Document nmeRqQ1wLomma29BY0M9qRJbw

Friday July 11, 1980 PLAINTIFF'S EXHIBIT KM-384 Part III Environmental Protection Agency Toxic Substances Control; Records and Reports of Allegations of Significant Adverse Reactions to Health or the Environment KMX 01177 47008 Federal Register / Vol. 45. No. 135 / Friday, July 11. 1980 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40CFR Part 717 [FRL 1483-4] Toxic Substances Control Act; Records and Reports of Allegations of Significant Adverse Reactions to Health or the Environment AGENCY: Environmental Protection Agency. action: Proposed rule. * summary: Section 0(c) of the Toxic Substances Control Act requires that "any person who manufactures, processes, or distributes in commerce any chemical substance or mixture" must keep "records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture." Section 8(c) requires that employee allegations be kept for 30 years, and all other allegations be kept for five years. This proposal sets out definitions and procedures for implementing section 8(c). Note.--Persons who "process" chemical substances or mixtures include companies that manufacture consumer goods or industrial products. Manufacturers of automobiles, paper products, textiles, or electronic components, for example, should consider commenting on this proposed rule. OATES: In order for EPA to consider comments during development of the final rule, it must receive written comments on this proposal on or before October 9,1980 (see Public Meetings below for a discussion of meeting arrangements.) address: Written comments should bear the document control number OTS083001 and should be submitted to the Chemical Information Division, Office of Pesticides and Toxic Substances (TS793), Attention: Document Control Officer. Environmental Protection Agency, Washington, DC 20460. All written comments concerning this notice will be available for public inspection at the OPTS Reading Room. 447 East Tower, from 9:00 a.m. to 5:00 p.m.. Monday through Friday. FOR FURTHER INFORMATION CONTACT: John B. Ritch, Director. Industry Assistance Office, Office of Pesticides and Toxic Substances (TS-799), Environmental Protection Agency, 401 M Street. SW. Washington. DC 20460, 800 424-9065; in Washington call 554-1404. SUPPLEMENTARY INFORMATION: This proposed rule to implement section 8(c) of the Toxic Substances Control Act. 15 U.S.C. 2607(c), would apply to all persons who manufacture or process chemical substances or mixtures, and to all distributors except retailers. These persons would be required to keep records of allegations of "significant" adverse reactions. These are defined as reactions that suggest that a chemical may cause long-lasting or irreversible damage to health or the environment. In the proposal, records of written and oral allegations that are not anonymous and that implicate a chemical substance or mixture would have to be kept at the plant site where they are received. For reporting purposes, companies would have to transfer data from allegation records to a standard EPA form. The proposal discusses options for automatic reporting of certain allegations to EPA. The proposal also contains a provision under which EPA will require firms to submit records at the specific request of EPA. EPA has worked closely with the Occupational Safety and Health Administration and the Consumer Product Safety Commission during the development of this proposal. The Agencies intend to share information about workers and consumers that results from this requirement. Purpose and Scope Section 8(c) of the Toxic Substances Control Act requires that persons who manufacture, process, or distribute chemical substances or mixtures record allegations of significant adverse reactions to such chemical substances or mixtures. The section also requires that such records be submitted upon the request of the Administrator or his duly designated representatives. This proposed rule implements these requirements. The rule proposes a system of recordkeeping and reporting which would serve the following purposes: (a) It would establish an invaluable historical record of allegations of significant adverse reactions and related information which EPA can examine whenever a chemical is discovered to present possible risks to human health or the environment; and . (b) It would provide a means to reveal patterns of adverse effects which might otherwise either not be noticed or go undetected for long periods of time, and to identify previously unknown chemical hazards. Definitions Section 8(c) does not make recordkeeping contingent upon evaluating or verifying an allegation. In the proposed rule, the Agency has defined an allegation in part as a "statement made without formal proof or regard for evidence." This lack of need for supporting information is one factor that distinguishes section 8(c) from section 8(e) of TSCA (substantial risk notification). Section 8(e) states that persons must immediately inform the Administrator if they have information that reasonably supports the conclusion that a chemical substance poses a substantial risk of injury to health or the environment. A report of substantial risk of injury, unlike an allegation of a significant adverse reaction, is accompanied by information which reasonably supports the seriousness of the effect or the probability -of its occurrence (see 43 FR 11110 etseq., March 16,1978). However, the Agency recognizes that an allegation (or allegations) recorded under section 6(c) could result in a notification of substantial risk filed under section 8(e) if a firm obtains additional information that meets the higher standards of section 8(e). If this happens, and a firm files a section 8(e) report, the Agency would not require the firm to separately' report to the Agency under section 8(c) (see discussion under Reporting Requirements). However, the opposite is not true: complying with section 8(c) requirements does not relieve a firm of any responsibilities under section 8(e). For the purposes of this rule only, "significant adverse reactions to health or the environment" are those which indicate the possibility of long-lasting or irreversible damage to health or the environment. We have included descriptions of effects to illustrate what we mean by "significant." Specifically, we intend to exclude one-time effects, such as those resulting from an accidental poisoning or an accidental spill of a caustic chemical onto the skin. This exclusion is proposed because we believe that recordkeeping under section 8(c) is important for health effects whose implications may not be fully apparent at the time of their occurrence. In addition, the Occupational Safety and Health Administration recordkeeping requirements for work-related injuries and illnesses cover serious effects of the kind that we propose to exclude (see 29 CFR Part 104). This proposed rule does not attempt to enumerate all of the specific effects and circumstances which may constitute a significant adverse reaction. Rather, we have measured significance in terms of when the adverse reaction occurs in relation to exposure to a substance, and how long the effects last. Health effects that last only for the duration of the exposure should be recorded only if they occur repeatedly. This means that Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules 47009 nausea or headaches may be significant limited since they handle packaged adverse effects if they are experienced products. In addition, it appears that repeatedly by a person upon exposure to allegations from employers or the substance. Effects that persist consumers regarding brand name beyond the period of exposure (such as products are, as a general practice, sent kidney dysfunction or sterility) are by retailers to the manufacturer or reactions that should be recorded, even processor, because it is in the retailers' if alleged only once. We have broadly defined adverse interest to report to their suppliers any customer problems resulting from the environmental reactions that should be use of products (see item 2 of the record recorded. Generally, adverse described at the end of this preamble). environmental effects may be indicated The supplier will be a manufacturer, by gradual or sudden changes in the processor, or distributor who is subject composition of plant or animal life in an to this rule. Hence, manufacturers', area. Such adverse changes in the processors', and distributors' records . composition of life could be indicated by would be generally more abnormal numbers of animal or plant comprehensive, and should be sufficient deaths; a decline in the vigor or for the purposes of this rule. In addition, reproductive success of a species; a retailers are so numerous and include so reduction in either crop or livestock many small firms that we will consider agricultural productivity; or alterations including them in this rule only if it in the behavior of a species. The Agency requests comments on the appropriateness of these proposed criteria. Also, we invite persons wishing clarification of what constitutes a recordable allegation to include in their comments either real or hypothetical examples for interpretation. In the preamble to the final rule, we will address typical examples submitted in response to this proposal and use them to clarify the definition. appears that exempting them will substantially reduce the effectiveness of this rule. The Agency solicits comments on whether retailers or other small businesses should be exempt from the requirements of this rule. If the comments make it clear that including retailers will make the rule substantially more effective and the greater effectiveness is justified when weighed against the burden that would be imposed, then retailers will be included Persons Subject to This Part in the rule as promulgated. This proposal would apply to all Allegations Which Must Be Kept persons who manufacture or process chemical substances or mixtures, and to all distributors of chemical substances and mixtures except retailers. The term "manufacture" is defined in TSCA to include manufacture, import and production. The term "process" is defined in TSCA to mean preparation of a chemical substance or mixture for distribution in commerce (a) in the same or different form or physical state from that in which it was received, or (b) as part of an article. Thus, persons who ordinarily consider themselves to be "users" because all that they do is incorporate a chemical into an article, are "processors" under TSCA. Retailers are firms that sell a final product to ultimate purchasers who are not commercial entities. The definitions of "manufacture for commercial purposes" and "process for commercial purposes" are discussed in greater detail in the preamble of the proposed TSCA section 8(d) rule "Health and Safety Data Reporting", published December 31, 1979, in the Federal Register (44 FR 77470). Retail distributors are the only small businesses that the Agency proposes to exempt from the present rule. Retailers are excluded because the potential for retail employees being exposed is The proposed rule would require companies to keep records of written and oral allegations so long as the allegations are not anonymous, and so long as they are made to an appropriate company official, e.g^ a supervisor, a company physician or health unit staff member, a company agent, or a public relations officer. The Agency believes that oral allegations should be written down, since many people are more likely to submit allegations by telephone than in writing. This proposed rule does not limit the recording of allegations to those which describe a chemical substance by exact name. The Agency believes that requiring an exact name would be too restrictive because there will be instances when employees, plant neighbors, or consumers (or the firm itself) will not be able to name a specific chemical--either because their knowledge of chemistry is limited or because they have encountered more than one chemical and cannot pinpoint only one chemical as the cause. The/ proposed rule requires firms to keep not only allegations that name a specific chemical substance, but also those that reasonably implicate a chemical. . Therefore, the proposed rule states that firms must also keep allegations that name or identify the following; an article which contains a specific chemical substance or mixture; a company process or operation that involves one or more chemical substances; or an effluent emission, or other chemical discharge from the site of manufacturing, processing, or distribution. Recordkeeping Requirements As mentioned earlier, a major purpose of this rule is to establish a complete record for both the EPA and industry, so that a body of knowledge will exist for reference should concern arise over a particular chemical. The record can provide another means for industry to monitor the safe production and use of chemical substances and mixtures. In addition. EPA could request the submission of allegations that involve a chemical which is being investigated After analysis, those allegations could then be used during the assessment process to supplement already known toxicity and exposure data on the chemical substance. A further purpose of the records could be to provide a means during inspections to help determine whether a chemical problem exists at a plant site. This proposal would require firms to keep copies of original allegations and to establish records that contain specified information about the allegations. A standard EPA farm is offered as an optional recordkeeping form. The same form would be - mandatory for reporting purposes. It is important that EPA receive die reports in a standard format so that they can be processed and evaluated efficiently. On the other hand, the form would be optional for recordkeeping since the Agency recognizes that firms may have already developed other forms or automated systems of recordkeeping which may not be compatible with the proposed EPA form. The proposed rule specifies the information that must be kept if the EPA form is not used. The Agency solicits comments concerning the appropriateness and usefulness of the information on the form. The form appears as Appendix 1 to the proposed rule. This rule would also require firms to file allegation records and forms in a specified way so that this information could be easily retrieved. Allegation records and forms would be filed by chemical substance if the substance is known. However, for cases in which it is not possible to identify a specific chemical as the cause of a problem, firms would establish files according to mixture identity, and. if this cannot be determined, by the identity of the 47010 Federal Register / Vol. 45. No. 135 / Friday, July 11. 