of the data base which the Agency will generate, EPA has expanded the category of manufacturers who must report, in two respects. First, 710.3(a) (1) (i) (B) requires manufacturers who have produced one million or more pounds of a reportable chemical substance(s) at a plant site to report concerning all chem ical substances manufactured at that site during 1977. This criterion applies whether or not the manufacturing establishment would be Included in SIC Code 28 or 2911. Second 9 710.3(a) (1) (li) requires all manu facturers to report concerning any chemical substance that they manufactured at one plant site in quantities equal to or greater than 100,000 pounds during calendar year 1977. The Agency, accordingly, will receive re porting on all the chemical substances manu factured at plants included in the chemical and allied products sector of the industry and at the plants of the largest manufacturers in the other sectors. In addition, the data base will include at least all chemical sub FEDERAL REGISTER, VOL. 41, NO. 247--FRIDAY, DECEMBER 13, 1977 64582 RULES AND REGULATIONS stances produced in quantities equal to or greater than 100.000 pounds annually at any plant site. Comment 14: Since any manufacturer whose chemical substance Is not Included in the Initial Inventory will be required to comply with the premanufacture notification requirements of section 5(a)(1)(A), manu facturers outside SIC groups 28 and 2911 will still be forced to report their chemicals to ensure that they are included on the inven tory. Thus EPA's efforts to reduce duplica tive reporting will not be successful. Response: The Administrator believes that these regulations will reduce duplicative re porting. Those manufacturers who are not required by 5 710.3(a) (1) or (2) to report chemical substances have several options for ensuring the chemical substances they man ufacture are Included on the inventory. First, they can report Individually. Second, these manufacturers can rely* on their knowledge that another manufacturer is reporting the chemical substance. Or, third, as provided In 710.5(f). they can ensure that the chemical substances are reported by a trade association or other group. Thus, the inventory reporting burden on these persons will be minimized and the number of reports submitted to the Agency will be greatly reduced. Comment IS: EPA should clarify by notice in the Federal Register or by direct mailing, exactly who is Included In SIC groups 28 and 2911. Response: The Agency Intends by direct mail to notify those persons included on the Dun and Bradstreet list of JSIC Code 28 or 2911 manufacturers, as well as others who are Included on EPA's mailing list, concerning these reporting regulations. Moreover, EPA has decided for administrative and legal rea sons not to rely on the designations of SIC groups that the Bureau of Census assigns to all manufacturers. Instead, 5 710.3(a)(1) of these regulations sets forth Independent cri teria for reporting for these regulations. Manufacturers should be able to determine for themselves whether the reporting require ments are applicable to them. The proposed criteria should encompass at least those man ufacturers In SIC groups 28 and 2911, as des ignated by the Bureau of Census. Any manu facturer meeting the criteria of S 710.3(a) (1) is subject to these regulations regardless of whether he has been assigned to SIC group 28 or 2911 by the Buerau of Census and whether he receives a letter from this Agency. Comment 16: Trade associations should let non-member firms add to any list of man ufactured chemicals. Response: In allowing trade associations to report, the reguatldns do not stipulate that the persons for whom the trade associations may report are actual members of that asso ciation. Section 710.5(f) of these regulations only requires that for every chemical sub stance reported by a trade association at least one manufacturer, importer, or processor must have certified to that trade association, and be able to document to EPA, that the chemical substance was manufactured. Im ported. or processed In accordance with these regulations. Comment 17: A company which contracts with another company to manufacture a chemical substance for a commercial purpose should be allowed to report that chemical substance for the Inventory. Response: The Administrator agrees with this comment. EPA recognizes that there are companies who contract with other com panies to manufacture chemical substances for commercial purposes. The company who actually manufactures the substance Is, of course, responsible for reporting any chemi cal substance manufactured during calendar year 1977, In accordance with 5 710.3(a)(1). In addition, the manufacturer may.report for the Inventory under S 710.3(a) (3) The com premanufacture notification of new chemi pany who has contracted for manufacture of cal substances Imported as parts of mixtures. the chemical substance may also report for Response: The Administrator agrees with the Initial Inventory. If he has reason to be this comment. On October 3, 1977, EPA pub lieve that the manufacturer has no Intention lished In the Federal Register a supplemen of reporting the substance. For example, the tal notice (42 FR 53804) addressing the manufacturer may no longer'be In business or applicability of these regulations and pre may not have manufactured the substance manufacture notification requirements to since January 1. 1977, and does not Intend importers of chemical substances as part of to continue manufacturing the chemical sub mixtures. Since an Importer of a mixture la stance. If the contractor reports for the In also importing the component chemical ventory he must be able to certify that the substance In the mixture, such an Importer chemical substance was manufactured since would be subject to the premanufacture no January 1, 1975, and provide the address of tification requirements with respect to all the manufacturing site. new chemical substances. Accordingly, al Importer though Importers of chemical substancea as part of mixtures are not required to report Comment IS: Importers and foreign sup for compilation of the Inventory, they should pliers should be permitted to appoint a mu ensure that the chemical substances they tually agreeable agent to report for the In Import are Included on the Inventory. A3 ventory. It la unfair to hold small Importers provided In 15 710.3(a)(3) and 710.3(b). liable for reporting the chemicals manufac they may report either during the reporting tured by a large International corporation. period for the Initial Inventory or the re Response: Section 710.5(e) of these regu porting period for the revised Inventory. lations provides that an importer required And, as provided In 5 710.5(f), they may re to report chemical substances may authorize port through a trade association or other a foreign manufacturer, or an agent of a agent. The premanufacture notification re foreign manufacturer, to report on the Im porter's behalf. Because the jurisdiction of TSCA reaches the importer and not the foreign manufacturer, EPA must hold the Importer liable. An Importer is free, however, to take whatever legal measures are neces sary In contracts with the foreign supplier to protect himself from penalties. Whatever conditions the Importer and reporting agent agree to, however, are outside the purview of these regulations. In addition, the reporting Instructions re ferred to In ! 710.5(b), "Reporting for the TSCA Inventory," will provide that Importers may report certain Information directly to EPA and request a foreign manufacturer or his agent to supply other Information. Thus, an Importer could arrange that he would send directly to EPA the trade name of the Imported chemical substance and the amount Imported, and that a foreign manufacturer or bis agent would submit the specific chem ical Identity of the trade name substance. The Agency expects such arrangements to be useful In the event some Information Is a confidential trade secret. Comment 19: Standard Industrial Classi fication (SIC) codes should be used to deter mine which Importers are required to re port. EPA should Insure that Importers are not required to report under S 710.3(a)(1) and should clarify the "site" for Importers for the purposes of these regulations. Response: The Administrator agrees in part with this comment. EPA has revised the final regulations to require reporting by Importers concerning all chemical substances Imported If (1) thirty percent or more of the weight of the products imported con sists of products of the types described under SIC 38 or 2911, or (2) the total pounds of reportable chemical substances Imported equals one million or more pounds. In addi tion. Importers must report any chemical substance Imported during calendar year 1977 In quantities equal to or greater than 100.000 pounds. These requirements parallel those under | 710.3(a) (1) lor domestic man ufacturers. An Importer, however, is not re quired to report under S 710.3(a) (1); he la required to report under 5 710.3(a)(2). As defined In 5 710.2 (w), the business address of an importer will be considered his site for the purposes -of these regula tions. Importers need not specify the port of entry for Importation of a chemical sub stance. quirements of section 5(a)(1)(A) will not be applied to Importers of chemical sub stances as part of mixtures until 30 days after publication of the revised Inventory. At that time, no person will be permitted to Import any mixture containing a "new chemical substance'' except In accordance with TSCA section 5. Please refer to the Oc tober 3, 1977 notice for a discussion of the legal and policy considerations supporting this decision. Comment 21: Importers of chemical sub stances as part of articles should not be re quired to report for the Inventory and should not be subject to premanufacture notification. Response: The Administrator agrees that Importers of chemical substances as part of articles should not be required to report for the Inventory, and Is reviewing whether any Importers of articles should be subject to premanufacture notification requirements. Sections 710.3(a)(3) and 710.3(b) provide, however, that Importers of a chemical sub stance as part of an article may report for the Initial and revised Inventory. The October 3, 1977 supplemental notice (42 FR 53804) In the Federal Register dis cussed the applicability of these regulations and preraanufacture notification require ments to Importers of chemical substances as part of articles. Persons who Import arti cles also "Import" the component chemical substances. Thus, as discussed In response to comment 20, the Importer could be sub ject to the premanufacture notification re quirements with respect to all new chemical substances comprising the article. However, for reasons discussed In greater detail In the October 3, 1977 notice, the Administrator does not presently Intend the premanufac ture notification requirements of section 5(a) (1) (A) to be applied to the importation of all articles that contain a new chemical substance. As discussed in response to com ment 22, EPA will carefully consider the economic and International ramifications of any premanufacture notification require ments that may be applied to chemical sub stances Imported as part of articles. In the Interim, EPA will not consider persons who Import chemical substances as part of arti cles or who process or use such articles to be In violation of section 5(a)(1)(A). If upon re-evaluatlon. the Administrator determines that these requirements should be applied to importers of chemical substances Import ed as parts of some or all articles, or to Im Comment 20: If EPA allows mixtures which porters of selected chemical substances lm- contain substances not on the Inventory to . ported as parts of articles, a proposed notice be imported, foreign competitors will have will be published for further public com an unfair advantage. EPA should require ment. Such change In policy would be final- FEDERAl REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64583 ized before publication of the inittal inven tory so that any affected parties may report during the reporting period for the revised inventory. - Chemical substances or mixtures which are Imported within articles, such as In drums, barrels, or other containers used for purposes of transportation or containment, are con sidered to be chemical substances imported in bulk and are subject to these reporting requirements. Chemical substances or mix tures will be considered to be imported as a part of an article, if the substance or mixture Is not Intended to be removed from that article and has no end use or commer cial purposes separate from the article of which it is a part. Importers may report these chemical substances but are not re quired to do so. For example, transformer fluids in transformers, lighter fluids in cigarette lighters, and crankcase oil in auto mobiles are not Intended to be removed from the articles of which they are a part and have no commercial purpose separate from these articles. Accordingly, these chemical substances need not be reported. These same chemical substances, however, if imported in drums, cans, or other containers, must be reported as required by these regulations. The Agency will exercise its authority to regulate the Import of chemical substances which are part of articles (as well as im ported in bulk and in mixtures) under sec tion 6 or other authorities of the Act. as necessary to protect against unreasonable risks of injury to health and the environ ment. This might, for example, include pro hibiting. limiting, or. in other ways, re stricting the import of such chemical sub stances. Comment 22: Importers of chemical sub stances as part of an article have an unfair competitive advantage over domestic manu facturers because they can introduce new chemical substances into domestic markets without complying with premanufacture no tification requirements. This policy should be changed so that substances which are manufactured domestically at a site solely to be included in an article would not be considered commercial substances per se. Thus they would not be reported for the In ventory and would not be subject to pre manufacture notification. Response: The Administrator disagrees with this comment. EPA recognizes that the reporting requirements are not identical for importers and domestic manufacturers of chemical substances as part of an article, but EPA has tried to equalize the burdens of complying with these regulations, as di rected by the Act. With respect to the require ments for premanufacture notification, EPA will assess the impact of those requirements over the next several months as they are developed. Under $ 710.4(d) of these regulations some chemical substances manufactured as part of an article which have no commercial pur pose separate from the article of which they are a part, are excluded from the inventory and premanufacture notification require ments. To exclude from the inventory other chemical substances manufactured for a commercial purpose which are subsequently Incorporated in an article would create an unacceptable loophole and not fulfil] the purposes of the TSCA inventory. The domes tic manufacturer of a chemical substance who also manufactures an article Is only required to report the chemical substance(s) he actually manufactures. EPA does not be lieve that this Is an unreasonable burden. If under subsequent regulations the Agency Im poses certain requirements on domestic man ufacturers of chemical substances which are incorporated as parts of articles, in general the Agency will impose the same requlre- ments on importers of those chemical sub stances. Comment 23: In developing premanufac ture requirements under section 5. EPA should take Into account foreign manufac turers whose application for a patent for a new chemical substance with a foreign government may be Jeopardized by premanu facture notification under TSCA. Response: If a foreign government will not award a patent for a chemical substance whose identity has been disclosed, even to another government under a provision such as the premanufacture notification require ments of TSCA, persons should take this Into account and apply for the patent prior to the importation of the chemical substance into the United States. Definition of Small Manufacturer or importer Comment 24: The definition of "small manufacturer or importer'* proposed by EPA is unduly restrictive and ought to be revised. Response: The Administrator agrees with this comment. The definition of the term "small manufacturer or importer" at 710.2 (x) has been revised to mean a "manufac turer or importer whose total annual sales is less than $5 million, based upon the manu facturer's or importer's latest complete fiscal year as of January 1, 1978. except that no manufacturer or importer is a 'small manu facturer or Importer* with respect to any chemical substance which such person manufactured or Imported in quantity greater than 100,000 pounds during calen dar year 1977." This definition is different in several re spects from the definition of "small manu facturer or importer" which was proposed on August 2. 1977. In the first place, EPA has deleted the criterion based on the number of plant sites. It had been proposed that a manufacturer would be a small manufacturer If he had only one plant site. The Adminis trator has determined that for the purposes of these regulations, such a criterion would have little meaning. The one plant site criterion had little relation to burden on the small manufacturer. It also provided very little benefit to EPA because very few manu facturers who meet the other criteria will have more than one plant site. In the second place, whereas the August proposal would have defined as a "small manufacturer or Importer" a person with total sales of less than 8100,000, these final regulations consider a "small manufacturer or importer" a person who, In part, has total annual sales of less than 85 million, based on the manufacturers' or Importers' latest fiscal year as of January 1. 1978. The Agency re ceived extensive comments that the 8100.000 figure was unreasonably low, and has agreed that it should be substantially Increased. And, in the third place, these regulations provide that no person Is a "small manufac turer or importer" with respect to any chemi cal substance produced in quantities greater than 100.000 pounds annually. The August proposal had provided that a person would be a small manufacturer if he had no more than 2.000 pounds annual production of a chemical substance. The Agency has estab lished this criterion for the definition of the term "small manufacturer or Importer" based on its need for Information on chemi cals produced in substantial quantities. It is Important to emphasize that In ac cordance with section 6(a) (3) of TSCA, small manufacturers and Importers are not exempt from reporting Information necessary for compilation of the inventory. Accordlnelv, under these regulations, small manu facturers and Importers who are required to report (S 710.3(a) (1) and (2)) must report at least (1) the identities of the. chemical substances, and (2) whether they manufac ture. process, or Import the substance. Re porting of the chemical Identities is neces sary to publish the list required under sec tion 8(b). In order to enforce these Inventory reporting regulations, manufacturers, and importers must indicate whether they do manufacture or Import the substance. Under these regulations "small manufac turers" are also required to report whether the chemical substance is manufactured and processed only within one site and not dis tributed outside that site. The Administrator has determined that this is very important for utility of the inventory and that the burden of reporting this additional Informa tion by manufacturers is negligible. Spe cifically, EPA may want to use this informa tion. i.e., which chemical substances are now "slte-llmlted", for purposes of requiring notification under section 5(a)(1)(B) prior to distribution of such substances outside the manufacturing site. Small manufacturers and Importers are exempt from reporting the production vol ume and site information that will be reaulred by these regulations. As Is discussed in response to comments 1 through 12. this Information Is being required pursuant to the general reporting authority of section 8(a) to obtain sufficient information to im plement the provisions of TSCA. In defining "small manufacturer or Importer" EPA has attempted to balance the burdens to manu facturers and Importers of submitting this Information against the value of that Infor mation to the Agency. The Administrator has determined that reouirlng production and site Information from all manufacturers and Importers other than "small manufacturers and importers" as defined in these regulations, will not pre sent an unreasonable burden. For those firms with approximately 85 million in sales, the costs of reporting will range from about 0,6 percent of annual profits (for reporting for the Inventory alone) to about 1.2 percent (for also reporting product volume and iden tity of substances manufactured by site). These figures assume a 6 percent profit rate. For example, a firm with $5 million in sales and $300,000 In profits (6 percent) would have to spend about 83.500 (1.2 percent of $300,000) to comply with these regulations. The above costs would decrease as the size of the firm Increases. The firms generally most Impacted are those with the largest number of chemicals to report. Those firms with less than $5 mil lion In sales must report production volume by site for chemicals manufactured in quan tities In excess of 100,000 pounds. The costs to these firms will fall between 0.6 and 1.2 percent of profits, or between the costs of reporting for the inventory alone and the costs of reporting all required information. In analyzing the costs of reporting, ERA examined the costs to those required to re port under section 710.3. The bulk of re spondents would fall in SIC group 28. Chemi cals and Allied Products, or SIC 2911. Pe troleum Refining. The remaining respondents are those who are not classified as SIC 28 or 2911 firms but who have at least one site from which thirty percent or more of prod ucts distributed are of the type described by SIC 28 or 2911. or who either manufacture a total of one million or more pounds of reportable chemical substances or manufac ture one or more chemical substance in quantities of 100.000 pounds or greater. The costs per chemical of reporting for these additional firms would be similar to the costs estimated for the SIC 28 and 2911 firms. However, the costs as a percentage of sales would be smaller because chemical sales are a relatively smaller portion of their total sales. FEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 64584 RULES AND REGULATIONS In estimating the number of firms re quired to report by these rules, EPA started with the firms classified as primarily pro ducers of SIC 28 and 2911 products. This number was then reduced to account for those firms within SIC 28 and 2911 who are not manufacturers (i.e., processors) and those whose primary products are not covered by TSCA (eg., SIC 283, Drugs and SIC 2879, Pesticides). Firms whose major products are not in SIC 28 or 2911 but which had signifi cant chemical manufacturing activities were also examined and included in the analysis. The total number of firms expected to be re quired to report is estimated to be approxi mately 5400. This definition of small manufacturer will exempt approximately 78 percent of the firms required to report from complete reporting of production and site Information. Though the number of firms defined as small is sig nificant. they account for less than 5 percent of the sales and 8 percent of employment. EPA has consulted with the Small Business Administration ISBA) in developing this definition of "small manufacturer or im porter." The SBA suggested that EPA define as a "small manufacturer or importer" a company with 100 employees or less. Such a definition would exempt a slightly larger percent of firms; it would be equivalent to exempting companies whose total annual sales are approximately 86.8 million. These final rules substantially reduce the burden of reporting by requiring reporting only for intermediates which are actually isolated (see comment 67) and by requiring reporting of production volumes In broad ranges (see comment 6). Based on these changes, EPA believes that the definition of "small manu facturer or Importer" in these regulations is adequate to prevent unreasonable burdens on chemical manufacturers. The SBA concurs. Further analysis of the costs associated with this definition of "small manufacturer" is contained in the report, "Analysis of Op tions for Definition of Small Business and Estimated Cost of the Initial Section 8(a) Reporting Requirements", prepared by Arthur D. Little. Inc. and included in the rulemaking record. Comment 25: Several commenters sug gested that EPA should define "small manu facturer or importer" in terms of production volume and total annual sales: other com menters suggested that the term should be defined in terms of manufacturing sites, number of employees, assets, or value of sales per chemical. Response: The Administrator considered the utility of each of these parameters and, as is discussed in response to comment 24, has decided to rely on total annual sales and production volume. . The total annual sales of a manufacturer or importer are generally known and. there fore. use of this criterion would require no additional calculations. In addition, the value of sales gives a good indication of the ability of the company to bear the reporting burden. Generally the larger the sales, the larger the staff employed by the firm, and the more resources the company will have available to report to the Agency. Production volume gives a good indication of the potential for human and environmen tal exposure. Accordingly, these regulations use this cdterlon In conjunction with the sales criterion. However, a manufacturer or importer with total annual sales of less than $5 million dollars only must report pro duction volumes for those chemical sub stances produced in quantities greater than 100.00C pounds. Information on chemicals produced in such quantities has greater value to the Agency. As discussed in response to comment 24. the Administrator had determined that a cri- terlon on number of manufacturing sites Processors would have little meaning for the purposes of this regulation. It has no relation to cost or burden on a company and the additional in formation gained by EPA by including this criterion would be minimal since very few firms that satisfy the other criteria of the definition would have more than one plant site. The number of employees of a manufactur er or Importer may be useful a parameter for determining the burdens of a reporting requirement. However. It is not as good a measure as sales of the ability to bear the burden of reporting. This Is particularly true since there are significant variations in dollar sales per employee in various segments of the chemical industry reflecting a substantial difference In the abilities of various firms to bear the burden of reporting. Over the en tire industry, annual sales per employee is about oj.oOO. varying from $45,000 in SIC 2816, Inorganic Pigments to over $225,000 in SIC 2911. Petroleum Refining. Criteria based on assets or value of sales per chemical are also not included in these regulations. The value of assets would pro vide an indication of the size of a firm. How ever, the components of total assets are com plex and the information Is not generally available to the public. Further, assets may not bear any relationship to a company's ability to absorb these reporting costs. Value of sales per chemical produced might provide a good measure of a company's ability to bear reporting costs; however, this criterion would require a company to make a deter mination as to whether It was a "small man Comment 28: EPA does not have the dis cretion to prevent processors of chemical substances (including manufacturers of a mixture or article containing the chemical substance) from reporting for the Initial inventory. Response: EPA Interprets section 8(a) of the statute as providing broad discretion to determine which persons shall be subject to any reporting rule. Section 710.3(c) pro vides that the processors are not subject to the initial inventory. They may report chemical substances not included on the initial inventory during the reporting period for the revised inventory. These regulations provide that persons who will be subject to the premanufacture notifi cation requirements of section 5(a)(1)(A) of the Act are subject to the initial inven tory. The requirements of section 5(a)(1)(A) only apply to manufacturers and Importers of chemical substances; processors of chemi cal substances are not required to give pre manufacture notification on new chemical substances. Therefore, processors are not sub ject to the initial inventory. If processors were subject to the initial inventory, the Agency expects that the num ber of respondents would Increase ten-fold. Moreover, the Agency expects the list of chemical substances reported by manufac turers and importers to contain over 95 per cent of the chemical substances which are manufactured or processed for a commercial purpose in the United States. Accordingly, by making processors and users of chemical sub ufacturer or importer" with respect to every stances subject to only the revised inven chemical manufactured. This would be an tory. the Agency will avoid duplicative re unnecessary burden. porting and substantial delays in publica Comment 26: Including a volume of pro tion of the Inventory. The Agency will not duction limit as part of the definition of process anr reports submitted for the initial `small manufacturer or importer" is con Inventory by processors or users of chemical sistent with the Act and wiil give EPA at substances. least a rough estimate of the quantities of It is a prohibited act under section 15(2) chemicals produced. of TSCA for a person to use for a commer Response: As discussed in comment 24. cial purpose a chemical substance which he in determining an appropriate definition of had reason to know was manufactured in "small manufacturer or importer." EPA con violation of section 5. The Agency has an sidered the value of and need for this in nounced. however, that section 15(2) with formation with respect to the costs to manu respect to section 5(a)(1)(A) will not be facturers and importers of submitting the aoolied to persons who process or use a information. Production data are to be used chemical substance for a commercial pur primarily in decisions concerning prioritiza pose until publication of the revised inven tion of Agency actions and allocations of tory. Therefore, by reporting during the re Agency resources. Because of this, the porting period for the revised inventory* Agency's need for the information grows as processors of chemical substances will be able production volume increases, thus Justifying to protect themselves from prosecution under an increased burden to small businesses who the statute. produce . large quantities of chemical sub stances. EPA Is requiring reporting of pro duction volumes in excess of 100.000 pounds CHEMICAL SUBSTANCES MANUFACTURED OR PROCESSED FOR A COMMERCIAL PURPOSE from all companies. Under these final regu Comment 29: The definition of the term lations, reporting production volumes should "manufacture for a commercial purpose," not be burdensome, especially for those sub should be modified to exclude the manufac stances manufactured In substantial quan ture of a chemical substance in small quan tities. tities for research and development. Comment 27: EPA should define the term Response: The Administrator disagrees "small manufacturer" without respect to with this comment. Chemical substances whether a manufacturer is owned or con which are manufactured for research and trolled by another company. A manufacturer development are "manufactured for com who meets the basic criterion should be mercial purposes" within the meaning of considered a "small manufacturer." even If TSCA and are appropriately Included under the manufacturer's company is owned or this definition. However, if these substances controlled by another company. are produced solely in small quantities for Response: The Administrator disagrees research and development they are specifi with this comment. The legislative history cally excluded from the Inventory under sec of TSCA makes It clear that in considering what manufacturers and processors qualify as "small manufacturers and processors." the* Administrator must consider whether the tion 8(b), and are exempt from the pre manufacture notification requirements of section 5(a) by section 5(h) (3) of the Act. Comment 30: Commercial biological prepa rations such as yeasts, bacteria, and fungi company is owned or controlled by another should not be considered "chemical