1980 / Proposed Rules article, company process or operation, or plant site discharge involved. The rule would require that the results of any follow-up investigation be kept with the allegation records and the corresponding EPA form or company form or file. This is important to a basic purpose of the rule, which is to establish a complete historical record. Such a record should include information that the firm recorded on its own. and information that was recorded because of requirements set by another agency, such as the Occupational Safety and Health Administration (OSHA). A firm must keep allegation records, recordkeeping forms, and the results of any follow-up investigations at the site where the allegation is received. The Agency believes that it is logical to keep a complete record at the site where the problem occurs, for reference purposes. In connection with the proposed automatic reporting requirement, plant sites must also send copies of the EPA standard form or company form to be aggregrated and reported by the company headquarters, if this differs from the site where the allegations were received. . We have included an alternative method of compliance for distributors. This would permit a distributor to send allegations to the appropriate manufacturer or processor instead of keeping them as records. The distributor would be required to send an allegation within five days of its receipt, and to keep a log (thirty years for employee allegations, five years for others) showing the name and address of the person to whom the allegation was sent, the date it was sent and a brief description of the chemical that is the subject of the allegation. This would greatly reduce the recordkeeping requirement for distributors, while adding only a minimal burden to the manufacturers and processors who would have already established procedures for recordkeeping and reporting allegations. Furthermore, this provision would reduce the number of firms that are required to retain allegation records and to report to EPA. The Agency invites comments on the benefits or burdens of this alternative compliance method and whether it should be included in the final rule. To avoid duplicating records that already exist, this rule proposes an alternative compliance method for keeping consumer complaints. Firms may already keep records that may be required by this rule because of requirements in regulations carrying out section 16(b) of the Consumer Product Safety Act (CPSA). If so, these firms would not be required to make copies of these CPSA records to include as part of the section 8(c) record. However, firms would keep consumer complaints for the length of the time outlined in this proposal and would report them as required by this rule. The Agency also thinks that the CPSA records should be retrievable in the same way as section 8(c) records. For example, records should be filed by chemical or article identity. The proposed rule therefore states that they must be retrievable in the manner outlined for section 8(c) allegations and forms, in section 717.15 of this-proposed rule. The Consumer Product Safety Commission (CPSC) has proposed (see 42 FR 57642), but has not yet promulgated final rules under section 16(b) of the CPSA. This alternative would be available only when those final rules have been promulgated. The Agency is concerned that there is no "feedback'' mechanism for allegers to learn of any actions which may result from submitting an allegation to a company. Persons who make allegations will do so to protect themselves and others from similar effects in the future, and should know the outcome of their allegation. The Agency requests comments on the kinds of feedback mechanisms that EPA could require, how such mechanisms should be implemented, and who should be subject to such a requirement. An employee making an allegation is afforded protection from employer reprisal. TSCA section 23(a) provides that "No employer may discharger any employee or otherwise discriminate against any employee * * * (who) assisted or participated * * * in any other action to carry out the purposes of this Act." An employee who believes that he has been discriminated against may file a complaint under section 23 with the Secretary of Labor. Reporting Requirements ^ As proposed, this rule would require firms to submit certain allegations upon the request of the Agency. A firm would then be required to transcribe data from the allegation records to a one-page, pre-printed EPA form for admission. In addition, the Agency plans to include in the final rule a requirement for firms to automatically report allegations to EPA. Section 717.16(b)(1) of the rule has been reserved for such an automatic reporting provision. The purpose of this provision would be to make the Agency aware of any unusual pattern of effects of unsuspected chemical problems. To detect such patterns, the Agency proposes to handle allegations reported under section 8(c) in a manner similar to that now used for substantial risk notices under section 8(e). First, each allegation will be carefully studied. The assessor will place the allegation in its proper context by also referring to existing literature on the chemical's toxicity and uses, examining available exposure data, and searching for other similar adverse reactions which are previously known. Should this study uncover a problem that warrants further . investigation, the Agency may request other related information from the firm that submitted the allegation. Through this method, the Agency hopes to detect problems not previously recognized as serious or to uncover problems that have gone unnoticed. If the initial study finds that there may be a problem, but that it may be best handled under another authority, the allegation may be referred to OSHA, CPSC, or other EPA program offices. Each allegation will be entered in a data base that will extend the usefulness of the allegation. Primarily, the data system will permit EPA to track from one place all allegations reported to the Agency from anywhere in industry. Here agaip, by building an historical file, the Agency hopes to be able to detect patterns that were previously not recognized. A further statistical use will be to monitor the effectiveness of the final rule by allowing easy review of the types and numbers of allegations reported to EPA. The Agency is concerned that automatic reporting be designed to result in the reporting of allegations that can be reasonably analyzed. The . Agency is particularly concerned by comments from industry (see minutes of August 15.1979 meeting. Public Record) that companies are often deluged with complaints after introducing any new or changed product. It may be that the sheer numbers of such allegations would overload the EPA's analytical resources if the complaints are about health effects. It is also possible that the numbers of chemical consumer products encountered by an individual consumer would make it unlikely that a consumer will be able to identify any one as a cause of a recordable adverse reaction. Therefore, the Agency is considering whether consumer allegations should be subject to reporting in a different manner than other allegations or should perhaps be exempt from automatic reporting. EPA requests comments on the best approach. EPA is considering an automatic reporting system in which companies would forward allegation records to EPA whenever three are received in a twelve-month period for the same chemical substance, mixture, process.or Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules 47011 site discharge. The threshold number is a matter on which comment is solicited. The suggested threshold of three is based on the fallowing considerations. The threshold must be a reasonable one in the context of several situations including plant neighbor allegations and consumer allegations, as well as employee allegations. We considered that the source of employee allegations about any one chemical or process will be a relatively small group of workers, even if the company is quite large. For instance, a threshold of ten to twenty allegations would be too high if there were only twenty to thirty workers involved in a process. On the other hand, three allegations from a group of thirty workers may indicate that a workplace problem is developing. Similarly, three allegations about a plant effluent would be unlikely to be simple coincidence and may indicate a problem. We have also taken into account the fact that the Conference Report on TSCA contains a statement that "[bjecause the ultimate significance of adverse reactions is difficult to predict, the conferees intend that the requirements to retain records err on the side of safety". We helieve that this Congressional advice applies equally to reporting under section 8(c). The Agency is considering alternative definitions for the automatic reporting threshold. One option under consideration is to apply the threshold over a time period other than twelve months, up to as long as five years. Other options under consideration, which might subsitute for or complement the automatic reporting threshold, could require firms to immediately report to EPA: (a) Any allegation of carcinogenic, mutagenic, tertatogenic or reproductive effects; fbj Any allegation that involves: - (1) A new chemical substance (i.e., any substance that was reported to EPA under the premanufacture notification requirements of Section 5(a)(1)(A) of TSCA); (2) A chemical substance that has been recommended by the Interagency Testing Committee for priority consideration by EPA; or (3) A chemcial substance that is the subject of a proposed or final rule under Section 4, 5, or 8 of TSCA; (c) Any allegation made by a representative of organized labor or any State or local government; or (d) Any allegation that involves a chemcial substance which had been the subject of a previous section 8(c) report by that firm. . These possible alternatives, or some combination of them, may be adopted in the final rule and should be carefully considered in comments on this proposal. The Agency is considering other methods of obtaining reports of section 8(c) allegations. In lieu of the threshold approach discussed above, the rule could require an annual statistical report of numbers of allegations received on chemical substances, mixtures, processes, and site discharges. The Agency invites comment on the statistical approach as well as suggestions of other alternatives. The final decision will take into account all comments on the alternatives and comments on the definition of "significant adverse reactions," since the two are interdependent. In connection with automatic reporting under this rule, EPA believes the company headquarters should be responsible for reporting to EPA. The Agency thinks that this approach is logical because a firm's headquarters would be in the best position to aggregate allegations if the company has several plant sites. Placing the responsibility for automatic reporting on the company headquarters ensures that firms and EPA will be made aware