sub company and apply the factors for determin ing "small manufacturers or processors" to both companies. H. Rep. No. 94-1341, 94th Cong., 2nd Sess. 5 < 1976). stances" under TSCA. Response: The Administrator disagrees with this comment. The term chemical sub stance Is defined to mean "any organic or inorganic substance of a particular molecu FEDERAL REGISTER, VQL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64585 lar Identity including any combination occurring in nature." This definition does not exclude life forms which may be manu factured for commercial purposes and noth ing in the legislative history would suggest otherwise. rfCLCSIONS TO THE DEFINtTlOH OF CHEMICAL *" erneTAMrK Mixtures Comment 31: EPA should clarify that manufacturers, not processors, have the re sponsibility for reporting the component chemical substances of a mixture. Response: EPA believes that these regu lations clarify that only manufacturers of chemical substances must report for the initial inventory. In fact, processors are not subject to the initial inventory. Processors. Including manufacturers of mixtures, may report for the "revised" Inventory. Comment 32: Multi-nutrient "mixed fer tilizers" that could have been prepared by physically blending dry products such as urea, superphosphate, and potash, should be considered mixtures, regardless of whether they are produced by physically mixing or by a method that Involves a chemical re action. such as by combining liquid am monium phosphate and granulating with potash. Response: The Administrator agrees with this comment and will consider multlnutrlent "mixed fertilizers" as mixtures of the Ingredients being mixed. Comment 33: Manufacturers of alloys In cluding steel, glasses, ceramics, enamels, Portland cement, and similar combinations of chemical substances should not be re quired to report for the Inventory. Response: The Administrator agrees with this comment. Alloys, inorganic glasses, ce ramics, frits, and cements, including Port land cement, are mixtures under TSCA; manufacturers of these products are not re quired to report them. However, as stated In a note at 710.4(c). the exclusion of these products applies only to the mixture and not to the chemical substances of which the mixture is comprised. Thus, the metals In the case of alloys, or oxides in the case of glasses and ceramics, and any additives or components other than Impurities, should be included on the inventory. The manu facturers of the metals, oxides, and additives would be responsible for reporting them. Comment 34: "Hydrates" and "hydrated ions" should be considered "mixtures." Response: The Administrator agrees with this comment and has defined the term "mixture" to include "hydrates." Hydrated forms of chemical substances are accordingly exempt from the inventory. The anhydrous chemical substances, however, should be In cluded. Thus the manufacturer of hydrated copper sulfate, CuSo, (H,,0),,f would report that anhydrous form, CuSO<. for the Inven tory. As clarified in the preamble to the March 9 regulations, this provision does not apply to the product of discrete chemical re actions in which either water or a solvent is a reactant, e.g., water reacting with an ester to form an acid and an alcohol. Similarly, metal hydroxides formed by the reactions of metal oxides with water are not con sidered to be hydrates. Comment 35: If a person combines two or more chemical substances to produce a "mix ture." the person should be considered a "manufacturer of the mixture." not a "proc essor of a chemical substance." Response: The Administrator disagrees with this comment. A person who combines two chemical substances to produce a mix ture," the person should be considered a turer of the mixture" or a "processor of the chemical substance." For the purposes of these regulations, regardless of how such a person Is characterized, he may only re port during the reporting period for the re vised inventory. The Agency recognizes that the Congress in section 8(a) established a different stand ard for requiring reporting and retention of information on mixtures than on chemical substances. EPA does not Intend to require reporting on mixtures from either their manufacurers or processors when informa tion concerning the chemical substances which comprise the mixture Is adequate for the Agency's purposes. Comment 36: The definition of the term "mixture" should be expanded to include (1) incidental reaction products, (2) some chemical substances, (3) chemical sub stances which are the result of a chemical reaction that occurs upon use of certain chemical substances, such as curable plastic or rubber molding compounds, or other sub stances which are formed during the manu facture of an article, and (4) chemical sub stances which occur as the result of a chemical reaction when specified substances including, for example, a stabilizer, color ant, or antioxidant, function as Intended, or when a chemical substance which is solely Intended to Impart specific physico-chemical characteristics, functions as Intended. Response: The Administrator disagrees that the substances encompassed within this comment are "mixtures" within the meaning of TSCA. EPA believes that each of the reac tion products is a "chemical substance" .for the purposes of TSCA and that the chemical substance is manufactured or processed for a commercial purpose within the meaning of section 8 of the Act. However, In keeping with the legislative history of the Act, 710.4(d) excludes all these substances from the Inventory because they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purposes separate from the mix ture or article of which they may be a part. In addition, they are not subject to the pre manufacture notification requirements of section 5. The Administrator may in the fu ture impose a section 8(a) reporting rule as to these substances. In addition, the pro visions of sections 8(c), 8(d) and 8(e) are applicable to these substances. . The term "mixture" under TSCA has a meaning which Is different from Its usual meaning In some respects. Many composi tions commonly considered to be mixtures are "chemical substances" rather than "mix tures" for purposes of these regulations. A combination of two or more chemical substances is itself a "chemical substance" for purposes of these regulations unless it falls within the specific definition of the term "mixture." In general, a combination of two or more chemical substances is a "mixture" If they have been combined by actually mixing them together. If, however, the combination occurs In nature, it Is a "chemical substance" and is not a "mixture." If, further, the combina tion is prepared by a chemical reaction, it Is a "chemical substance" and not a "mix ture," unless the combination could actu ally have been manufactured for commercial purposes at this time without a chemical reaction e.g., by mixing Its separate compo nents with each other. Note.--Hydrates and hydrated ions are treated separately, and are discussed in com ment 34. Pesticides and Foods, Food Additives, Drugs, Cosmetics and Devices Comment 37: Various commenters stated that a substance should be excluded from TSCA If it is intended for use solely as a pesticide, food, food additive, drug, cosmetic, or device. Response: The Administrator agrees with these comments. Pesticides are regulated under the Federal Insecticide, Fungicide and Rodentlclde Act (FIFRA), as amended, 7 USC 136 et seq. Foods, food additives, drugs, cosmetics, and devices are regulated under the Federal Food, Drug and Cosmetic Act (FFDCA), 21 USC 321 et seq. If the manu facturing, processing, distribution, or use of a substance is regulated under either FIFRA or FFDCA, the substance would not be sub ject to regulation under TSCA Insofar as it is actually manufactured, processed or dis tributed in commerce for use as a pesticide, food, food additive, drug, cosmetic or device. If a substance has multiple uses only some of which are regulated under FIFRA or FFDCA, the manufacture, processing, distri bution, and use, of the substance for the remaining uses would come within the Ju risdiction of TSCA, In cases where a sub stance is manufactured, processed, or dis tributed for undifferentiated uses, the sub stance will be presumed to be subject to TSCA for the purposes of these regulations. EPA recognizes that the interrelationship of TSCA, FIFRA. and FFDCA Is complex and that Jurisdictional Issues need further ex ploration In light of the various types of regulatory situations that may arise and the Congressional intent of avoiding both dual Jurisdiction and regulatory gaps. EPA believes that an appropriate resolution has been made in this particular instance. Comment 38: A substance should be consid ered a pesticide at the time that an appli cation for an experimental use permit or an apolicatlon for registration Is submitted. Response: The Administrator agrees with this comment. If a manufacturer, processor, or distributor of a substance expects to re ceive benefit In pest control from Its use. It would be considered a pesticide within the meaning of FIFRA. Submission of an applica tion for an experimental use permit (FIFRA) section 5. 40 CFR Part 172) or an applica tion for registration (FIFRA) section 3, 40 CFR Part 162) will be evidence that the sub stance Is a "pesticide" within the meaning of FIFRA. Prior to this stage, the substance will be presumed to be a chemical substance within the meaning of TSCA. Therefore, any particular substance will first be subject to the provisions of TSCA and then, the pro visions of FIFRA. Implementation of this approach will not pose an unreasonable burden on registrants of pesticide products. The substance will be considered a "chemical substance" under TSCA at the research and development stage. Assuming that the substance is only pro duced In small quantities for research and de velopment (as defined in these rules), under the exemption of section 5(h)(3), the TSCA premanufacture notification requirements would not apply. The Administrator could re quire that all persons engaged in experimen tation, research or analysis of the substance be notified of any risk to health which may be associated with the substance. This is entirely in keeping with the purposes of TSCA. In addition, the Administrator could take regulatory action on the substance under TSCA sections 4. 6 or 7, and could require reporting under section 8(a)(1)(B). The Agency recognizes the Importance of research and development and does not intend to Im pede such innovation unnecessarily. Chemi cals in the research and development stage are generally handled by technically qualified persons and only In small quantities. Accord ingly, although the Agency may take regula tory action (including labelling and disposal requirements) in order to regulate inad vertent mishandling of research chemicals by an untrained person and Inadvertent ex posure to the environment of the research chemical, submission of test data and exten sive regulation of the uses of the substance FEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 6458$ RULES AND REGULATIONS would normally be limited to situations in volving significant exposure. In the case of a research chemical which becomes a pesticide, these latter areas of concern would be ad dressed .under FIFRA. Commont 39 Various commenters main tained that raw materials, intermediates, and inert ingredients produced or used in the manufacture of a pesticide should be con sidered "pesticides'* and excluded from regu lation under TSCA. Other commenters argued that raw materials and intermediates pro duced or used In the manufacture of a pesti cide are not "pesticides." are not covered under FIFRA. and should be regulated under TSCA. Response The Administrator agrees that raw materials, intermediates and inert in gredients produced or used in the manufac ture of a pesticide are substances or mixtures which ran. be regulated under TSCA. In order to be considered a pesticide, a sub stance must be intended for use as a pesti cide. Raw materials, intermediates, and inert ingredients produced or used in the manu facture of a pesticide are not themselves reg ulated under FIFRA (unless they happen to be pesticides themselves! and. therefore, are subject to TSCA. The pesticide regulations at 40 CFR 162 4 are consistent with, this view. A manufacturing use Droduct is considered a pesticide. (40 CFR 162.4(b)(3)); 'an inter mediate substance intended for the produc tion of a pesticide product by chemical reac tion with other substances is not considered r. pesticide. 140 CFR 162.4(0 16)). The legislative history of TSCA also sup ports this view. TSCA was enacted to pro vide protection from harmful chemicals where legal authority was previously inade quate,. cumbersome or inefficient. Congress intended to avoid the possibility that the risks from a chemical would not be subject to regulation. S. Rep. No. 94-698. 94th Cong., 2d Sess. 5 (1976). H. Rep. No. 94-1341. 94th Cong.. 2d Sess. 6 (1976). In addition, Sena tor Allen of the Senate Committee on Agri culture and Forestry In attempting to con form the language of TSCA to that of FIFRA specifically addressed the interface between FIFRA and TSCA stating: "* * any chemi cal or toxic substance would first be subject to the provisions of iTSCA) and yet when it becomes a component of a pesticide, it would be subject to FIFRA. In many instances the manufacturer and registrant of the compo nent is also the manufacturer and registrant of the pesticide." Committee on Interstate and Foreign Commerce. 94th Cong . 2d Sess., Legislative History of the Toxic Substances Control Act 232 (1976). A raw material, Inter mediate. or Inert ingredient which is not itself a pesticide would, accordingly, be a chemical substance within the Jurisdiction of TSCA; it would come within the jurisdiction ol FIFRA when it becomes a component of a pesticide product. The manufacturer, processor, or distribu tor ot the chemical substance who does not also maufacture. process or distribute a pesti cide product will not be subject to tne dual Jurisdiction of T3CA and FIFRA. That per son will only be subject to TSCA. The manu facturer. processor, and distributor of the raw material, intermediate, or inert ingredi ent who also manufactures the pesticide protract will be subject to the Jurisdiction of both acts. TSCA and it* legislative history contemplates this, and EPA has no discretion to reach a different result since a raw mate rial. intermediate, or inert ingredient (which is not itself a pesticide) cannot be regulated under FIFRA until it becomes a component of a pesticide product. As a matter of policy, however. EPA does not intend to impose duplicative requirements cn these sub stances. Comment 40: A substance should be con search and development" even if they ore dis sidered a food, food additive, drug, cosmetic tributed in commerce. or device at the time that the Food and Comment 44: Numerical limits should be Drug Administration (FDA) regulates the included in the definition of small quantities substance. for research and development. Response: The Administrator agrees with Response: The Administrator considered this comment. As soon as the FDA regulates establishing upper limits for small quantities a product, its manufacture, processing, or for research and development and found that distribution in commerce soiely for a FDA different values might have to be assigned regulated use will be excluded from the Juris for various groups of stibstances depending diction of TSCA. The FDA gives as examples upon their physlc&l/chemical characteristics of such points In time: when an application and intended uses. For example, many plas for exemption for an investigational use of tics and fibers are commonly produced in a new drug is submitted (FFDCA 505(a); 100.000 pound quantities during the develop 21 CFR Part 312); when an application for mental phase, while additives or minor use exemption for investigational use of a new substances may be manufactured in a few animal drug is submitted (FFDCA 512ia); thousand pounds or less for research and de 21 CFR Part 511); and when an application velopment purposes. After compilation of the for exemption for investigational use of a inventory, the Agency will consider develop device is submitted (FFDCA 520(g'; 21 ing a schedule of quantities to define small CFR Part 812. as proposed, 41 FR 35282, quantities for different chemical substances August 20. 