of potential problems that occur in a number of plant sites, even if only one or two allegations are filed at each individual site. To simplify reporting, only company headquarters would report to EPA, and then would send only copies of the EPA standard form to the Agency. The headquarters would be required to send these copies to the Agency within fifteen days of the time the reporting threshold is reached. Subsequent allegations concerning the same cause would also be submitted to EPA if received within a year after the initial submission. Reporting by headquarters would also be required if the automatic reporting provision prescribes an annual statistical report instead of "threshold" reports. The Agency would like comments on these aspects of automatic reporting. To avoid duplicating reports, the proposal contains a provision which would exempt firms from the automatic reporting requirement if a firm's investigation of a section 8(c) allegation has resulted in the firm's filing a report with EPA under section 8(e) of TSCA (substantial risk notification), or with the Consumer Product Safety Commission under section 15(b) of the Consumer Product Safety Act (substantial product hazard notification). The proposed rule also contains a provision to protect the privacy of individuals. Specifically, firms are to omit names (or any other identifiers of individuals who have made allegations) when they report to EPA, unless EPA specifically requires names to be submitted in a particular case. To help the Agency design the automatic reporting provision and predict its effects, discussions have been held with industry and other interested persons. Meetings were held on November 11,1978, and August 15,1979. to discuss the provisions of the rule and solicit information about the numbers and types of allegations now received by industry. Some useful information has been submitted to EPA. although more complete data are expected in response to EPA requests for industry assistance in this matter. Obtaining information on allegations Industry currently receives will enable EPA to determine an automatic reporting requirement threshold that will serve the Agency's purpose without unnecessarily burdening industry. The automatic . reporting threshold which EPA finally determines will depend on the extent to which industry submits complete information and accurate numbers. In the absence of accurate data from industry, EPA will determine an automatic reporting threshold from best estimates based on the information in the Agency's possession or gathered from other sources. .. A "Reports Impact Analysis" has been prepared to estimate costs of a . requirement that allegations be reported when three are received by a company in a twelve-month period. This document is in the public record available for review in the OPTS Reading Room. In this document are the basic costs of recording, filing, and reporting allegations; using an adjusted multiplier, the basic costs can be reapplied to any reporting requirement. Basically, the analysis found that automatic reporting will constitute the smaller fraction of the total costs of this rule to industry, with most costs resulting from the recordkeeping requirement This estimate is a result of industry comments (see item 4 of the record described at the end of ths preamble] on previous drafts of this rule. These comments indicated that few allegations are received by firms each year. However, previous comments addressed a narrower definition of "significant adverse reactions" than the one in this proposal. The Agency specifically requests information about the number of allegations industry can expect to receive in view of the proposed definition. The Agency will consider conducting a pilot test of any final automatic reporting requirements. The method of 47012 Federal Register / Vol. 45, No. 135 / Friday, July 11. 1980 / Proposed Rules conducting such a test could be to select certain segments of the potential respondents and require those persons to submit reports in accordance with the automatic reporting provision. Reports submitted over a specified period of time would be assessed before applying the requirement to all persons who keep records of allegations under section 8(c). The Agency is concerned about the broad impact that may result from reporting, in terms of both the number of respondents who may have to submit reports and the number of reports EPA may have to assess. Thus, a pilot test may determine the number of reports that would be submitted in relation to the number of allegations received. The Agency may be better able to estimate the impact on industry of a reporting requirement and to project the kinds of information reports may yield. In considering the need to test any reporting requirement EPA will examine information submitted in response to this proposal and determine the need to learn more about the numbers and content of allegations now received by industry. The Agency invites comments on the need for a pilot test the objectives of such a test and procedures for selecting industrial segments for the test Existing Records Many firms may already keep records of allegations of significiant adverse reactions. Existing records may vary in terms of the content and manner in which they are filed. The proposed rule would~not require firms to reorganize their records to conform with EPA's recordkeeping and automatic reporting requirements. However, firms are requested to review records of allegations received after enactment of TSCA (January 1,1977) and before promulgation of this Part to determine if there are three or more allegations, as defined in this Part, that implicate any one substance, mixture, article, operation, or site discharge. If three or more allegations were recorded within any twelve-month period, the Agency requests that the allegations be transmitted to EPA. Economic Impacts The Agency can only estimate the number of allegations which may be received by industry and the costs which may result from the proposed rule. A review of the industries potentially subject to keeping records indicates that over 600,000 firms with approximately 20 million employees may be affected (see Appendix B, Reports Impact Analysis). Processors of chemical substances and mixtures may be found across the spectrum of mining, manufacturing, and wholesale trade industries (SIC codes 10-14, 20, 22-28. 31-39,49-51). Analysis of the possible burdens to industry indicates that the highest likely annual recordkeeping cost to ail of industry will be $450,000. Preliminary estimates are that 10,000 20.000 allegations may be received and filed annually, with an estimated cost of $22,500 to process each allegation. If an automatic reporting requirement were to result in 5% of these allegations being submitted to EPA (at an estimated cost of $55 per allegation package), the additional annual cost to all of industry would be $18,150. The Agency invites comments that estimate the number of allegations which may be received annually and the costs which may result from both recording and reporting to EPA. The reasoning behind the estimated costs is described in the "Section 8(c) Reports Impact Analysis". The analysis covers the costs for a company to receive, process, and file an allegation, and also the numbers of allegations which may be received annually by industry. These estimates are used to calculate the lowest and highest costs to industry which may result from keeping the section 8(c) records. The lowest and highest costs to industry from automatically reporting allegations to EPA are also estimated. While the analysis examines the costs to report three independent allegations .received in a twelve-month period, we have extended that analysis to show the likely costs from different levels of reporting to EPA. The "Section 8(c) Reports Impact Analysis" is part of the Public Record and may be obtained by writing or calling the Industry Assistance Office, Office of Pesticides and Toxic Substances (TS-799), U.S. Environmental Protection Agency, 401M Street, SW, Washington, DC 20460, 800 424-9065; in Washington call 554-1404. Confidentiality Firms may assert a claim of business confidentiality for all or part of any records. EPA is aware of the need to maintain the confidentility of any legitimate trade secret. Confidential information will be safeguarded as provided in the `TSCA Confidential Business Information Security Manual" adopted by EPA in July, 1978. Any claims of confidentiality must be made at the time of submission, and substantiated as described at 40 CFR 2.203(a)(2), within 15 working days of submission, and in the manner specified in | 717.17 of this proposed rule. This rule would require submission of two copies of records containing confidential material--one copy indicating what data are claimed as confidential and one copy without the confidential information. EPA will consider failure to submit two copies as a waiver of the confidentiality claim. However. EPA will notify firms who claim parts of records confidential if they did not submit the required two copies. This provision affords persons the opportunity to correct errors and thus prevent data claimed as confidential from being placed in the public file. To ensure proper handling, submissions must be addressed to the Document Control Officer of the Office of Pesticides and Toxic Substances. Sunset Provision Internal EPA regulations state that new reporting requirements will contain a provision for repealing that requirement on a specific date within five years after their promulgation. This proposed rule is exempt from the imposition of such a "sunset" requirement because the records are required by statute. However, the rule will be reviewed periodically in the years after it is promulgated to study its effectiveness and associated burdens. EPA will consider comments received from any source on the effectiveness of the rule, with the aim of reducing the burden on affected parties while satisfying the provisions of section 8(c). Public Meetings - During the 90-day comment period, EPA staff responsible for developing this proposal will be available to meet with interested persons from individual companies, organized labor, trade associations, and environmental or consumer organizations. Most meetings will be held at EPA in Washington, D.C. However, to facilitate state and local comments, the Agency will hold one or two meetings outside of Washington, D.C., in a locale central to a large group or groups requesting the meeting. The Agency will determine time and place based on demonstrated need and interest. s. EPA will provide facilities and make other necessary arrangements for such meetings. The meetings will be open to the public and the Agency will make transcripts or summaries of the meetings for inclusion in the public record. Anyone interested in requesting a meeting or in learning the schedule of meetings may call the Industry Assistance Office at 800-424-9065 or, in Washington, 554-1404. EPA encourages the public to use the Industry Assistance Office's toll-free telephone service during the early part of the comment period in order to clarify Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules 47013 its understanding of the proposal and develop comments. EPA also encourages the public to use the opportunity for meeting-by-request, as offered above. The Agency has found that such meetings make it easier for the public to give EPA a sense of the predicted costs and process of compliance. Case-studies, impact analyses, interpretations of definitions used in the proposed rule, and thoughts oh how a proposal would work in practice are particularly helpful to the Agency. Such material or experience, while it underlies them, often are not conveyed in written comments. Presentation of such material in a roundtable format enables the commentator to talk-and-walk his way through an anticipated impact and EPA to cross-check on the spot his meaning and assumptions. The Agency has found this sort of exchange enhances significantly the utility of such commentary. Public Record EPA has established a public record for this rulemaking (docket number OTS 083001). The record, along with a complete index, is available for inspection in the OPTS Reading Room, 447 East Tower, from 9:00 a.m. to 5:00 p.m. on working days (401M Street SW., Washington, DC 20460). This record includes basic information that the Agency considered in developing this proposed rule. The Agency will supplement the record with additional information as it is received. The record includes the following categories of information: 1. This proposed rule. 2. The Advance Notice of Proposed Rulemaking, published in the Federal Register on March 11,1977 (42 FR 13579). 3. All comments on that Advance Notice. 4. A draft of this proposed rule, dated October 12,1978, sent to selected industry, labor, and public interest groups. 5. All letters of transmittal sent with that draft and comments received on it 6. Minutes of a November 13,1978 meeting with industry and special interest groups to discuss the TSCA section 8(c) draft rule. 7. "Notification of Substantial Risk Under Section 8(e)," March 16,1978 (43 FR 11110), and comments received. 8. Occupational Safety and Health Administration regulations on "Recording and Reporting Occupational Injuries and Illnesses" (29 CFR Part 1904), and forms revised in 1978. 9. Consumer Product Safety Commission proposed reporting requirements regarding recordkeeping of Authority: Sec. 8(c), Pub. L. 94-469.90 Stat. consumer product safety complaints, 2029 (15 U.S.C 2607(c)) November 3,1977 (42 FR 57642). 10. Consumer Product Safety Commission interpretation of policy for "Reports of Substantial Product Hazards," August 7,1978 (43 FR 34988). 11. "Final Report on the Economic Impact of Proposed Recordkeeping Rules to Deputy Associate Executive Directorate for Economic Analysis, U.S. Consumer Product Safety Commission," Battelle, Columbus, Ohio, March 19, 1979. 12. Minutes of an August 15,1979 meeting with industry and special interest groups to discuss the TSCA section 8(c) draft rule. EPA anticipates adding to the rulemaking record the following types of information: 1. All comments on this proposed rule. 2. All relevant support documents and 717.11 Scope and compliance. (a) Section 8(c) of the Toxic Substances Control Act (TSCA) requires manufactures, processors, and distributors of chemical substances and mixtures: (1) To keep "records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture"; and (2) to "permit inspection and submit copies of such records", upon request of any designated representative of the Administrator. This rule implements section 8(c) of TSCA. It describes the records to be kept and prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator. studies. (b) Section 15(3) of TSCA makes it 3. Records of all substantive unlawful for any person to "fail or communications between EPA refuse to (1) establish or maintain personnel and persons outside the records, (2) submit reports, notices or Agency. (This does not include any other information, or (3) permit access to inter- or intra-agency memoranda unless or copying of records as required by this specifically noted in the index of the Act or a rule thereunder*1. Section 16 rulemaking record.) states that violating section 15 makes a 4. Minutes, summaries, or transcripts person liable to the United States for a of any public meetings held to develop civil penalty and possible criminal this rule. prosecution. Under section 17, the 5. Any factual information considered district courts of the United States have by the Agency in developing the rule. jurisdiction to restrain any violation of EPA will designate the complete section 15. rulemaking record, as prescribed by section 19(a)(3) of TSCA, on or before 717.12 Definitions. the date the regulation is promulgated, The definitions set forth in Section 3 and will accept additional material for of TSCA and the following definitions inclusion in the record at any time apply to this part: between this proposal and such (a) "Allegation" means a statement, designation. The final rule will also made without formal proof or regard for permit persons to point out any errors or evidence, that a chemical substance or omissions in the record. mixture has caused an adverse reaction Note.--EPA has determined that this document does not contain a major proposal that requires preparation of a Regulatory to health or the environment. (b) "Firm" or "company" means any person that is subject to this rule, as Analysis under Executive Order No. 12044. defined in 717.13, below. EPA proposes to establish a new 40 CFR Part 717 as set forth below. Dated: )une 27,1980. Douglas M. Costle, Administrator. ' (c) "Manufacture" or "process" means to manufacture or process for commercial purposes. (d) (1) "Manufacture for commercial purposes" means to import produce, or manufacture with the purpose of PART 717-RECORDS AND REPORTS OF ALLEGATIONS OF SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT obtaining an immediate or eventual commercial advantage for the manufacturer, and includes, among other things, such "manufacture" of any amount of a chemical substance or Sec 717.11 Scope and compliance. 717.12 Definitions. 717.13 Who is subject to this Part. 717.14 Which allegations must be kept. 717.15 Recordkeeping requirements. 717.16 Inspection and reporting requirements. mixture, (i) For distribution in commerce, including for test marketing, and (ii) For use by the manufacturer, including use for product research and development, or as an intermediate. 717.17 Confidential business information. | 47014 Federal Register / Vol. 45. No. 135 / Friday, July 11. 1980 / Proposed Rules (2) "Manufacture for commercial purposes" also applies to substances that are produced coincidentally during ther manufacture, processing, use. or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose. (e) "Person" includes any individual, firm, company, corporation, joint- venture, partnership,' sole proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body, and any department, agency, or instrumentality of the Federal Government. (f) "Process for commercial purposes" means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical substance or mixture containing impurities is processed-for commercial purposes, then those impurities are also processed for commercial purposes. (g) "Retailer" means a person who distributes in commerce a chemical substance, mixture, or article to ultimate purchasers who are not commercial entities. ' (h) "Significant adverse reactions" are reactions which may indicate a tendency of a chemical substance or mixture to cause long-lasting or irreversible damage to health or the environment. In addition to obvious indicators such as major human diseases or ecological damage, such indicators include: (1) Health effects, (i) Which, although they persist only for the duration of exposure, such as nausea or impaired vision, are experienced repeatedly by a person upon exposure to the substance; (ii) Which persist beyond the period of exposure, such as prolonged headaches or loss of muscle control; or (iii) Which occur after cessation of exposure, such as sterility or delayed neurotoxicity; and (2) Environmental effects, even if they are restricted to the environs of a plant or disposal site, such as gradual or - sudden changes in the composition of plant or animal life in an area. Examples of this are: (i) Abnormal numbers of deaths of animals or plants, (e g., fish kills); (ii) Reduction of the reproductive success or the vigor of a species: (iii) Reduction in agricultural productivity, whether crops or livestock; or (iv) Alterations in the behavior or distribution of a species. (1) "Site" means a contiguous property unit. Property divided only by a public right-of-way is considered one site. There may be more than one manufacturing plant on a single site. (j) "Substance-" means a chemical substance or mixture unless otherwise indicated. 717.13 Who is subject to this Part. All manufacturers, processors, and all persons who distribute substances in commerce except retailers, are subject to this rule. The exemption of retailers does not apply to retailers-who are also manufacturers or processors of the substance in question. 717.14 Which allegations must be kept (a) Firms must keep any allegation of a significant adverse reaction to health or the environment. That implicates a substance by: (i) Naming a specific substance, (ii) Naming an article which contains a specific substance. (iii) Naming a company process or operation in which substances are involved, or - (iv) Identifying an effluent, emission, or other chemical discharge from a site of manufacturing, processing, or distribution of a substance; and (2) That is submitted: (i) In writing and signed, or (ii) Orally, but not anonymously, (A) By an employee to a supervisor, company physician or health unit staff member, or company agent, (B) By any source, such as an individual consumer, a neighbor of a plant, a public health official, or an organization on behalf of its members, to a company agent, public relations officer, or any other appropriate company official. (b) An allegation of a health effect(s) on a single individual shall be counted as one allegation. For example, if an allegation is made in behalf of five individuals, it should be counted as five allegations. An allegation by a single source of an environmental effect shall be counted as one allegation. 717.15 Recordkeeping requirements. (a) Contents of records. (1) Upon receiving each written and signed allegation, a firm must date it and keep it. A firm must write down, date, and keep each oral allegation (including the name of the aileger) that is subject to this rule. All allegations shall be kept in a file designated for this purpose. An allegation is considered received when it is first reported to or known by a supervisor, company physician or health unit staff member, or any other appropriate company official. (2) A firm must keep the data described in paragraph three of this section, either on EPA Form No. 7710-29, or by the firm's own recordkeeping method, and link the data to the written allegation by a unique reference number. Oral allegations may be written down initially on the EPA form. The data required by paragraph three must be kept with the original allegation. EPA Form No. 7710-29 is available from EPA Regional Offices or by writing or calling the Industry Assistance Office. Office of Pesticides and Toxic Substances (TS- 799), Environmental Protection Agency, Washington, DC 20460, 202-554-1404 or 800-424-9065 (toll free). (3) Firms must record the following: (i) The name of the company; the name and address of the plant site which receives the allegation; the name, title, and telephone number of the company official whom EPA can contact for ' fiirther information; and the date the allegation is received. , (ii) The implicated substance, mixture, article, company process or operation, or site discharge (see paragraph four of this section). (iii) A description of the aileger (e.g., "company employee", "individual consumer", "plant neighbor"). If the allegation involves a health effect, the sex and year of birth of the individual should be recorded. (iv) A description of the alleged health effect(s). indicating whether the effect(s) is prolonged, recurrent or incapacitating. The description must relate how the effect(s) became known and the alleged route of exposure, if ascertainable. * (v) A description of the nature of the allaged environmental effect, identifying the affected plant or animal species. (4) Allegations must be filed according to one of the following: (i) Chemical substance identity: (ii) Mixture identity, if the implicated chemical substance cannot be identified: or (iii) Identity of the article, company process or operation, or site discharge involved, if the implicated chemical substance or mixture cannot be identified. (5) The results of any company investigation or further required report that is made following a particular allegation must be kept by the firm with Federal Register / Vol. 45, No. 135 / Friday, July 11. 1980 / Proposed Rules 47015 the allegation and the corresponding allegations are also subject to the EPA form or company record. For retention and reporting requirements of example, if an employee allegation this rule. Firms must transcribe those results in a requirement for the firm to record the case on Occupational Safety and Health Administration Form 101 or appropriate substitutes (see 29 CFR Part allegations to EPA Form No. 7710-29 only if they become subject to the reporting requirement of 717.16. 1904 for requirements under the 717.16 Inspection and reporting Occupational Safety and Health Act of requirements. 