1976). and different purposes. Comment 41: Intermediates and catalysts intended solely for use in the production of a food, food additive, drug, cosmetic, or device are excluded from regulation under TSCA. Response: The Administrator agrees with this comment. The definitions of the FFDCA provide that chemical substances which are intended for use as a component of a food, food additive, drug, cosmetic, or device are encompassed within the meaning of such terms, respectively. The FDA considers in termediates and catalysts to be such compo nents. Therefore, they are subject to regula tion under the FFDCA. Any such substance is excluded from regulation under TSCA in sofar as it is actually manufactured proc essed or distributed in commerce solely for use in the.production of a food, food additive, drug, cosmetic or device. Comment 42: Substances which are ap proved for use by the Food and Drug Admin istration as foods or food additives, should be excluded from further regulation under TSCA even when used for commercial (non food) uses. Response: As discussed in response to com ment 37. if a substance has multiple uses only some of which are regulated under the FFDCA. the manufacturing, processing, dis tribution. and use of the substance for the remaining uses comes within the Jurisdiction of TSCA. Under these regulations, that sub stance should be reported for the inventory. For these reporting requirements, however, EPA will in large part rely on the qualita tive test contained in the definition at $ 710 2<y). In response to this comment, as pro vided in a note to the definition, if a sub stance is manufactured or imported in quantities of less than one thousand pounds, annually, it will be presumed to be for re search and development purposes. If a man ufacturer wishes to report for inclusion on the inventory a chemical substance which is manufactured for commercial purposes in quantities of less than one thousand pounds, annually, he must be able to certify that the substance is used for purposes other than for research and development. After the publi cation of the revised Inventory, in order to qualify as a "small quantity for research or development." these quantities must be used by. or directly under the supervision of. a technically qualified individual. Comment 45: The exemption for "small quantities" should not extend to research or analysis of chemical substances for the de velopment of a product. The exemption should apply only to research in a laboratory and not to situations where production workers are exposed. Response: The Administrator disagrees with this comment. The legislative history of the Act makes clear that Congress in tended the exemption for "small quantities" EPA does not intend to impose duplicative to extend to chemical substances in the de requirements on manufacturers and proces velopmental period and not only to research sors subject to regulation under another chemicals In a laboratory. H.R. Rep. No. 94 Federal authority Accordingly. EPA will con 1341, 94th Cong., 2d Sess. 29-30 (1976). The sult with FDA or any other Federal agency, Congress contemplated that during the re as appropriate, prior to taking regulatory search and development phase, a chemical action on substances which are also regulated substance would be within the control of under other authorities. technically qualified individuals who would CHEMICAL SUBSTANCES EXCLUDED FROM THE INVENTORY ponreciate the risks from exposure to the substance and be able to minimize such risks. The regulations provide that a compound wiil Small Quantities for Research and only qualify for the "small quantities" ex Development e-notion if it is used by. or directly under the Comment 43: The exemption for "small quantities for research and development" should include small quantities used for quality control testing and for development of a chemical substance or product. Response: The Administrator agrees, in part, with this comment. Chemicals used for quality control testing and for the develop ment of a product are considered "small quantities for research and development" if tney fall within the definition provided in <j 710.2iy >. Specifically, they must be manu suoervlsion of, technically qualified tndlvidual(s). The Agency expects this require ment to Drovtde workers in the development of a Droduct the same protections as workers in the laboratory. In addition, section 5(h) (3) of the Act sDeciflcally provides that in order for, a substance to be exempted from the requirements of premanufacture notifi cation. all persons handling the chemical substance for the manufacturer or proces sor must be notified of any risk to health which the manufacturer, processor or the factured or processed iu quantities no greater Administrator has reason to believe may be than reasonably necessary for such purposes associated with it. and, after publication of the revised inven Comment 46: The exemption for "small tory, they must be used by, or directly under quantities" should not extend to chemical the supervision of "technically qualified in substances distributed in commerce. dividual^)a term defined in 710.2(aa). Response: The Administrator disagrees Substances can be "^mall quantities for re with this comment. Congress recognized that FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64587 a manufacturer may not be able to evaluate fully a potential product In bouse. So long as the research and evaluation of the sub stance is conducted by or under the direct supervision of persons technically qualified to analyze and evaluate the physical, chemi cal. and performance characteristics of the substance, the Congress intended the ex emption to apply. H.R. Rep. No. 94--1341, 94th Cong.. 2d Sess. 30 < 1976). Comment 47: After the effective date of the premanufacture notification require ments. EPA should require all research and development chemicals to be labeled rather than require a 'certification of use'* state ment by a customer upon each sale. Response: The Agency recognizes that it may be unnecessarily burdensome to require customers to certify upon each sale (or even annually) that the chemical substances they purchase are for research and develop ment only. EPA is considering imposing a labeling requirement on all research and de velopment chemicals (such as "For Research And Development Use Only") and requiring distributors of such chemicals to Include statements in their catalogs and sales liter ature detailing the restrictions on use. Comment 48: EPA should clarify the re sponsibilities under these regulations of per sons who manufacture or Import chemical substances solely In small quantities for re search and development. Response: Chemical substances manufac tured, imported, or processed solely in small quantities for research and develop ment as defined at 5 710.2(y) are excluded from reporting for the inventory under 710.4(c)(3). As discussed above, if a per son manufactures or Imports a chemical substance In quantities of less than one thousand pounds annually, the substance Is presumed to be for research and develop ment. In such a case. In order to report the substance a manufacturer or Importer must be able to certify that the substance is being used for purposes other than research and development. With respect to quantities greater than one thousand pounds, manufacturers and importers are not required to obtain certi fication from their customers concerning the Intended use of such chemicals. How ever. unless a manufacturer or Importer knows that a customer Is using a chemical substance for other than research purposes, he should not report that chemical sub stance. The special reporting period after publication of the Initial inventory is exDressly to provide an opportunity for people to supplement the initial Inventory with chemical substances which are manufactured or processed for commercial purposes but which were not reported by manufacturers or importers. The customers of a company selling primarily research chemical sub stances could report any chemical substance that belongs on the inventory at that time. Comment 49: The provision that small quantities for research and development must be used by. or directly under the supervision of a technically qualified Indi vidual. should be deleted. Response: The Administrator disagrees with this comment. As discussed in response to comments 43. 44. 45. and 46 above. Con gress clearly intended research and develop ment chemicals, that are exempted from the inventory and from premanufacture notifi cation requirements, to be used only by. or under the supervision of technically quali fied individuals. Comment 50: Professional certification should be added as a factor which would establish that a person is "technically quali fied." Response: EPA believes that this factor Is already Included In the definition of tech nically qualified-individual. EPA presumes 94-698. 94th Cong. 2d Sess. 19 (1976). Ac that professional certification would be cordingly. section 710.4(d)(2) of these regu based on the education, training, or experi lations excludes these substances from these ence of the individual. Accordingly, it would reauirements. be redundant to include professional certi Comment 54: Should slags which have fication as a separate factor. Persons could some commercial value and that are by cite their professional qualifications as evi products In the manufacture of another sub dence of being a "technically qualified indi stance be reported for the inventory? vidual." Response: Section 710.4(d)(2) of these Comment 51: Can the responsibilities In regulations provides that byproducts that cluded within the definition of "technically have some specific kinds of commercial value qualified Individual" be delegated to more may be reported for the Inventory, although than one person? there Is no requirement that they be so re Response: The Agenqy recognizes that ported. Byproducts that have no commer some manufacturers may designate an Indi cial value may not be reported for the in vidual other than the person actually con ventory. ducting or directly supervising the research Comment 55: Persons who extract com or development as the person responsible for ponent chemical substances from byproducts making safety assessments and clearances should not be required to report those chemi with respect to the procurement, storage, cal substances. use. and disposal of the chemical substance. Response: The Administrator agrees with Such responsibilities can be delegated, so this comment. Persons who recover chemical long as all phases of the research and devel substances from byproducts of the manufac opment of a product are conducted, or di ture or processing of other chemical sub rectly supervised by a person who because of - stances. mixtures, or articles would be proc his education, training, or experience, or a essors of the chemical substances and need combination of these factors. Is capable of not report for the inventory. There is no appreciating the health and environmental requirement that these persons report any risks associated with the chemical substance. chemical substance which is extracted or For example, one person may be respon separated from a byproduct, including by sible for analyzing the properties of a chem means of heat or a chemical reaction. If the ical substance used as a glue to back a rug, chemical substance that Is recovered Is while a second person may have respon actually present In the byproduct or was an sibility for determining how to dispose of intermediate used in the manufacture of the rug samples that contain the experi the byproduct, and if also, to the best of mental glue. Similarly, there may be a duly the knowledge of the person recovering the authorized individual responsible for pro substance, the manufacturer of the sub curement of research chemical substances stance Ls reporting the substance for Inclu who Is different from the technically quali sion on the inventory. fied individuals who conduct the experi ments with those chemical substances. So long as each of these persons Is professionally Qualified, the "technically qualified indivi dual" definition will be fulfilled. Byproducts Articles Comment 56: Can articles be reported for the Inventory? Response: Articles as defined at 5 710.2(f) will not be Included on the inventory. The Inventory ls a list of chemical substances Comment 52: All byproducts should be re quired to be reported for the inventory. Response: The Administrator disagrees with this comment. As a matter of policy, the Agency has decided that byproducts which have no commercial purpose should not be reported for the inventory. And, as Is discussed in response to comment 54. by products which have some commercial value are not required to be reported for the in ventory. Insofar as these wastes are hazard ous, EPA intends to require reporting of them under the Resource Conservation and Re covery Act (Pub. L. 94-580) next spring, or under TSCA section 8(a) (2) during subse quent phases of reporting. Moreover, the pro visions of TSCA sections 8(c), 8(d). and 8(e) are applicable to byproducts and the Agency will use the authorities of TSCA sections 4, 6, and 7 to prevent and reduce any unreason able risks posed by byproducts. Comment 53: The definition of byproduct In the March 9, 1977. proposal Is confusing. Chemical substances formed as a result of secondary chemical reactions, including those that occur uoon end-use or in storage, are not "byproducts." Response: EPA recognizes that the defi nition of byproduct in the March 9 proposal was confusing. The August 2 proposal and these final regulations (5 710.2(g)) have re defined "byproduct" to Include only those chemical substances produced without sepa rate commercial intent during the manufac ture or processing of other chemical sub stances or mixtures. The legislative history of TSCA makes clear that these secondary chemical sub stances are not to be subject to the Inventory manufactured or processed for a commercial purpose In the United States. Chemical sub stances of which articles are comprised can, however, be reported for the Inventory. Comment 57: What are the reporting re quirements with respect to manufactured Items containing fluids or particles? Response: The definition of "article" at 5 710.2 excludes fluids and particles regard less of shape or design. Accordingly, all fluids and particles will either be a "mixture" or "chemical substance" for the purposes of TSCA. Any fluid or particle which is a chemi cal substance should be reported for the In ventory. See also response to comment 21. Comment 58: The definition of "article" should be modified to Include products such as films and batteries which undergo chem ical changes during their end uses. Response: The Administrator agrees with this comment and .has amended clause 3 of the definition to include within the mean ing of "article" a manufactured item "which either has no change of chemical composi tion during Its end-use or only those changes in composition which have no commercial purpose separate from the article of which It is a part and that may occur as de scribed in 5 710.4(d)(5)." The provision In 5 710.4 is an exoluslon for chemical sub stances which are the result of reactions that may occur upon end-use of other chem ical substances, mixtures, or articles. Under this revised approach, batteries, photographic films, matches, flares, ablative nose cones, brake linings, and other such products are considered "articles." Comment 59: Fibers, filaments, and whis kers should be considered articles. and premanufacture notification require Response: As defined in 5 710.2(f), fibrous ments because they are not manufactured materials may be considered articles If (1) fer commercial purposes per se. S. Rep. No. their end-use functions depend In whole or FEDERAL REGISTER, VOL. 42, NO. 247---FRIDAY, DECEMBER 23, 1977 64588 RULES AND REGULATIONS in part upon their shape or design and (2) they are functional in their end-use with out a change of chemical composition ex cept for changes that have no commercial purpose separate from the articles of which they are a part. If a person shapes a chemical substance into a filament or fiber, he would be a processor of that substance. The chem ical substance would be reportable by the manufacturer. The filament or fiber or whis ker would be an article and could not be reported. However. If that fibrous material was intended to be used as an intermediate in the manufacture of another chemical substance, it would not be considered an article- It would be considered a chemical substance <or mixture). Particles are not articles whether they are round or asym metric. If a whisker or other fibrous mate rial may be used as a particle in its subse quent processing, it would not be considered an article. Comment 60: Chemical substances used In the finishing process of an article should not be excluded from the inventory. Dyes and fire retardants are two examples of sub stances which should be reported. Response: The Administrator agrees with this comment. There has been some con fusion over the intent of the exclusion In 5710.5(d) f6) of these regulations. The ex clusion is for chemical substances that are not manufactured for distribution in com merce as chemical substances per se and have no commercial purpose separate from the mixture or article of which they may be part. Dyes and fire retardants are~chemlcal sub stances, manufactured for distribution in commerce as chemical substances, and there fore do have a separate commercial pur pose. These substances should be reported by their manufacturers for inclusion on the Inventory. The exclusion In 5 710.4(d)(6) Is for chemical substances formed when the dye or fire retardant reacts with fibers of a garment or other article upon end-use of those substances by a processor. These reac tion products must not be reported. Impurities Comment 61: Chemical substances should be listed on the inventory with respect to t.heir Impurities. Response: The Administrator disagrees with this comment. The Agency has de*rmined that as a matter of policy, this first inventory should not distinguish among chemical substances which are Identical ex cept With respect to their impurities. The Agency recognizes the potential hazards of some impurities and Intends to use the al ternative authorities of sections 4, 6, 7, and 8 to prevent and reduce any unreasonable risks posed by impurities. In addition, In the future EPA may revise the inventory to take Impurities of a chemical substance Into account. CHEMICAL SUBSTANCES INCLUDED IN THE INVENTORY Comment 62: Since customer demand runs in cycles, some provision should be made to allow companies to report chemical sub stances which they manufactured for a com mercial purpose more than three years ago and plan to produce again. Response. The Administrator agrees in part with this comment. Section 8(b) of TSCA provides that a chemical substance may not be included on the inventory if it was not manufactured or processed within three years before the effective date of these regulations. Accordingly. 710.3(a) (3) (ii) of these reg ulations, provides that if a person manufac tured a substance for a commercial purpose before January 1, 1975, he may still report the substance for the.Inventory if he certi fies that the substance was processed after January 1, 1976. If a manufacturer neither manufactured a chemical substance nor can certify that the substance was processed within the past three years, he may not re port the substance for the Inventory, even if he plans to.produce It again In the future. If the substance Is not reported for the in ventory by the manufacturer or by another manufacturer or processor, manufacturers will have to submit premanufacture notifica tion on the substance 90 days before manu facturing It again. Comment 63: Manufactures should be able to report chemical substances manu factured since July 1, 1974, as provided in the March 9, 1977, proposal. Response: The Administrator disagrees with this comment. The July 1, 1974, date was included In the March 9, 1977, pro posal on the assumption that final Inventory reporting rules would be promulgated by July 1977. Section 8(b) of TSCA clearly pro vides that the Inventory may not Include any chemical substance which was not manufac tured or processed within 3 years of the ef fective date of these rules. As discussed In re sponse to comment S3, a manufacturer may report a substance for the Inventory If It was manufactured before January 1, 1976, so long as It was processed after January 1, 1975. Test Marketing Comment 64: The Administrator has no authority to exclude chemical substances presently undergoing test marketing from the initial Inventory. Response: Any chemical substance which Is manufactured or imported for'test mar keting purposes Is eligible for Inclusion on the Inventory. This Is made clear by the defi nition of the term "manufacture or Import 'for commercial purposes' " at 5 7l0.3(p). Af ter the effective date of the premanufacture notification requirements of section 5(a) (1) (A), a manufacturer may not test market a new chemical substance without first either providing the premanufacture notification required by that section or obtaining an exemption from the requirement under sec tion 5(h) (1) of the Act. Comment 65: The critical factor In dis tinguishing the "development phase" of a product from Its "test marketing" phase Is that the latter phase contemplates a sale. The word "sale" must be Included In the defini tion of "test marketing" because accepted and ordinary usage of the phrase Involves the sale of a product under practical competitive conditions. Response: The Administrator does not agree with this comment. Sale of a product does not always distinguish Its development phase from Its test marketing phase. The Congress itself recognized that "the fact that the other industrial user may pay the costs for the substance does not necessarily signal the end of the development period." HR. Rep. No. 94-1341, 94th Cong., 2d Sess. 30 (1976). Pot the purposes of these regulations, re search and development activity will be differentiated from test marketing primarily by the greater degree of control maintained by the manufacturer and the greater techni cal qualifications of those handling and supervising the use of the substance during the research and development phase. Distri bution of the product during the test mar keting phase generally removes, the product, its use, and its disposal from the direct supervision of the manufacturer. (See re sponse to comments 43-51.) Comment 66: EPA should place restrictions on both the population and geography which may be exposed to products in test market ing and should require labeling of products to indicate potential hazards. Response: The Administrator has author ity under section 5(h)(1). to Impose such restrictions on test marketing of a chemi cal substance as are necessary prior to ex empting the chemical from the premanufac ture notification requirements. In addition, the Administrator will use the authorities of sections 4. 6, and 7 of the Act to prevent unreasonable risks to man and the environ ment. Intermediates Comment 67: The term "Intermediate" should exclude intermediates that are merely "lsolatable", and are never encountered In the environment. The Identification of these intermediates will often require highly trained chemists and will significantly In crease the costs of complying with the re porting requirements. Response: The Administrator agrees with this comment and the definition of "Inter mediate" at 5 710.3(n) has been amended accordingly. Chemical substances which are not <removed from the equipment In which they are manufactured are not considered "intermediates" for the purposes of these regulations and are excluded from the inven tory by { 710.5(d) (8). EPA will require noti fication under section 5 for any chemical substance which is not on the inventory and which, after the date of the premanufacture notification requirements. Is Isolated, or In tentionally removed from the equipment In which It was manufactured. A manufacturer may, however, apply tor an exemption from this requirement under section 5(h)(5) If the Intermediate exists temporarily and there is no, and will not be any, human or environ mental exposure. Chemical substances ex cluded from the Inventory by S 710.4(d) (8) are considered to be manufactured or proc essed for a commercial purpose for the pur poses of section 8 of the Act. Comment 66: The definition of "Inter mediate" In the March 9, 1977 proposed regu lations Is more descriptive of an "Impurity." An "intermediate" should refer to a chemi cal substance that Is both created and totally consumed during the chemical re action process. This description would pro vide a meaningful distinction between an "intermediate," a "byproduct," and an "impurity." Response: The Administrator agrees In part with this comment and has substan tially revised the definition of "Intermedi ate." The purpose of the definitions under these regulations Is to clarify which chemi cal substances are Included and which are excluded from the Inventory. The Adminis trator does not agree that the term "Inter mediate" should be restricted to chemical substances that are totally consumed In chemical reaction processes. A chemical sub stance may be an Intermediate and also ap pear later as a byproduct or aa an Impurity. In such circumstances, the substance should be reported for the Inventory. Under these definitions, the essential dif ference between a byproduct and an Inter mediate Is that the Intermediate is con sumed. In whole or In part. In a chemical reaction used for the intentional manufac ture of other chemical substances, or is In tentionally present for the purpose of alter ing the rate of such reaction(s). A byprod uct my be formed and then consumed in whole or in part during the reaction se quence but is not an "intermediate" unless it is consumed in whole or in part In chem ical reactions used for the intentional man ufacture of other chemical substances or is intended to alter the rate of such reactions. Impurities are defined as chemical sub stances which are unintentionally present with another chemical substance. While in termediates often appear as trace Impurities in a final product, they are In general dis- FEDERAl REGISTER, VOl. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64589 tlnguished from impurities in that they serve an intentional purpose In a reaction sequence. Comment 69: Chain transfer agents or cross linking agents used in the manufac ture of polymers should be considered inter mediates. Response: The Administrator agrees with this comment. Cross linking agents and chain transfer agents which are used in the manufacture of polymers are considered to be processed for commercial purposes and should be included on the inventory. The processor who buys- such substances for use in the manufacture of polymers need not report such substances. However, he should ensure that the substances are included on the initial inventory or report these sub stances during the special reporting period for the revised inventory. Section 710.5(c) requires listing in the description of a polymer at least those mon omers used at greater than two percent (by weight! In the manufacture of the polymer. In a similar fashion, a manufacturer would list, as part of the polymer description, those cross linking, chain transfer and other re active agents which are present at greater than two percent (by weight) In the manu facture of the polymer. Additives such as plasticizers and emulsifiers which are only entrained in the polymer are considered to be components of a mixture and should not be considered to be components of the poly mer. See response to comments 77-82 on reporting of polymers. Comment 70: In the manufacture of poly mers, there are literally thousands of Inter mediates deliberately present in the reaction sequence. The process may be interrupted, occasionally, for examination and testing, at which point chemically reacted substances are removed. Such substances should not be considered `'intermediates" for the purposes of these regulations and should not be re ported for the inventory. Response: The Administrator agrees. In part, with this comment. If a chemical sub stance satisfies the definition of "interme diate" at 7lo.2m) of these regulations, for the purposes of these regulations, It is an intermediate. However, an intermediate may also fall within the exclusion from these regulations at i 710.4(c) (3) for "small quan tities for research and development." If an intermediate" is a "small quantity for re search and development" it is excluded from the inventory. Hence the removal of small quantities of alchemical substance from the equipment in which it was manufactured does not make that chemical substance a reportable intermediate" if the amount re moved is used solely for testing or research purposes described in i 710.2(y). Comment 71: The inclusion of "Intention ally present catalysts" under the definition of intermediates in the March 9 proposal Is confusing. Response: The Administrator agrees with this comment and has revised the term "in termediate" at i? 7i0.2(n) to Include "any chemical substance which is lntentially pres ent for the purpose of altering the rate of (such) chemical reaction(s)This definition of the term "Intermediate" is consistent with common usage. It considers "catalysts" as "intermediates". Naturally Occurring Substances Comment 72: Which of the following sub stances would be considered "naturally oc curring substances." and therefore be ex cluded from the reporting requirements: natural latex; "natural rubber"; enzymes; and calcinated clays? Response: The natural latex obtained from certain trees is considered a naturally oc* currtng substance. However, the "natural rubber" which is formed after chemical co- agul&nts are added to the latex would not be considered In the category of "naturally occurring substances". Thus, importers of "natural rubber" must report under these regulations. Enzymes are not included in this category unless they were extracted from na ture only by the means described in $ 710.4 (b) And, calcinated clays which are formed by heating naturally occurring clay are not included In this category because such heat ing Is not done solely to remove water. Comment 73: The category of "naturally occurring substances" should be expanded to Include those substances which are ex tracted from other naturally occurring sub stances using any solvent, not just water. Response: The Administrator disagrees with this comment. EPA has decided that the category should contain only those sub stances which are removed from nature es sentially by natural means. Using water to extract a chemical substance from a nat urally occurring substance is considered a natural means of removal. Using other sol vents is not considered a natural means of removal. Comment 74: The category for naturally occurring substances should include sub stances that are processed by electrostatic means. Response: The Administrator agrees with this comment. In an electrostatic separation, small particles are removed from a liquid or gas stream. The process is essentially analogous to a filtration or gravitational separation. Substances which are processed by this means fall within the naturally oc curring substances category. Comment 75: How does EPA intend to regulate naturally occurring chemical sub stances which may be harmful? Response: The Agency will use the au thorities contained in section 8(a> of the statute to require reporting on a selective basis from manufacturers and processors of naturally occurring chemical substances. In addition, the Agency will use the authorities of secttons 4. 