1970), a copy of the OSHA record must (a) Inspection. Firms must make be included in the allegation Hie. records of allegations available for (b) Retention period. Firms must keep inspection by any duly designated records relating to employee allegations - representative of the Administrator. (whether submitted by or on behalf of (b) Automatic reporting. the employee) for 30 years from the date (1) (Reserved] they are received; all others must be (2) Whenever an investigation of an kept for five years. allegation(s) has resulted in a report to (c) Location ofrecords. Firms must keep copies of the allegation, EPA Form No. 7710-29 or the company form or file, the EPA under section 8(e) of TSCA (substantial risk notification, see 43 FR 11110, March 16,1978) or a report to the and the results of any follow-up investigation at the site where they are received. Copies of the EPA form or company form or file must also be kept at company headquarters if this differs from the site where the allegation is received. (d) Transfer ofrecords. (1) If a firm ceases to do business, the successor must receive and keep all the records that must be kept under this rule. (2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted by registered mail to EPA. (e) Alternative compliance methods. (1) Distributors can satisfy the requirements of this rule by establishing and carrying out procedures for sending allegations to the appropriate processor or manufacturer within five days of receiving them. Distributors must keep a log of transmitted allegations, showing the name and address of the manufacturer or processor to whom the allegation was forwarded, the date on which each allegation was forwarded, and a brief description of the implicated chemical substance, mixture, article, or site discharge. The distributor must keep this log for thirty years for employee allegations and five years for others. This alternative compliance method does not apply to distributors who are also processors or manufacturers of the substance in question. (2) Firms may keep allegations which are also subject to recordkeeping requirements under section 16(b) of the Consumer Product Safety Act in the manner required by the Consumer Product Safety Commission (see 16 CFR 116). However, those allegations must be retrievable according to the requirements of 717.15(a)(3). Those Consumer Product Safety Commission under section 15(b) of the Consumer Product Safety Act (substantial hazard notification, see 16 CFR Part 1115), the requirement for automatic reporting under this section will be considered waived by the EPA. (c) Other reporting. At the request of any duly designated representative of the Administrator, each person who is required to keep records under this rule must transcribe the allegation to EPA Form No. 7710-29 and submit copies of those forms. EPA will announce any such requirements for submitting records, apart from automatic reporting under paragraph (b) of this section, by a notice in the Federal Register if large numbers of firms are involved. When only a few are involved, EPA will announce the requirements by letters to appropriate firms, signed by the Assistant Administrator for Pesticide and Toxic Substances or his designee, and will specify which records must be submitted. (d) How to report. Firms must submit records (preferably by certified mail) to the Document Control Officer, Office of Pesticides and Toxic Substances (TS793), Environmental Protection Agency, Washington, DC 20460. (e) Privacy. Firms must omit names or other identifiers of individuals who have made allegations whenever they appear in records forwarded to EPA under paragraph (b) of this section, in order to avoid jeopardizing the privacy of those individuals. EPA will require the names of individuals only for purposes of follow-up investigations. EPA will then explicitly request the records in a Federal Register notice or letter as indicated under paragraph (c) of this section. 717.17 Confidential business information. (a) Firms may assert a claim of business confidentiality covering all or part of any records they submit. EPA will not disclose information covered by a claim except in accordance with the procedures set forth at 40 CFR Part 2, as amended on September 8,1978,43 FR 39997 and March 23.1979,44 FR 17673. Firms claiming confidentiality on any portion of allegations reported to EPA must substantiate that claim of confidentiality in writing to EPA within 15 days of reporting the allegations to EPA- Written substantiation must accompany any records submitted under i 717.16(c). (b) Section 14(b) of TSCA states that EPA may not withhold from disclosure, on the grounds that they are confidential business information, health and safety studies of any substance that has been offered for commercial distribution, or for which testing is required under TSCA section 4, or for which notice is required under TSCA section 5, except to the extent that disclosure of data from such studies would reveal: (1) Processes used in the manufacturing or processing of a chemical substance or mixture, or (2) The portion of a mixture comprised by any of the chemical substances in the mixture. ..' _ Any respondent who wishes to assert a claim that part of a study should be withheld form disclosure because disclosure would reveal a confidential process or quantitative mixture composition should explicitly explain the basis of the claim and clearly demarcate the material subject to the claim. - (c) If no claim of confidentiality is made for the records submitted to EPA, they will be placed in an open file, which will be available to the public without further notice to the firm. (d) To assert a claim of confidentiality for data contained in records, firms must submit two copies of the record: (1) One complete copy for internal EPA use must specifically indicate the data that the firm claims as confidential, by designating and marking the information on each page with a label such as "confidential", "proprietary", or "trade secret". (2) The second copy must not contain any of the information claimed as confidential in the first copy; this copy will be placed in an open file that is available to the public. 47016 Federal Register / Vol. 45, No. 135 / Friday. July 11. 1980 / Proposed Rules (3) If the firm does not provide the second copy, EPA will notify the firm by certified mail. If EPA does not receive the second copy within ten days after the firm receives the notice, the first copy will be placed in the public file. (e) Nothing in this section precludes EPA from withholding information in an allegation if disclosing that information would be an unwarranted invasion of personal privacy. 40 CFR Part 717 Records and Reports of Allegations of Significant Adverse Reactions to Health or the Environment Appendix I The following is the proposed form to record and report BILUNG CODE 6560-0l-M Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules 47017 ERA Form 7710*29 02-79) 47018 Federal Register / Vol. 45. No. 135 / Friday. July 11, 1980 / Proposed Rules WHO MAY COMPLETE THIS FORM An employee's supervisor, s company physician or health unit, a company agent, public relations officer or any other responsible com pany official. Section I Enter the addresses of the company headquarters making the report and the plant site where the allegation was received. Section II Write the name of the chemical material which is alleged to have caused a significant adverse reaction to health or the environment. If a specific chemical substance cannot be identified, then identify the material by the most specific of the following: s MIXTURE, an ARTICLE or PRODUCT, an industrial PROCESS or OPERATION, or an EFFLUENT. EMMISSION. or other industrial SITE DISCHARGE* Indicate the CAS number if a chemical substance is specified. A unique reference number must be included on this form that links it to the original written allegation, and this form must be kept in the same file as the original allegation. SECTION Ml Check the box that best describes the source of the allegation. The name of the individual male ing the allegation should NOT be included on this form. If the box "Other" is used, provide further identifica tion of the source fe.g., company name, conauner group, public health organisation, etc.). BILLING CODE 6560-01-C If the allegation involves a health effect, the sex and year of birth of the person making the allegation should be recorded, if possible. Check the box or boxes which best describes the alleged effect(s). If the allegation concerns an environmental effect, in addition to checking the box, give the name of the ammal(s) or piant(s) alleged to have been affected in the space provided. Section IV Describe, in the words of the person making the allegation when posible, the effect(s) and indicate whether it is PROLONGED. RECUR* RENT or INCAPACITATING if appropriate. Briefly describe how the effect(s) became known and the alleged route of exposure. Allega tions naming cancer as a health effect should specify the body site (o.g., liver; and clearly describe the cancer. Any clarification of the allegation, known explanation of the cause, or extenuating circumstances should be included if known at the time this form is filled out. The results of a follow-up investigation should not be included in this Section, but should be filed with this form as a separate statement. This Section may be continued on the reverse of this form and an at tached sheet of paper if additional space is needed to give a com plete description. . Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules 47019 Section 8(c) Reports Impact Analysis Legal Authority 1. Section 8(c) of the Toxic Substances Control Act (TSCA) requires all manufacturers, processors, and distributors of any chemical substance or mixture to keep records of significant adverse reactions to health or the environment alleged to have been caused by the chemical substance or mixture. Employee allegations must be kept for 30 years, and all others for five years. Records required to be maintained will include consumer allegations of harm to health, reports of occupational disease, and complaints of injury to the environment from any source. Each person required to maintain these records must permit their inspection and submit copies upon request by any duly authorized representative of the Administrator. 2. Background a. Purpose.--The proposed rule will tell manufacturers, processors, and wholesale distributors what kinds of allegations to record and when to report them to the EPA. This rule will serve two major purposes: (1) To establish an historical record to be examined whenever a chemical is discovered to present a possible risk: and (2) to reveal patterns of adverse effects or unsuspected chemical problems which should be considered during the hazard assessment process. The Office of Testing and Evaluation (OTE) of the Office of Pesticides and Toxic Substances (OPTS), will review, analyze, and follow-up the allegations retained and submitted as a result of the section 8[c) requirement in TSCA- The Assessment Division, the Health Review Division, and the Environmental Review Division will study the submissions for signs of a hazard which may warrant further investigation or testing. Allegations that are submitted will be evaluated in an assessment document which will be abstracted for addition to the OPTS Chemicals In Commerce Information System (CICIS). That information will be used to (1) supplement data already known. (2) indicate an increase of a chemical substance's known hazard potential. (3) call attention to chemical substances previously considered to not present a hazard, or (4) identify previously unknown hazards. The Agency can then, as appropriate, use TSCA authorities to (1) require testing (section 4). (2) require submission of a significant new use notice (section 5), (3) ban or limit the manufacture or use (section 6). (4) declare an imminent hazard (section 7). or (S) require the reporting or retention of information that can be used for future analyses (section B). b. Procedural Description.--Firms subject to this rule will record written and oral allegations that implicate one of their chemical substances, by naming the chemical substance or mixture, or naming articles, industrial operations, or industrial site discharges that implicate a substance. These allegations will be stored in a file dedicated to section 8(c) allegations, and retained for 30 years (employee) or five years (all others). Distributors may forward to the appropriate manufacturer or processor any allegations received on that product, if they maintain a log containing specified information. During the comment period for this proposal, the Agency will determine the conditions under which companies are to automatically report allegations to EPA. For the purposes of this analysis, it is hypothesized that whenever three allegations implicating the same cause are received within 12 months, the firm must forward copies of the standard EPA form to EPA within fifteen days after receipt of the third allegation. Section 8(c] reporting would be waived if the allegations result in a "Notice of Substantial Risk", under section 8(e) of TSCA. or a "Substantial Hazard Notification", under section 15(b) of the Consumer Product Safety Act. Approximately 40,000 establishments that manufacture, process or distribute chemical substances and another 543.000 establishments which may process these substances will be subject to this rule. (See Appendix A to this report.) Retail distributors are exempted in this proposed rule, and other distributors may forward allegations to the appropriate manuracturer or processor. c. Unavailability From Other Data Sources.