6, and 7 of TSCA to identify and regulate any unreasonable risks to health or the environment presented by naturally oc curring chemical substances. INVENTORY REPORTING PROCEDURES Comment 76: EPA should form a group which can help Industry answer specific ques tions concerning filling out the reporting forms. Responses should be available within 10 days and signed by an authorized indi vidual. Response: The Office of Industry Assist ance in the Office of Toxic Substances and the staffs of the Agency's Regional offices will be prepared to answer specific questions con cerning the Inventory reporting require ments. EPA will make every effort to Tespond to inquiries as quickly as possible. .Reporting of Polymers Comment 77: Polymers should be required to be identified with respeet to their con stituent monomers present at greater than two percent with the option of reporting these monomers present at less than two per cent. All monomers used in the manufacture of the polymer should be reported for the inventory. Response: The Administrator agrees with this comment. Section 710.5(c) of the regu lations is written to accomplish this result. Comment 78: Some commenters argued that polymers should be required to be iden tified with respect to the constituent mono mers present at greater than five percent. Other commenters argued that every con stituent monomer of a polymer should be reported. Response: The Administrator disagrees with these comments. In the Interest of hav ing an inventory that accurately reflects the identities of the polymers in commerce, EPA felt that requiring reporting of only those constituent monomers present at five per cent or greater would be unsatisfactory. On the other hand, since every monomer must be identified on the inventory even though not reported as part of a specific polymer, EPA did not believe it was essential to re quire reporting of each polymer with respect to all of its constituent monomers. More over. EPA recognizes important advantages in requiring manufacturers of polymers to identify only those monomers present at two percent or more. First, the principal identities of many polymers that might have been claimed to be confidential if required to be fully disclosed will be included on the Inventory. Further, it is sometimes difficult to distinguish what chemical substances present at less than two percent in a polymer would be appropriately considered a reportable monomer or merely an impurity. Finally, small variations among polymers due to minor process changes, for example, will not be subject to premanufac ture notification provided, the polymer does not contain a new chemical substance. EPA recognizes that for the purpose of evaluating potential toxicity, the proposed description of polymers Is insufficient. EPA intends to obtain detailed Information with respect to specific classes of polymers under section 8(a). In addition, EPA will consider possible refinement of descriptions of poly mers for purposes of the Inventory in the future. However, because potential toxicity may be dependent on properties such as solubility, molecular weight distribution, and crystallinity. It is unlikely that even with further revisions, the listing of monomers would be_sufficient to indicate the relative potential toxicity of the polymers. Finally, these regulations do not exempt from the inventory any chemical substance which is manufactured for commercial pur poses as a monomer, regardless of its per centage use in the manufacture of polymers. Additives which are not intended to be part of polymeric chemical substances should not be reported as part of the description of polymers, but should be Included separately on the inventory as chemical substances. Comment 79; Some numerical molecular weight should be determined for purposes of distinguishing reactive and relatively non reactive polymers and copolymers. Above a certain specified molecular weight, relatively non-reactive polymers should not be listed individually, but only the monomers that comprise these polymers In various combina tions should be listed. Below that weight, each polymer or copolymer should be listed separately with respect to its constituent monomers. Response: The Administrator believes that such an approach should be investigated. While it is not feasible to adopt such an ap proach for the present inventory, EPA may revise the inventory accordingly once an ap propriate test method is adopted to ensure consistency in measuring polymer weights. Comment 80: Any chemical substance known as a polymer should be excluded from the inventory, provided that each constituent monomer and precursor chemical Is reported. Response: The Administrator does not agree with the proposal to exclude reporting of all polymers. EPA does recognize, however, that non-volatile or inert polymers above some particular average molecular weight could perhaps be handled differently. As mentioned In response to comment 79 above, EPA intends to Investigate distinguishing polymers on the basis of their average mo lecular weight and possibly modifying the inventory in the future. Comment 81: How should the weight of a monomer be calculated and what is meant FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 fi|:W . RULES AND REGULATIONS bv a monomer present at a certain weight percent'* of a polymer? .. Response For purpose of the inventory reporting requirements, the. percent (by weight) of a monomer xs the weight of the rr.oncmer charged into the reactor and not the weight incorporated Into the polymer. The weight of the monomer should be ex pressed as a percentage of the weight of the polymeric chemical substance manufactured. Comment 92 If a polymer listed on the inventory ccntams five monomers, for ex- \-ioie. a new polymer with four of those :V.e monomers should not be considered a :-hem::al substance" for the purposes c f shc t :on 5' a i U ) (A). Response- The Administrator disagrees w this comment. If someone created a o--ix :r.er that contained fifty different mono- rr.era* which were added in insignificant quantities merely to include them as part that reported polymer, a manufacturer then create thousands of polymeric combinations baaed on those fifty monomers without reporting them f<?r the inventory or submitting premanufacture notification. Inventory Reporting Forms Comment S3: Ail forms should begin with a certification to the effect that *`to the best of my knowledge and belief. I certify that Response: The Administrator agrees with this comment and has modified the forms accordingly. Comment 84. It should not be necessary to report both chemical names and Chemi cal Abstracts Service (CAS) numbers on Form B. Response: The reason that EPA requires a manufacturer to report both a chemical name and the Chemical Abstract Service Registry number on Form B is to ensure that a manufacturer has reported correctly If EPA required only reporting of the seven digit CAS numbers, EPA would have no means to check whether a manufacturer correctly reported that number. Comment 85 It should be possible to fill cut ail forms on computer print-out or tape. Response: Manufacturers may report chemical substances that have CAS registry numbers by computer print-cut or tape. Instructions? for reportin? m this manner are ..-.eluded in the instruction booklet accom pany ,ng the forms. Comment 86: The instructions for report ing'should make clear that complex, unde fined chemical substances may be reported bv describing the reaction process used to manufacture the substances. Response: EPA recognizes that it is often difficult to describe complex reaction prod ucts whose composition is variable or un known. Many of these substances are com monly described by generic terms such as coal tar shellac, or vegetable extracts. For pur poses of the inventory, manufacturers should report as specifically as possible, using generic terms and & description of the method used m the final reaction sequence to produce `the reported substance. EPA will publish detailed instructions m 'Reporting tor the TSCA Inventory.'* Comment 87 Form D is an excellent idea which will be very useful for processors and others who buy trademarked chemicals who>e composition is unknown to them. It should be updated frequently. Response: EPA encourages manufacturers who report for the initial inventory to in:)udc on Form D the trademarks, whether registered or not. by which chemical sub stances reported for the inventory are known. A manufacturer may report a trade mark for a product which is a chemical -ubst a nee. a mixture or an article contain ing a chemical substance. As provided in the instructions to Form D. a manufacturer who chooses to report, must certify that all the chemical substances which comprise the trademarked product have been reported for the inventory, either by him or by someone else. - EPA recognizes that processors and users of chemical substances do not always know the identities of the substances they purchase and thus, may have difficulty determining whether or not the chemical substances they purchase are included on the inventory Processors could individually request sup pliers to certify that the substances they sell are included on the inventory. The Agency hopes to ease this burden somewhat by pro viding manufacturers who sell their products under a trademark an opportunity to certify that the chemical substances contained in the particular trademarked product have been reported for the Inventory. Any false certification would subject a manufacturer to criminal penalties under 16 U5.C. 1001. The usefulness of the trademark list is. however, limited. EPA recognizes that the composition of any particular trademark product may vary over time. Further, the Agency is not now requiring manufacturers who choose to report their trademarks to link the product name with specific chemical sub stances. Accordingly, the Agency will not be able to verify the accuracy of the trademark list. Because of the limited utility of the trade mark list, the Agency does not now intend to update it. The list ts designed to assist proc essors and users in reporting for the revised inventory. The Agency will be studying the continuing problem presented by the fact that persons in the chemical industry do not always know the identity of the substances they purchase. WHEN TO REPORT Comment 88: Manufacturers and processors need more than 90 days to report all the in formation required by these regulations. Response: The Administrator agrees with this comment, section 710.6(a) provides man ufacturers and importers until May 1. 1978 to report for the initial inventory. Section 710.6 lc) provides processors and users of chemical substances 210 days to report for the revised inventory The Agency encourages persons re porting for the inventory to stagger their submissions throughout the reporting period so that they can be processed in a timely manner. Comment 89 A manufacturer should be able to add new chemicals to the inventory any time prior to the start of premanufacture notification Response: The Administrator agrees with this comment. Section 710.8<b) provides this authority. A manufacturer or importer of a chemical substance in bulk may report a new chemical substance until 30 days after publi cation of the initial inventory. An importer of ?. chemical substance as part of a mixture or article may report a new chemical substance for the inventory until 30 days after publica tion of the revised inventory. Comment 90. Manufacturers and importers of chemical substances should be allowed to report for the revised inventory. Premanufac ture notification should not begin until after publication of the revised inventory. Response: The Administrator disagrees with this comment Postponement of pre manufacture notification until after publi cation of the revised inventory would delay the effectiveness of this provision of the Act for an unacceptable period of time. The re vised inventory may not be published unti* '"ovember 1979 or later. Comment 91 The Administrator should provide by regulation that failure to report for inclusion in the inventory for . "good cause * will not subject the manufacturer to the premanufacture notification require ments of section 5(a) (1) (A) Response: The Administrator disagrees with this comment. Such a provision is not appropriate for these Inventory reporting regulations. EPA does recognize, however, that given the large volume of Information that is to be compiled and transmitted, it is inevitable that there may be some clerical or technical errors made in reporting chemical substances for the inventory. Accordingly, the note at 710.1(b) of these regulations provides that as a matter of traditional Agency policy. EPA does not intend to con centrate its enforcement efforts on insig nificant clerical errors in reporting. Instead, EPA will give priority to bringing enforce ment actions against persons who (l) report false information. (2) report for Inclusion on the inventory chemical substances which are excluded under 710.4(0 of these regula tions, (3) fail to report, or (4) fall to main tain records documenting reported informa tion. Comment 92: In assessing any penalty on a manufacturer, the impacts on processors and users of the chemical substance(s) should be considered. Response: The Administrator agrees with this comment. Section 16(a)(2)(B) of the Act provides that in assessing any penalty the Administrator must take into account several factors. In assessing a civil penalty against a manufacturer, the Administrator as a matter of policy will consider the effect of the action on persons who process and use that chemical substance. CONFIDENTIAL. ITT Identity of Chemical Substance Comment 93: Some chemical identities are entitled to confidential treatment for pur poses of the TSCA Inventory. Any submitter should be allowed to claim that any chemi cal identity is confidential for the inventory. Response: The Administrator agrees with this comment. The general approach EPA will take to confidentiality of specific chemi cal identities for purposes of the inventory Is set out in the preamble and 710.7 of these regulations. In choosing this approach EPA had to balance the competing concerns of section 14 and sections 8(a) and 5(b). The reasons for taking this approach follow* The inventory is a list of chemical sub stances manufactured (Including imported) or processed for a commercial purpose. Many chemical substances have been developed and synthesized for which no commercial purpose has been found. The fact that some one has found a commercial purpose for a particular chemical substance may be a con fidential trade secret. Placement of the specific chemical Identity on the inventory would announce that fact to potential com petitors who-might be able to narrow their research activities. This problem would be further oompounded if the chemical sub stance were newly synthesized and known only to the person reporting it to EPA or if the substance were patentable. In which case Inclusion on the inventory might con stitute a publication and limit the person's patent rights. Were there no requirement in section 8(b) of TSCA to publish a list of chemical sub stances manufactured and processed for commercial purposes, there is no doubt that the fact that certain substances are manu factured or processed for commercial pur poses would be confidential under traditional trade secrets law and case law under the Freedom of Information Act fourth exemp tion (5 U.S-C. 552(b)(4)). Section 14(a) of TSCA states that any Information reported to EPA under TSCA that is exempt from disclosure under 5 U.S.C. 552(b) (4) may not F0ERAt RfGISTM. VOt 4?. NO. 247--FRIDAY. 