--Records required by the Occupational Safety and Health Administration (OSHA) were examined as a possible substitute for the section 8(c) employee allegations. However, section 8(c) provides the means to allege the presence of a possible problem, without any proof. The OSHA Form 101 (see 29 CFR1904) is intended to record accidents or document the cause of an injury, which is several steps . beyond an allegation. The proposed rule directs that copies of any OSHA record that results from an allegation will be maintained with the section 8(c) record of the allegation. The proposed rule does offer an alternative compliance method for retaining allegations or consumer complaints which are subject to recordkeeping requirements under section 16(b) of the Consumer Product Safety Act. These allegations have only to be filed and reported according to the requirements of this proposal. 3. Alternatives (a) Automatic Reporting Alternatives. A number of variations are possible for an automatic reporting provision. In this Reports Impact Analysis, we have estimated costs of submitting allegations to EPA whenever three independent allegations are received on one chemical substance, mixture, article, process, or site emission in a twelve-month period. One alternative under consideration is to apply the threshold over a period of time other than twelve months, up to as long as five years. Patterns emerging over a longer time frame would have a better chance of discovery, yet the recordkeeping and file search burden would be increased for respondents. Other options under consideration might substitute for or complement the automatic reporting threshold. The rule could require firms to immediately report to EPA any allegations of specified effects (e.g., carcinogenic, mutagenic, teratogenic, or reproductive disorders). In addition, the rule could require firms to immediately report allegations about certain specified types of substances (e.g., new substances reported under Section 5(a)(1)(A) of TSCA, substances recommended by the Interagency Testing Committee, substances which are the subject of a proposed or final rule under Section 4. 5. or 6 of TSCA. or substances subject to previous section 6(c) reports). These alternatives could enable the Agency to examine allegations about selected chemical substances of concern. The Agency could require annual statistical reports or summaries of allegations received. The Agency could exempt individual consumer allegations from automatic reporting, because of the effects that product performance expectations may have on complaints. However, consumer compliants are likely sources of relevant information which could reveal patterns of significant proportions. Another option would be to require that consumer allegations be reported in a different manner than other allegations. The proposed rule requests comments on all of these alternatives. (b) Alternatives to Automatic Reporting. The Agency could rely solely on inspecting records. This would reduce the cost to industry, and reduce the cost of EPA analysis of allegations that are submitted. The Office of Enforcement would have a significantly larger role if inspections were the major method of looking at allegations. The early warning mechanism would be lost, and thus EPA's capability to discover unsuspected hazards would be reduced. (c) Alternative to No Small Business Definition. Different recordkeeping and reporting requirements could be based on the size of a firm. Different requirements would reduce the impact on small business while still covering a large portion of industry. However, there is no small business exemption in section 8(c), and such a provision would reduce the scope of the early warning mechanism resulting from automatic reporting to EPA. . (d) EPA Reporting Form Alternative. Use of the EPA form and the transcription requirement could be eliminated, and only the basic records would be reported to EPA. While this would eliminate a new form and reduce industry's paperwork, it would transfer to EPA the burden of sorting through many formats and kinds of information to properly assess the allegations. The form also provides industry with an additional guide as to what should be recorded, it is a simple onepage form to fill out, it simplifies assessment for EPA by having a standard format, and the form can be easily coded for computer entry. (e) Alternative to Excluding Retail Distributors. All distributors could be subject to this rule, including retail distributors. Such an inclusion would require 1.4 million more businesses to retain and report allegations, and would significantly expand the coverage and impact of this rule. However, the potential for retail employee exposure is comparatively minimal, since retail distribution will mainly involve the handling of packaged products. Consumer allegations regarding name brand products will generally be sent to the manufacturer anyway--either directly by the consumer or indirectly via the retailer. 4. Impact Analysis The following Impact Analysis has been prepared to examine the potential costs and 47020 Federal Register / Vol. 45, No. 135 / Friday, July 11. 1980 / Proposed Rules burdens of the proposed section 6(c) rule, both to industry and to EPA To estimate the costs to industry, we have analyzed the time and probable personnel costs that may be incurred by a company to process and file an allegation once it has been received and recorded. Then, using estimates based on dialogues with industry, we have estimated the numbers of allegations which could be received annually by industry. By multiplying the estimated costs to process an allegation by the estimated number of allegations that could be received, we can make a reasonable estimate of the possible costs to industry from complying with the recordkeeping portion of the proposed rule. In addition, we have analyzed the potential costs to industry of complying with an automatic reporting requirement To do so, we performed an . analysis of the time and personnel cost to prepare and submit several Independent allegations that implicate the same cause. While this analysis examined the cost of only one method of automatic reporting, we continued the analysis so that a range of costs are presented. We feel that the high and low costs of automatic reporting will draw comment and help the Agency examine alternatives. It is emphasized that this analysis, is composed of estimates (which may not be accurate), that those estimates are multiplied against other estimates, and the results may not he wholly realistic. However, for the purposes of analyzing the potential costs of this proposed rule, we feel that the costa presented below are within the range of actual costs. This analysis, as well as the preamhle to the rule, offers our reasoning and solicits comment on many subjects. The Agency is dependent on commentors to offer alternatives to this method of analysis, provide actual figures to plug into our equations, and to improve our estimates. I. Work Hour Reqarrememts/Costs A. Respondents. Approximately 583.000 firms employing 20 million workers will be required to record and report allegat.ons. The following analysis, prepared by the Office of Regulatory Analysis and the Program Integration Division, describes the costs to industry of recording and automatically reporting allegations. Paragraphs two and three below (p. 10) are primarily concerned with "fixed costs", the costs to a company of receiving and filing an allegation. The recordkeeping requirements represent the largest and most costly impact of this proposed rtrie. The proposed costs of automatic reporting are included in paragraph 4 (p. 14) of this analysis because the Agency expects that some form of automatic reporting will be part of the final rule. One hypothetical set of conditions for reporting is presented here--three allegations implicating the same substance received within 12 months. However, the reporting threshold levels will be determined after considering comments on the proposed rule. Therefore, the costs of reporting will be some fraction or multiple of the figures in this analysis, and will depend on the automatic reporting conditions set forth in the final rule. 1. Work Hoar Requirements/Casts Per Allegation The time requirements and cost estimates for processing and submitting section 8(c) allegations are shown in Table 1 (p. 8). As previously stated, we have projected costs from the time an allegation is recorded. The cost estimate does not cover administrative costs to set up a file system or otherwise implement the rule. Further, some firms may design more extensive reviews of allegations than projected in this analysis. These costs are estimated for a typical firm, osing labor cost estimates ok managerial time @ $30/ hour, technical support staff @ $20/hour. and secretarial time @ $10/hour. The unit cost is estimated for an average sized firm. There may be variations from this cost for very large or very small firms. Also a lesser cost would occur for firms operating only one piant site since they would not incur the costs of forwarding the allegations to corporate headquarters. Alternatively, smaller firms may incur higher personnel costs because reviews may be performed by higher level personnel. However, this cost difference should not significantly affect the average. The unit cost estimates given in Table 1 assume the following procedure for handling section 8(c) allegations: a. Processing the Allegation: (i) An oral or written allegation of an adverse health or environmental effect is delivered to the piant manager from either an employee at the plant or from the public. The allegation is logged in by the secretary and reviewed by the plant manager. (ii) The secretary forwards a copy of the allegation to the appropriate officer at corporate headquarters. (iii) The allegation is received at corporate headquarters and reviewed by the appropriate officer. The section 8(c) allegation file is reviewed to determine if a file for the implicated chemical substance or mixture, article, industrial operation or site emission exists that contains other allegations. (iv) A file on the chemical substance is created (if one does not already exist], and the allegation is filed. b. Submitting a Group of Three Allegations Upon Receipt of the Third: (v) The file is retrieved and reviewed by managerial and technical staffs. (vij The allegations are transcribed to the standard EPA form and reviewed by the technical staff for accuracy. (vii) Copies of the file are made, and the submittal package prepared. (viii) The completed submittal package is then forwarded to EPA The "fixed" activity cost in Table 1 represents costs which will be incurred by the firm whenever a section 8(c) allegation is received, regardless of whether the allegation is ultimately forwarded to EPA Since allegations are assumed to be submitted randomly throughout the year there are no appreciable economies of scale. The "variable" cost component represents costs which would be incurred after three allegations had been received concerning a chemical and the three allegations must be submitted to EPA Therefore, the total cost of processing three separate allegations on a chemical and then submitting the group to EPA can be calculated as follows: ($22.50 X 3) + $55.00=$122.50, see Table 1 ' Table I.--Unit Cost of Compliance With Section 8(c) Requirements Activity Time processing allegation Time submitting allegation Fixed activity cost Variable activity cost I. Processing the Allegation Allegation received___________________________ Allegation forwarded lo corporate headquarters.... Allegabdn received at headquarters and reviewed Filed created allegation filed............ .... ................ 0.25 hour clerical............... ......... ................................ NA 0.25 hour managerial-------------------------------------------- NA. 0.25 hour clerical--- -------- ---- ----------------------- -------- na. 0.25 hour managenal.............. ... ......... ... ..................... NA. 0.25 hour secretarial............................... ...................... NA. 2.50 730 230 7.50 2.50 II. Submitting the Allegations to EPA File retrieved. reviewed by managenal and technical stall...... NA. NA. NA Allegation transcnbed to EPA form........................................... NA NA Copies made, materials prepared.......................... NA NA Package sen!............................................................................. NA .. 0.25 hour secretanal.................... _....................... -__ _____ 0.5 hour managenal.............................. ........................... ... 0.5 hour technical................................ ............................ ... 0.5 hour secretanal......................... ..................... ................ ... 0.5 hour technical................................................................... ... 0.25 hour secretarial................................................ .............. .. 0.25 hour managerial....................... _................................... ... 0.25 hour secretarial............................. ........................... 2.50 15.00 10.00 500 to 00 2.50 7.50 230 Totals------- ----- ------ -- 1.75 hour secretarial-- 0.05 hour managenal .... 1.25 hour secretanal.. 0.75 hour managenal. 1.0 hour technical 2230 55.00 Federal Register / Vol. 45, No. 135 / Friday. July 11. 1980 / Proposed Rules 47021 2.Estimated Number of Allegations Received by Firms The Agency has consulted with many sources to develop estimates of the number of section 6(c)-type allegations which are now received by industry. All estimates have had the same problem, namely that there never has been a requirement such as section 8(c). and we do not know for certain how many such allegations might be received annually. Due to the novelty of this requirement and the scant available data, the Agency has based this analysis on assumptions, estimates, and feedback on early drafts of the proposed rule. The groups also estimated the number of allegations that could be received annually based on definitions in an earlier draft of this rule. In that draft, "significant adverse reactions to health or the environment" were defined more narrowly. This proposal broadens the definition and coverage. Additionally, in the earlier draft allegations were to name a specific substance, while this proposal allows persons making an allegation to cite a consumer product industrial process or industrial site emission as the cause without specifying a chemical. These changes will increase the number of recordable allegations (some allegations may not be "recordable allegations" the first time, but may become recordable if the effect is experienced repeatedly by the same person). However, those industry estimates can still serve for estimating the potential number of allegations which may be received annually. EPA has polled several sources to estimate the number of section 8(c)-type allegations received by industry each year. For the most part, the Agency has relied upon the following: (a) Chemical industry and trade association contacts, (b) Past experience of EPA staff with the chemical industry during the development of other section 8 rules, and (c) Comparison with similar data collected by OSHA and BLS.1 1 Firms and chemical industry associations 2 which provided EPA with early estimates of the number of allegations received by chemical firms included: (a) Chemical Manufacturers Association (CMA). (b) Synthetic Organic Chemicals Manufacturers Association (SOCMA). (c) American Texiles Manufacturers Institute (ATMI). 'The OSHA/BLS data on occupational injuries could not be used directly because they include illnesses from all occupational hazards rather than only those caused by exposure to chemical substances. 1 These commentors and others are encouraged to provide estimates on the basis of the requirements proposed, since their estimates were based on an early draft. (d) National Retail Merchants Association (NRMA). (e) National Retail Hardware Association (NRHA). and (f) E.I. DuPont De Nemours & Co. (Inc.) Estimates provided by the chemical industry used the number of company production employees as the basis for measuring the number of allegations received from any source by a company. So. the estimates of probable numbers of allegations a company might receive are based on the number of employees in the chemical industry, regardless of the fact that allegations may be submitted by consumers, plant neighbors, or others. In the case of estimates for section 8(c), the chemical industry used 1.000 employees as the common denominator as follows: Number of allegations of all sorts -r Number of production employees The substance of the chemical industry estimates is that 2-4 allegations will be received annually for every 1000 employees. Since the chemical industry estimates of numbers of allegations are based on employment figures, we reviewed the number of production employees in firms which manufacture, process, or distribute chemical substances or mixtures (see Appendix A-- Estimate of Persons Subject to TSCA Section 8(c)). Firms who manufacture and process chemical substances or mixtures can in large part be readily identifiable within the Standard Industrial Classification (SIC) codes 28 and 2911 (Group 1). However, additional manufacturers, processors, and distributors are spread throughout industry and commerce. "Chemical substance" under TSCA includes naturally occurring chemical substances, such as minerals and metals, and agricultural products, such as cotton. To make an accurate estimate of the section 8(c) impact, a determination was needed as to how many employees in all industries might be involved in the same kind of activity as employees in SIC codes 28 and 2911. The only source of information that comprehensively describes the make up and employment of U S. industry is the Standard Industrial Classification Manual. The limitation of this source is that it classifies industry by end products and does not detail the activities involved in production. Therefore, one must rely on the description of end products to determine whether chemical processing is likely to be a part of the production. In addition, companies are classified according to their major products so it is possible that, for some companies, minor activities involving chemical processing may be missed. The analysis found that large segments of industry may include processors: however, in most of those segments, only a small percentage of the production employees can be expected to be involved in processing chemicals (as opposed to assembly work and other manufacturing activities). Examples of industries with incidental processing activities are apparel manufacturers (SIC 23). fabricated metal products (SIC 34), electrical machinery (SIC 36). and automotive manufacturers (SIC 37). In those segments (called Croup 2 hereafter), chemical processing is expected to be incidental to the manufacture of another article. Therefore, for the purpose of estimating the number of section 8(c)-type allegations (which is based on estimates from the chemical industry), only a portion of the employees in Group 2 were counted. It was estimated that 10% of the employees in Group 2 on the average may be involved in chemical processing during the regular performance of duties. Some . individual companies may be occupied 100% in chemical processing and others may be occupied 1%. As has been previously stated, the Agency has analyzed the costs of this completely new kind of requirement on scanty data and reasonable assumptions. We feel that 10% is a reasonable figure and is a multiplier that can be changed if better information is supplied through comments. Appendix B to this analysis contains a listing of SIC codes that were selected as being either primarily engaged in manufacturing or processing chemical substances (Group 1), or as incidental processors or distributors (Group 2) (see Appendix A). Our review, using Bureau of Labor Statistics figures, concluded that over 583.000 establishments may manufacture, process, or distribute substances. In those establishments, there are estimated to be 3.200.000 employees in Group 1. and 17.200.000 employees in Group 2. The number of workers used to determine the possible number of allegations was the sum of the following equation: Group 1 +(Group 2) (0.10)=Section 8(c) Worker Population=4.9 million employees Rounding off to an even 5 million . employees: (Number of Employees) X (2-4 allegations)1000 employees=Number of Allegations=10,000-20,000 allegations . This means that an average of 10,000 20,000 section 8(c)-type allegations could be received by industry each year. , 3. Recordkeeping Cost Estimates In Table 1 (p.6), we estimate that a. company will expend 2.25 hours to receive and process an allegation (fixed cost), which is estimated to cost S22.50 per allegation. At $22.50 per allegation, for an estimated 10,000 20.000 allegations per year, the annual fixed costs to industry to process section 8(c)-type allegations is estimated to be $225,000-, $450,000. . 4. Automatic Reporting Cost Estimates To assess the probable costs of an automatic reporting provision, we have I 47022 Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules estimated the numbers of allegations that might be submitted by firms to EPA. In addition, using the cost estimates in Table 1 (p.8|, we have estimated the probable cost to industry if an automatic reporting provision is included in the final rule. For the purposes of this analysis, we have estimated the cost of an automatic reporting provision that requires the submission of allegations when three allegations about the same substance are received in a twelve-month period. These allegations would not have to be submitted to EPA except when three independent allegations are received about the same cause. The Agency estimates that only 3-5% of the total number of allegations received by industry will have to be submitted to EPA. The reason for this estimate is that we feel that it is improbable that three independent allegations about the same cause in the same twelve-month period will occur frequently. While this figure is clearly based on assumptions, we believe that this is a reasonable number from which to base cost estimates. If 3-5% of the allegations are reported, this means that EPA expects to receive between 300 (3% of tO.OOO) and 1000 (5% of 20.000) section 8(c) allegations per year. If these allegations are submitted to EPA in groups of three, the Agency anticipates receiving between 100 and 330 submittal packages each year. In Table 1, we estimate that for a firm to review, transcribe, and forward a package of three allegations will require three hours and cost $55. Thus, the estimated annual cost to industry of submitting 100-330 packages of allegations is $5,500-$18,150. We have also examined the possibility that the number of allegations submitted to industry may eventually double as the section 8(c) program becomes more widely known among employees and consumers. The cost estimates for this scenario are summarized in Table 2. Costs to submit packages of allegations have been estimated for three scenarios m Table 2. In these scenarios we have estimated, according to three rates, the probable percentage of the allegations received by industry that could be automatically reported. For each scenario, costs have been computed for the different estimates of numbers of allegations that could be received annually by industry and subject to reporting to EPA. We estimate that industry may receive 10.000-20,000 section 8(c) allegations per year, and we have also computed the costs should industry receive double our estimate, or 40,000 allegations per year. Table 2 contains cost estimates for the following scenarios: Scenario 1 Low reporting rate (3% of allegations received by industry are forwarded to EPA). Scenario 2 "Most likely case" (5% of allegations received by industry are forwarded to EPA). Scenario 3 "Worst possible case" (allegations are distributed such that all allegations received by industry (100%) must be submitted to EPA). Each of these scenarios is broken down into three variations: 10.000--If 10.000 allegations are received by industry each year (2/1000 empl/yr) 20.000-- If 20.000 allegations are received by industry each year (4/1000 empl/yr) 40.000-- If 40,000 allegations are received by industry each year (8/1000 empl/yr) TABLE 2--Estimated Costs of Automatic Reporting BASIS OF COMPITTA TION Fixed Costs (Recordkeeping) (Number of Allegations Received by Industry) X ($22.50) Variable Costs (Automatic Reporting) (Percent of Allegations Submitted to EPA) X (Number of Allegations Received by Industry) -t- (Number of Allegations in Submittal Package] [The product is divided by 3 because the $55 submittal cost is incurred only once for every three allegations submitted] Total Cost to Industry = Fixed Costs + Variable Casts SUMMAR Y OFRESULTS Number of Allegations Received by Industry 10.000 20,000 40.000 Scenario 1: 3% of Allegations Submitted to EPA__ Scenario 2 5% of Allegations Submitted to EPA..... Scenario 3; t00% of Allegations Submitted to EPA.._, $230,500 $231,200 $306,300 $461,000 $922,000 $468,300 $936,700 S816J00 $1,633,300 Total Annual Cost to Industry of Automatic Reporting. The total annual costs to keep and report section 8(c) allegations are estimated to range from a low of $230500 (Scenario 1 at 10.000 allegations) to a high of $1,833,300 (Scenario 3 at 40,000 allegations). It should be noted that the "worst case" scenario (scenario 3) is considered to have nearly a zero probability of ever occurring; it is presented as an illustration of the absolute maximum cost which may be imposed on industry by the section 8(c) program. Similarly, there is a low probability that industry will receive 40.000 allegations per year, which is double the estimate we derived from industry input The costs for the "most likely" case scenario (Scenario 2 at 10,000-20.000 allegations) range from $231,200 to $468,300. depending ultimately on the number of allegations which are actually received by industry. EPA believes these figures from Scenario 2 represent the most realistic estimate of the section 8(c) program costs with automatic reporting included. If the. number of allegations received by industry doubles to 403X10 allegations per year, the estimated annual costs may range from $922,000 (Scenario 1) to $LB33,300 (Scenario 3). - 5. Comparing Recordkeeping to Automatic Reporting Cost Estimates In conclusion. EPA estimates the total short-run cost to industry of the section 8(c) program to range from $230,500 to $816,700 if 10,000-20,000 allegations are received annually. In this estimate, "fixed" recordkeeping cost range from $225,000$450,000. and "variable" reporting costs range from $5,500-318,150. If the size of the program were to double due to increased worker and consumer awareness, the Agency estimates that the total cost to industry would rise to $922.000-$1.633.300. In this doubled estimate, "fixed" recordkeeping costs are $900,000, and "variable" reporting costs range from $22,000-5733.300. Except in the cases of Scenario 3 of Table 2, where 100% of the allegations are reported to EPA, the automatic reporting costs are very small compared to the basic cost of complying with the section 8(c) recordkeeping requirements. In none of these cases is the cost of die section 8(c) program very burdensome to either the industry as a whole or individual firms. B. Agency (EPA) Impacts Evaluation of section 8(c) submissions will require the Agency to devote the following resources: ' 1. Prescreen: (Chemical Information Division) The Document Control Officer receives, records on a log, classifies, and forwards the allegation package to OTE. These activities are estimated to require four hours per submitted package of three allegations. 