0CMK# 23, 1977 RULES AND REGULATIONS 6-1591 be disclosed except in five situations speci fied In section 14 {ai and (b)- Standing alone section 14 would, accordingly, seem to require that EPA not disclose the fact that a particular chemical substance is manufac tured or processed for commercial purposes If that fact would be exempt from disclosure under 5 U.S.C. 552(b>(4). However, section 14 is part of a larger statutory scheme In TSCA. Section 8(b) requires EPA to publish a list of "each, chemical substance which Is manu factured or processed in the United States. Such list shall include each chemical sub stance which any person reports, under sec tion 5 or subsection (a) of this section, is manufactured or processed in the United States" (emphasis added). The Inventory is intended to Inform the public which chemi cal substances are being manufactured or processed in the United States for commer cial purposes. With this knowledge, the pub lic would know the chemical substances to which they may be exposed and would be able to take an active participatory role in EPA actions under .TSCA. This is clearly contemplated in sections 20 and 21 of TSCA that provide for citizens* civil actions and citizens' petitions. The inventory also has a regulatory purpose. It defines what is a "new chemical substance** for purposes of section 5(a)(1)(A). A "new chemical substance" is any substance that is not Included in the inventory. If a chemical substance is a new chemical substance no person may manu facture it without first submitting to EPA a 90-day premanufacture notice, during which time the person may not manufacture the new chemical substance. If EPA has promul gated a testing rule under section 4 of TSCA, the delay period before manufacture might be significantly extended. Were there no section 14 requirement in TSCA, EPA would publish a list of all chemi cal substances manufactured or processed In the United States for commercial pur poses without provision for claiming confiaentiality. The public would know all chem ical substances to which it may be exposed and would be able to participate fully un der sections 20 and 21 of TSCA. Any person proposing to manufacture a chemical sub stance would be able to look at the inven tory and determine whether the chemical substance was an existing chemical sub stance with a commercial purpose. If the substance appeared on the list, there would be no premanufacture notification require ments under section 5(a) (1) (A). If the sub stance did not appear on the list, the person would know it was a "new chemical sub stance." The Agency could conduct its In vestigation of all chemical substances in open public forums. However, were EPA to publish ail chemical substances reported to EPA on the inventory, some persons sub mitting the information would suffer com petitive harm when the fact that certain chemical substances have a commercial pur pose was published. Were EPA to give full effect to section 14 and publish a list of only those chemical substances for which the fact of manufac ture or processing for commercial purposes was not confidential, the public would have no information about those particular con fidential chemical substances to which it may be exposed. The Agency would have to conduct its investigation of some chemical substances in camera. A manufacturer pro posing to manufacture a chemical substance that did not appear -on the list would not know whether the substance was a new chemical substance. Therefore, the manu facturer would be forced to give premanu facture notification under section 5(a)(1) (A). If, in fact, the chemical substance had been reported for the inventory list, and, therefore, was not a new chemical substance, this new manufacturer would be placed at a competitive disadvantage by having to de lay manufacture at least 90 days. EPA has adopted the approach set out in 710.7 of these regulations to balance the concerns of section 14 wtth those of sections 8(b) and 5(a). In choosing this approach. EPA looked to TSCA for guidance. It is clear that Congress intended section 5(a) (1)(A) premanufacture notification to ap ply only to chemical substances which are not currently manufactured for a commer cial purpose. Congress created the section 8(b) inventory for the express purpose of determining this class of chemical substan ces. Congress did not seem to contemplate that the fact that certain chemical sub stances are manufactured or processed for commercial purposes would be claimed as confidential. Congress was clear In section 14 that confidentiality should be preserved to the maximum extent practicable without Impairing the regulatory scheme of TSCA. The approach EPA has adopted preserves confidentiality to the maximum extent prac ticable while allowing the section 8(b) In ventory to perform its regulatory function for purposes of section 5(a)(1)(A), preman ufacture notification. EPA will allow any manufacturer or proc essor submitting Information to EPA under this rule to claim that a particular chemical substance should not be Included on the inventory of chemical substances because the fact that the chemical substance is man ufactured or processed for commercial pur poses in the United States is a confidential trade secret. EPA will make a final confiden tiality determination in accordance with the procedures in 40 CFR Part 2, Subpart B. If the fact that a particular chemical sub stance is manufactured or processed for a commercial purpose in the United States is confidential, a generic chemical name will be Included in an appendix to the inventory; if it is not confidential, after 30 days notice to the submitter, the chemical identity will be included on the inventory. If any person re ports a particular identity and does not claim it as confidential EPA will place the identity on the inventory. Section 710.7(e) provides that a person claiming confidentiality for the specific chemical identity must provide a proposed generic chemical name to EPA. The proposed generic name must be only as generic as nec essary to protect the identity of the particular chemical substance. Pursuant to 710.7(f), EPA will review the proposed generic name. If the proposed generic name is not accept able to EPA. EPA will consult with the sub mitter concerning alternative names. EPA may choose a name proposed by the sub mitter or a name proposed by EPA. In the latter case. EPA will notify the submitter 30 days in advance of publishing the final choice, during which time the submitter may seek a Judicial remedy. Placement of the generic name in the ap pendix to the inventory will serve two pur poses. First, the public will know the generic types of confidential chemical substances to which it may be exposed. The public will be able to use this knowledge to participate m accordance with sections 20 and 21. Sec ond, a manufacturer who Is proposing to manufacture a substance not included on the inventory by name will be able to see whether the substance is described by one of the generic names. If It Is not, it is a "new chemical substance," and the manufacturer must submit notices under section 5(a)(1) (A) at least 90 days prior to manufacture. If the substance does fall within one of the generic names, the manufacturer could come to EPA. show a bona fide intent to manufac ture the substance, and be informed whether the specific proposed substance was included on the Inventory. If it was, the manufac turer would be able to begin manufacture without delay. If it was not, It would be a "new chemical substance," and the manu facturer would have to submit notice under section 5 at least 90 days prior to manufac ture. No person may manufacture a sub stance within a generic name unless EPA has notified the person that the particular sub* stance is Included In the inventory. To determine whether or not such a man ufacturer has a bona fide Intent to manufac ture the proposed chemical substance. EPA will require the manufacturer to submit a statement of present Intent to manufacture the particular chemical substance, Including a description of the research and development activities to date and the purpose of manu facture. In addition, EPA will require an ele mental analysis, either an X-ray diffraction pattern of the substance (for Inorganic sub stances) or a mass or alternative spectrum of the substance (for other substances), and any additional spectra pr data, including a sample of the substance In its purest form, that may be required to resolve uncertainties with respect to the Identity of the substance. At the time such an Inquiry Is received, EPA will contact the original submitter and ask for an elemental analysts and either a mass or alternative spectrum or an X-ray diffraction pattern of the substance. Further, additional spectra or data may be required to resolve un certainties with respect to the Identity of the substance. EPA may require a sample of the substance in its purest form for comparison with that submitted by the inquiring manu facturer. Section 710.7(e) provides that any person asserting a claim of confidentiality must agree to make such Information avail able to EPA upon request and must agree that EPA may disclose the fact that the specific chemical substance is Included on the Inven tory to a manufacturer with a bona fide in tent to manufacture the substance. (Failure to so agree or to furnish requested data re sults In waiver of the claim of confidenti ality.) If EPA determines that the manufacturer has a bona fide Intent to manufacture the substance, SPA will disclose whether the substance In question is on the Inventory. EPA scientists will compare the technical data submitted by the inquirer with that prepared by the manufacturer of the con fidential chemical substance to determine whether the data from both sources are suffi ciently similar to be consistent wtth a pre sumption that the chemical substances are the same. If EPA determines that the manu facturer has not shown a bona fide Intent to manufacture the substance, EPA will not dis close whether the substance is on the inven tory. The manufacturer will then have the choice of supplying further information to EPA to show bona fide Intent to manufacturer the substance or of submitting premanufac ture notification under section 5(a)41)(A). This approach will place some burden on manufacturers to come to EPA to show a bona fide Intent to manufacture. However, this burden is less than the burden of sec tion 5(a) (1) (A) premanufacture notification. Any manufacturer who does have a bona fide ii#ent to manufacture a particular substance should know the information required to show that Intent to EPA. This approach will discourage fishing expeditions by persons without a bona fide intent to manufacture and thereby protect trade secrets from dis closure to competitors. EPA does not view disclosure to a bona fide manufacturer to be a disclosure in violation of section 14. The trade secret that Is being kept confi dential Is that the particular chemical sub stance Is manufactured or processed for commercial purposes in the United States by anyone. If the inquiring manufacturer shows a bona fide Intent to manufacture the particular substance, the manufacturer ai- FEDERAl REGISTER, VOL. 42, NO. 247--.FRIDAY, DECEMBER 23, 1977 64592 . r-: s \ j: .. i * R011S AN0 REGULATIONS la v ready knows that tt can be manufactured for a commercial purpose. Telling the man ufacturer that the substance is on the in ventor)* does not reveal anything except that someone else already found a commercial purpose for the substance. Maintaining specific chemical identities as confidential for purposes of the inventory has impacts beyond those on sections 8(b) and 5ia>. It is conceivable that the Agency ties reported 'or the inventory. Accordingly, companies should be very careful In claim ing that specific identities are entitled to confidential treatment. Comment 96: EPA should accept the ge- the generic chemical name is too broad or misleading, request the submitter to modify the generic name. EPA should not substitute its judgment. EPA should not substitute its judgment for that of the submitter. Response: EPA .s rcr.s.dering alternative ways of publishing aggregates of production and other data submitted for chemical sub stances. However, before EPA publishes any aggregation that includes data that have been claimed as confidential. EPA will develop aggregation procedures designed to protect the confidentiality of the underlying data and will publish these procedures for public comment. will decide to direct a section 4 testing rule ro a confidential chemical, that the Agency will decide to promulgate a section 5ia){2i Significant new use rule on a confidential chemical, that the Agency will decide to pro mulgate a section 8 reporting rule on a con fidential chemical, and that proceedings un der section 20 and 21 of the Act may pertain to confidential chemicals. The Agency intends to honor the confidentiality of specific chem ical identities to the extent practicable with out impairing the Agency's ability to perform its duties under TSCA. This means that EPA may have to balance confidentiality with other TSCA needs at future times under other rules TSCA section 14 {&) and ib> directs the Administrator to disclose information otherwise entitled to confidential treatment in certain circumstances. The Agency intends to rely on these authorities to the fullest ex tent provided by law. A determination that an identity is con-, fidentiai for purposes of the inventory may be reviewed if new facts suggest that confiden tial treatment is no longer appropriate. Com*n?nf 94: Requiring substantiation at the time of submission of a claim that the identity of a chemical substance should no: Response: The Administrator disagrees with this comment. Submitters will have an interest in submitting the broadest generic names possible. Since EPA Is balancing com peting considerations of confidentiality, the public's right to know, and the interests of manufacturers under section 5(al. EPA must take an active role In choosing a generic name that is only generic enough to protect the trade secret Identity. li EPA agrees with the generic chemical name proposed by the submitter and the chemical identity has been found to be con fidential for purposes of the inventory. EPA will place the proposed generic name In an appendix to the inventory. If EPA* believes that the generic name is too general so that it will not serve the purpose of Informing the public ar.d future manufacturers under section Sia), EPA will consult with the sub mitter concerning more restrictive names. If EPA and Che submitter are unable to agree on the generic name. EPA will choose a generic name, notify the submitter of the choice at least 30 days before Inclusion on the inven tory. Jhe submitter" may seek a judicial remedy under section 14. Unless a court In tervenes. after the end of the notice period. EPA will place the generic name on the list. National Security information Comment 100: Some information required bjr these regulations may be entitled to con fidential treatment because of national se curity reasons. How will EPA handle asser tions of confidentiality on these grounds? Response: Section 22 of TSCA states that EPA "shall waive compliance with any pro vision of this Act upon a request and deter mination by the President that the requested waiver is necessary in the interest of na tional defense." The President has not re quested that any waiver be granted with re gard to the inventory regulations. Accord ingly. any person subject to the reporting re quirements of these regulations must report any substance subject to these regulations even If that substance is being made for national defense purposes. Production foe national defense purposes is a commercial purpose as defined in .these regulations. Any person reporting under these regulations must report all information required to be reported concerning sites, production, etc regardless of whether that information re lates to national defense If a person required to report under these regulations would be reporting information be placed on the inventory is overly burden some Such substantiation should only be re quired when necessary to respond to a Free dom of Information Act request. Response: The Administrator disagrees with this comment. The requirement ut TSCA section 8(b) that the Agency publish an inventory of chemical substances re quires the Agency to make individual Scat determinations on the entitlement of the identity of a particular chemical substance to confidential treatment under the test of 5 U.S.C. So2;b> <4) before publication of the initial inventory. Under the procedures of 40 CFR Part 2. Subpart B, this determina tion is made on the basis of the substantia tion of that claim provided by the person asserting the claim. In order for EPA to re view, prior to publication of the initial in ventory. all claims that the identity of a chemical substance is entitled to trade se cret protection, substantiation of the claim mast be submitted when the claim is as serted Failure to submit substantiation of such a claim will be a waiver of the claim. Comment 95 The statements for sub stantiating a claim for confidentiality on proposed Form C are too restrictive. A com pany must be allowed to state for itself the Link of Company Name to Chemical Identity Comment 97: The fact that a certain com pany manufactures a particular chemical substance may be a confidential trade secret. EPA should not publish company names on the inventory. Response: The Administrator agrees with this comment. Section 7107(a) permits a manufacturer, importer, or processor to claim that the link between the name of the manutacture. importer, or processor with a parti cular chemical substance Is entitled to con fidential treatment The 8(b) Inventory will consist only of a list of chemical substances reported to EPA. It will not Include any in formation concerning which companies re ported the chemical substances. A claim that a particular chemical Identity should not appear on the Inventory (see comment 92) should not be made 1/ the only confidential trade secret Is the link between the com pany name and chemical Identity. If a claim of confidentiality Is asserted re garding the link of company name with a particular chemical substance. It will be dis closed by EPA only to the extent permitted by. and by means of the procedures set forth m 40 CPR Part 2, Subpart B. that is or may be classified as national de fense information under Executive Order 11652. that person should not report to CAS. Instead, the person must contact Kenneth Olsen. Office of Toxic Substances. EPA. 40 L M Street, SW.. Washington, D.C. 20460. by letter stating that the person may be reouired to report classified information to EPA under these regulations. Do not report the classified information to EPA at that time. EPA will send the per son a letter with specific instructions how to proceed. This will include forwarding the information to the particular systems pro* gram office that is managing the particular work involved. The systems program office will examine the specific information and mark it with the appropriate classification. The information will then be sent to EPA where it will be kept in & special system seD&rate from the remainder of the inventory information. EPA will have an office with personnel authorized to receive and use clas sified information. Please note, if the information in question is also considered to be confidential business information by the person submitting it, that person must assert all claims of business con fidentiality at the time the information is basis of its claim of confidentiality, Response- The Administrator agrees with this comment Any submitter claiming that Production data Comment 98: Site specific production data may be a confidential trade secret. submitted to EPA in accordance with these regulations and the instructions on the forms. the identity of a particular chemical sub Response: Section 710.7(a) recognizes that Freedom of Information Bequests stance snould not be included on the lf ventory must suostantiate that claim. The substantiation must be in the form of a let ter attached to Form C stating the submit ter's basis for its claim of confidentiality and addressing a list of questions specified in the Form C Instructions. The burden for sub stantiating a claim that the particular chemical identity should not appear in the Inventory is greater than that for substanti ating other confidentiality claims under the inventory because of the increased burden that will be placed on the public and future manufacturers under section 5fa) in not knowing all of the specific chemical identl- production data may be entitled to con fidential treatment and permits persons re porting production volumes to the Agency to assert a claim of confidentiality. Section 710 5(d)(4) of these final regulations re quires companies to report broad production ranges, rather than the more specific produc tion volumes which would have been required by the August 2, 1977 proposed rules. This should eliminate the need for many claims of confidentiality. Comment 99: Does EPA plan to publish aggregates of data from the inventory, espe cially confidential data? If so. In what way will EPA protect the confidential data? Comment 101: How will EPA handle Free dom of Information Act requests for the confidential information submitted under these regulations? Response: EPA w\U allow submitters to claim any item of Information submitted to EPA under this rule as confidential. The re porting forms are designed to allow all con fidentiality claims to be made by checking boxes on the forms. In addition, the certi fication statement has been written to allow a submitter to substantiate all claims of confidentiality, except chemical identity, on the reporting form. By using this approach, EPA intends to minimize the need to go back FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS 64593 to specific submitters to require them to sub. stantiate confidentiality claims. This will en able EPA to deal more eflectlvely with the anticipated large volume of Freedom of In formation Act requests that will be received under TSCA. -- " All Information submitted under these rules will be computerized. All confidential Information (except confidential identities) will be specially coded If a claim of con fidentiality was made and substantiated at the time of submission. When EPA-receives FOIA requests, EPA will prepare a computer print out of the non- confidentlal information requested: that In formation will be disclosed to the requester. The computer will then print out the re quested confidential information. The re quester will receive an initial denial of the request for any confidential Information In accordance with the procedures In 40 CFR Part 2, Subpart B. EPA will then make a final confidentiality determination, Inform the requester of the decision, give 30 days notice to the submitter if the determination is that the Information Is not entitled to confidential treatment, and then disclose any non-confidential Information. EPA will not have computer access capa bility until at least 6 to 8 months after the end of the initial reporting period. During that period the Agency will be processing submitted Information. The actual forms submitted to EPA will not be filed m a re trievable form. If EPA receives POIA requests prior to the end of the processing period it will be virtually impossible to search for the requested information. Consequently, EPA requests that FOIA requesters retrain from making FOIA requests for inventory Informa tion until the end of the processing period. In some cases, when responding to FOIA requests, EPA will be forced to give unin formative denials. If a requester asks a ques tion in such a way that to answer the request would reveal confidential information, EPA will answer the request In the following fashion: "Your request Is denied either be cause the records you request are entitled to confidential treatment under S U.8.C. 552(b) i4) and EPA may not disclose them under section 14 of TSCA. or because no such rec ords exist." The requester will have a final EPA denial and will be able to go to a Fed eral district court to seek further review. The confidential information will be protected, pending this review. Confidentiality Procedures and Security Comment 102: How will EPA determine the entitlement of information to confiden tial treatment; what procedures will it follow to ensure that confidential information Is not disclosed? Response: The Agency's business confi dentiality regulations are contained at 40 CFR Part 2. Subpart B. These regulations will be amended to take into account specific modifications required by TSCA section 14, such as the extension of the notice period to 30 days. The basic approach for determining confidentiality will not change. EPA has established a Task Force to rec ommend procedures to the Administrator to provide for the security of confidential In formation submitted to EPA under TSCA. The Task Force will work quickly so that EPA will have procedures adopted by April 30, 1978, the end of the Inventory reporting pe riod. The Task Force will hold several public meetings and will publish proposals for publice comment. The final security procedures will be published. A more detailed discussion of the work of the Task Force appeared in the Fedzbai. Register. 42 FR 57984, Novem ber 7.1877. ........ Access to Confidential Injormation by States Ccmment l03EPA should allow access to confidential-information by the states. Response: EPA does not have general au thority to disclose confidential TSCA Infor mation to the States. Section 14(a) lists the parties to whom confidential Informa tion may be disclosed. In certain circum stances, EPA may disclose confidential In IMPORTANT! formation to other Federal agencies, to TSCA contractors, when relevant to a proceeding under TSCA, or when necessary to protect health or the environment against an un reasonable risk of Injury. Accordingly, con fidential information may only be disclosed' to a State If the State Is an EPA contractor. If the State is a party to a TSCA proceeding, of when necessary to protect health or the environment from an unreasonable risk of Injury. FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMRER 23, 1*77 64594 RULES AND REGULATIONS IMPORTANT: U. S. ENVIRONMENTS PROTECTION AGENCY CHCMICM SUttSTANCt INVENTORY REPORT (SmNw ) mid |b) Tirit Tub--win Cmtmi tm IS USC 2*071 l cfrtvCATKX tr*rMCMr-1 iSl'xMU B . Pl>Nt Sill NAM</A00*CSS -"L Tirco*^o**ro* IV.">*NCAl TtCMNlCAt CONTACT,'SI C0g*r"L .summi Vi MSI OMIT J RUMTSffl i CCVOl4ro< K* **COHoCI TON ^ SUE IMAUfO qf MR*oar ^ AUMU<T4CTUM SiTf LIMITED MMotr Z <MMVcTviai nooAuMcCn4oN MM * M40STWT NO. - #* *| < K m __ f ss V if, gM A IA/ osr r~] ! [0C 5r |i i o *S3 22 l w00z -<u i<* il u, * uyIM z% #ii uMB *rt -5* 33 ! ii 11 2> sz ^1 Si ! sz 1 uI NUMB!* , - N r <n IRtUCORT 1 IS i : o> o L. FEDERAL REGISTER, VOi. 42, NO. 247--FRIDAY, DECEMBER 23, 1977 RULES AND REGULATIONS IMPORT AMT: U. &. ENVItONMBffAL PROTECTION AGOKY CHIMICAl SUftSTANCS IMVfNTORT IIPORT IW Tm ........ CmmmI A* IS USC1407) L CUTVCtfCN SlA7MMt< I *T ijw* jjriMk* miiTTliw CTt a M Mr *MM iwaMM4 aTtfA MwMMW. MrtM "TSSOTSTfiSPSSSP" 1M. PtANT SfTf NAMC/AOOMii 1 IV. NKIM TiCHNCM CONTACT(S) w*cnim A4AML#ACTUM 3! r5 I *1 1 fl J 22 II lin j ur- m o&*eiii- *3 3J 33 u3 1U * i2 U il* jz s Z'Otu o'-y s| iiHf, is|llsillifl 2*1 3 y Su_ sssma it* 22""2z **5 Sou Sa* S|z |<s Sau w o r: ala** fas Sgg *< 64595 FEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 64596 RULES AND REGULATIONS IMPORTANT: U. S. ENVIRONMENTAL PROTECTION AGENCY VOLUNTARY PRODUCT TRADEMARK REPORT 40441 D L CZRTfCAnOH STAflMiNT. 1 Ml--1 --MeE. W EM * V M--EEtf ME. EMM EMmEUM k> -- bMErr DPR---- nM-- IPMNWAB ME NEEREMMrtrM * -- --** 1 ^MD *M E Im Memr CmE i 1 ! ! S 1 i> Ji. CdtfOftAteNAMt/AtfftUS-------------------------------------------------------------- L MMCALTCCHPilCALCONTACT(S) cn. 1...................................................................................1 U UMIWHO, IV. LIST Of 44QOUCT TRaOEMARKS * PftOOUCT TRACEMARKS (NAMES) 1 *of 1 L It j h 30 PROOUCT TRADEMARKS (NAMES) 3 3 K 3! 4 4 L 33 s p 33 * it 7 All lr fs > 34 10 ioK 31 11 m 34 13 13 40 Y3 13 41 M 14 43 ts IS ' 43 14 14 ^ 44 17 17 ' 43 If It s 44 14 it' 47 30 30* 44 31 31 J 4 33 33 ' 90 33 33 51 34 34 S3 3$ 33 53 34 34 ' 54 37 7t rr**.j* i ii./T) 37 v 95 21 ' 94 IFR Doc.77-36420 Filed 12-19-77:9:41 ami 34 30 31 22 33 u 35 34 37 34 34 40 41 43 43 44 41 44 47 44 44 so SI S3 S3 94 SS S4 FEDERAL REGISTER, VOL. 42, NO. 247---FRIDAY, DECEMBER 23, 1977 GPO 043 * 944 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 INDUSTRY ASSISTANCE OFFICE OFFICE OF TOXIC SUBSTANCES The purpose of this letter is to alert you to the importance of the material contained in this packet and the need to read the material carefully. If you are a manufacturer or importer of chemical sub stances, this packet is of special importance, because it includes the Toxic Substances Control Act (TSCA) inventory reporting forms (A,B,C,D), an instruction manual on reporting and instructions on obtaining additional forms (see the page in this packet headed "Forms, Forms, Forms"). Although under TSCA, action is required, at this time, only by manufacturers and importers of chemical substances, other recipients should find the packet educational. Now check your packet. It should include the following: 1. The FEDERAL REGISTER containing the final TSCA Inventory Reporting Regulations and Significant Comments and Responses. 2. Questions and Answers about inventory reporting. 3. Information on how to get more Forms (with a postal card for your convenience). 4.* One set of Inventory Reporting Forms (A,B,C,D). 5.* Instruction manual on reporting. * not included in all packets If, after carefully reading this packet, you have ques tions about inventory reporting, call us (800-424-9065). Sincerely yours : U.S. Government Printing Office - 1977 -781-982/193 FORMS, FORMS, FORMS NEED INVENTORY REPORTING FORMS? HERE ARE FOUR FAST WAYS OF GETTING THEM: 1. FILL OUT AND MAIL THE SPECIALLY PRINTED POSTAL CARD THAT YOU WILL FIND IN THIS PACKAGE. 2. CALL THIS TOLL-FREE NUMBER (600424-9065) AND TELL US WHICH FORMS AND HOW MANY YOU NEED. IF CALLING FROM WASHINGTON,D.C.: 554-1404 3. CALL OR VISIT YOUR REGIONAL OFRCE OF TOXIC SUBSTANCES (OTS) OFFICE (SEE THE BOX BELOW). 4. WRITE AND TELL US AT OTS HEADQUARTERS WHICH FORMS AND HOW MANY YOU NEED. (IND. ASST. OFRCE, OFRCE OF TOXIC SUBSTANCES, TS-799, USEPA, WASHINGTON, D.C. 20460. REGION I Mr. Robert Dangel* John F. Kennedy Federal Building Boston, Massachusetts 02203 617 - 223-0585 REGION II Mr. William Librizzi* Raritan Depot, Building 209 Edison, New Jersey 08817 201 - 321-6673 REGION III Mr. Edward Cohen* Curtis Building 6th & Walnut Streets Philadelphia, PA 19106 215 - 597-7668 REGION IV Mr. Ralph W. Jennings, Rm. 345 Toxic Substances Section Chief Air & Hazardous Materials Div. 345 Courtland Street, N.E. Atlanta, Georgia 30308 404 - 881-3864 REGION V Mr. Karl E. Bremer* 230 South Dearborn Street Chicago, Illinois 60604 312 - 353-2291' REGION VI Dr. Larry Thomas Assistant TSCA Coordinator First International Building 1201 Elm Street Dallas, Texas 75270 214 - 767-2734 REGION VII Dr. Maxwell Wilcomb* 1735 Baltimore Avenue Kansas City, Missouri 816 - 374-3036 64108 REGION VIII Mr. Ralph Larsen* 1860 Lincoln Street Denver, Colorado 80295 303 - 837-3926 Mr. Jerry Gavin*, Rm. 215 215 Fremont Street San Francisco, California 415 - 556-3352 94105 REGION X Dr. James Evert* 1200 6th Avenue Seattle, Washington 206 - 442-1090 98101 Toxic Substances Coordinator Feb. 28-Mar. 17 U.S. EPA Toxic Substances Control Act Seminars on TSCA Inventory 9:30-1 2-3:30 YOUR REPORTING REQUIREMENTS^ SMALL-GROUPS YOUR TOPICS REPORTABLE & EXCLUDED X INDIVIDUAL CONSULTATIONS SUBSTANCES LEARN-BY-DOING I TRADE ASS'N REPS AVAILABLE LOTS OF YOUR Q&A Telephone to Pre-Register! U.S. CHAMBER OF COMMERCE REGIONAL COMMUNICATIONS # BELOW NORTHEASTERN AREA: 212-557-9898 SOUTH CENTRAL AREA: 274-387-0404 2/28 BOSTON Boston-Waltham Holiday Inn, 466 Totten Pond Rd. off Rte. 128, exit 48E. 3/1 NEW YORK New Yorfc-Coliseum Holiday Inn, 440 W. 57th St., mid-Manhattan between 9th and 10th Avea. ' 3/2 ALBANY Albany-Airport-latham Holiday Inn, U.S. 9. exit 24 from NYS Thmway. 3/3 ROCHESTER Rochester-Airport Holiday Inn, 911 Brooks Ave., off 1-490, exit 47. 3/7-8 NEWARK Newark-International Airport Holiday Inn, 160 Holiday Plaza, exit 14 from NJ Tpk. 3/9 PHILADELPHIA Philadelphia-City Line Holiday Inn, Rte. 1 and 1-76 City Ave. exit or north from Amtrak 30th St. Sta. 3/10 HARRISBURG Holiday Inn Town. 2nd and Chestnut Sts.. 2nd St. exit from 1-83. NORTH C::.\ ' / AREA: TO? 386-4830 3/14 PITTSBURGH 3/15 CLEVELAND 3/16 CINCINNATI 3/17 INOIANAPOLIS 2/28 CHICAGO 3/1 3/2 DETROIT 3/3 MINNEAPOLIS Pitts.-Allegheny VaUey Holiday Inn, 180 Gamma Dr. at R.I.O.C. Park, Allegheny Expwy, oft 1-80 and 1-76. Cleveland-Independence Holiday Inn. 6001 W. Rockside Rd., exit off 1-77. Cincinnati-Riverfront Holiday Inn. 600 W. 3rd St., Covington, on 1-75 at 5th St. exit. Ind.-Speedway-N.W. Holiday Inn. 6330 Debonair La.. Jet. 1-465. 1-74 and U.S. 136. Chicago-O'Hare Airport Holiday Inn, 3801 N. Mannheim Rd.. Jet. 1-294, U.S. 45 and Rte. 19. Detroit-Farmington Hills Holiday Inn, 38123 W. 10 Mile Rd. at 1-96 and Grand River Ave.. off 1-275. St. Paul-State Capitol Holiday Inn. 161 St. Anthony St., opp. State Capitol. Marion St. exit from 1-94. 3/2 DALLAS O/FW Airport-N. Highriae Hotky Inn. Rte. 114 at Eaten R,, north entrance to O/FW Airport off 1-636. 3/7 KANSAS errv Kara** CttyOty Cantor Holiday Inn, 1301 Wyandotte St.. Jet. 1-70. U.S. 71 & Alt. 00. 3/8 ST. LOUIS St. Lout*-Worth Holiday Inn, 4646 N. Undbargh Blvd.. on U.S. 140 at 1-70, 3 mi. E. of 1-270. 1 3/9 10 HOUSTON Houston-NASA Holiday Inn, 1300 NASA Blvd.. on Rte. 528 off 1-46 (NASA exit! or Rta. 148. | 3/11 BATON ROUGE Baton-Rouge-South Holiday bin, 9940 Airline St., Jet. U.S. 61 and 1-12. SOUTHEASTERN AREA: 404-393 0140 3/3 ORLANDO Orlando-Artamonte Springe Holiday Inn 1-4 and Rte. 438* . 3/14 ATLANTA Atlanta-Airport Holiday Inn, 1380 Virginia Ave., off 1-86 S. 3/19 NASHVILLE NashviBa-Vandarbi* HaMd.Jnn. 3613 Wast End Ava.. on U.& TOS^r oft 1-40 at Broadway (MB) exit. 3/16 WINSTON-SALEM Wm.-Sel. Coliseum (North) Holiday Inrd N. Cherry-Marshal Expressway. _ | WESTERN AREA: 408-275 8110 2/28 LOS ANGELES 3/1 3/7 LOS ANGELES 3/8 SAN JOSE 3/9 OAKLAND 3/10 PORTLAND Buena Park (Disneyland) Holiday Inn, 7000 Beach Blvd.. Beach Blvd. axit from Santa Ana or Riverside Frwy. Laguna Hills Holiday Inn, 25205 La Paz Rd.. Jet. 1-5 and 1-405 south of Orange Co. airport. San J.-Park Center Plaza Holiday Inn, 282 Almaden Blvd. at W. San Carlos Ave. Marriott Motor Inn-Berkeley, on Rte. 17 and 1-80 at University Ave. exit. CosmopNitan Airtel., 6221 N.E. 82nd Ave.. off Columbia Blvd. and 80th Ave. TS-799 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20*60 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. 1300 POSTAGE AND PEES PAID U.S. ENVIRONMENTAL PROTECTION AGENCY EPA-33S U.S. Environmental Protection Agency Director, Industry Assistance Office Office of Toxic Substances (TS-799) Washington, DC 20460 My firm needs the followi hg Toxic Substances Control inventory reporting forms in the indicated quantities. FORM A FORM B QUANTITY QUANTITY form C "QUA~NTrTY " FORM D QUANTITY ~" Firm Name: Street Address: State & Zip Code: ATTENTION: Signature: Q7] Please check here if you did not receive but would like to have a copy of the Candidate List. I