2. Assessment (Office ofTesting and Evaluation) OTE has dedicated 2Mi person years to assess section 8(c) allegations. Specifically, the Assessment Division and Health Review Division will each devote 1 person year; the Environmental Review Division will devote Vi person year. OTE is uncertain how long each allegation assessment should take, but if the section 8(e) submissions are a valid indicator, then each allegation should require eight hours, or 24 hours per package of three allegations. 3. Data Entry: (Chemical Information Division) The Systems Operations Branch estimates an annual cost of $100,000 for the contractor to abstract and enter section 8 (c), (d), and (e) submissions. These submissions will be entered onto the OPTS CIQS (Chemicals In Commerce Information System). This experience to date is 660 section 8(d) health and safety studies, and 275 section 8(e) notices of substantial risk. The Office of Regulatory Analysis estimates that EPA is likely to receive 1.000 allegations per year, which would represent about double the submissions to now handled by the contractor, and therefore would cost approximately $50,000 a year. - 4. Enforcement (Office of Enforcement) The Office of Enforcement intends to actively enforce this rule. Inspections of section 8(c) files will be conducted in conjunction with inspections performed for other provisions of TSCA and other laws administered by EPA. Present plans to combine inspections means that the rule will have little effect on OE resource allocation. _ II. Secondary Impacts A. Recordkeeping Changes. The requirements of this rule will create a new requirement to record and report allegations: however no new positions (jobs) or primary functions should result from meeting those requirements. Federal Register / Vol. 45, No. 135 / Friday, July 11. 1980 / Proposed Rules 47023 B. Effects on Agency Program Operations. Little effect, beyond that described above, is expected on Agency operations unless the cumber of submissions is considerably more than anticipated. Enforcement activities may be increased if inspections uncover widespread compliance problems. 5. Respondent Coordination During the development of this rule, there have been a number of exchanges with industry representatives. On November 13. 1978. a Work Group meeting was held with representatives from industry (see Public Record in Preamble) at which a draft of the rule was discussed. A public meeting was held on August 15.1979, to discuss this proposed rule, which has several changes from the previous draft (see Public Record in Preamble). This proposal reflects some comments from that meeting, especially concerning the automatic reporting provision. The conditions requiring automatic reporting will be set after considering comments in response to this proposal. Several contacts with the industry helped establish the probable number of allegations that will be received by industry and the costs to industry [see paragraph 4(l)(A)(2) above]. Furthermore, many telephone calls have been received by OPTS from industry representatives that either provided input or concerned the status of the rule. . Appendix A--Reports Impact Analysis Estimate of Persons Subject to TSCA Section 6(c) Introduction ' An effort has been made to define, by Standard industrial Classification (SIC) code, the parameters of the industrial and commercial community which may be affected by the proposed section 8(c) rule. The purpose of this exercise is to examine all industrial categories to determine and list the SIC codes (see Appendix B to Reports Impact Analysis) for those who may manufacture, process, or distribute chemical substances or mixtures as defined in TSCA and may be subject to section 8(c). Under the TSCA definition, a chemical substance includes any naturally occuring substance or combination of substances, such as minerals or cotton. Those who manufacture chemical substances or mixtures, such as organic chemicals, may in large part be readily identifiable within the SIC codes 28 and 2911. However, additional manufacturers, as well as processors and distributors, are spread thoughout industry and commerce. Large segments of industry may include processors: however, in most of those segments, only a small percentage of the production employees can be expected to be involved in the processing of chemicals (as opposed to assembly work and other activities). While the list of industries and * SIC codes is reasonably complete and comprehensive, exclusion of an SIC code from the list should not be construed to mean that persons in that code are not manufacturers, processors, or distributors of chemical substances or mixtures. Some SIC codes were eliminated from the list because there was no clear indication from the description in the Standard Industrial Classification Manual that the industry might manufacture or process any substances. Other SIC codes were excluded because the industries generally appeared to not be within the jurisdiction of TSCA. The selections were made without consulting industry, and it is expected that comments to the proposed rule and this analysis will improve and validate the selection criteria and result in a more comprehensive listing. Purpose This review was conducted to better estimate the potential impact of the proposed section 8(c) rule. Industry has provided estimates to EPA about the number of section 8(c) allegations that are now received annually in a manner that measures the number of allegations received from all sources by the number of industry production employees as follows: Total Allegations Of All Sorts--Number of Production Employees An estimate was derived from industry input which concludes that industry annually receives from any source 2-4 allegations for every 1000 production employees. The number of production employees thus becomes a common denominator to estimate the number of allegations, that might be subject to recordkeeping and reporting under TSCA section 8(c). The purpose of this study is to estimate the number of production workers who could be expected to be involved in the manufacturing, processing, or wholesale distributing of chemical substances or mixtures. Assumptions and Procedures 1. The provisions of section 8(c) are to be applied to all persons who manufacture, process, or distribute chemical substances or mixtures in commerce except retailers. This will include persons in the chemical and allied products industry; those who distribute those products in commerce: and industries outside the traditional "chemical industry" if their production activities involve the manufacture or processing of "chemical substancers" or "mixtures" as defined by TSCA. TSCA defines chemical substances as including naturally occurring substances such as metals or cotton. Many industrial segments will technically "process" under the definitions of TSCA, and those persons should be subject to the statutory provision for those chemical substances or mixtures which are processed. Persons who solely use (do not process) chemical substances or mixtures may generate section 8(c)-type allegations, which may be sent to and then kept by manufacturers, processors, or distributors of those substances or mixtures: but users are not subject to the section 8(c) recordkeeping and reporting provisions. 2. Since the SIC codes are structured around the article produced by the coded industry, we have drawn inferences about the operations involved in making the end product. Processors were selected by judging whether in some way production of the end product might regularly involve processing of chemicals, such as. at a minimum, applying a surface coating. Thus, while the ' manufacturers of transportation equipment are included on the list, those persons providing transportation services were excluded (SIC 40--48). 3. Industries can be separated into two groups: (a) Group 1. those primarily engaged in manufacturing or processing chemical substances or mixtures, all of whose production employees are expected to be involved in chemical activities, and (b) Group 2, those who may process or distribute chemical substances or mixtures, but only as a small part of their overall operation. Companies in Group 2 may be considered processors or distributors, yet the activities are diverse and chemical processing is expected to be incidental. Therefore, in this review only a portion of the employees were counted to equate their activities with production employees in Group 1. It was estimated that 10% of the employees in Group 2 may be involved in chemical processing during the regular performance of duties. The figure of 10% is very much an estimate of the potential numbers of similarly exposed production workers, and in some cases certain Group 2 industries should have all workers counted (e.g., textile mills). In other cases, fewer than 10% of the production workers should be counted. Given these limitations, the 10% figure can be considered a reasonable estimate which is an easily multiplied figure that commentors can consider and then provide more accurate information. This estimate is for the purposes of analyzing the impact of section 8(c) only, and may not apply to other rules under TSCA. 4. The figures for the numbers of production employees and establishments listed in Appendix B were drawn from data provided by the Bureau of Labor Statistics (BLS). DOL, lEmployment and Wages. First Quarter 197S. PB-292 169,1979). All employees listed in this BLS study are production workers and all establishments and employees are counted only once, according to the primary SIC code. The data are drawn from information submitted to each state unemployment insurance program. BLS considers these data to be a virtual census of all nonagricultural workers. While the data are drawn from January 1975. the figures are more current than the Department of Commerce Census ofManufacturers and most likely approximate the current numbers of establishments and production workers. 5. Due to the structure of the SIC codes, which is based on products not processes, additions to the SIC list were made if it appeared possible that the manufacture of those products might involve processing or handling substances according to the TSCA definitions. Since many of the industries may perform a small amount of related processing, only 10% of those workers are counted. Yet for many large industries, such as automobile manufacturers, the study concluded that 10% may be an overestimate because of the large number of unrelated jobs. Furthermore, counting 100% of the workers in Group 1 . probably is an overestimate. Yet, the figures offer a reasonable approximation of the number of employees with work comparable to that of production employees in the chemical industry, and can serve as the number of workers to be substituted in the formula for estimating section 8(c)-type allegations: ' 47024 Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules Number of allegations from all sources -i-1000 Production Workers Also, the figures for the mining and wholesale trade codes (10-14.50-51} were only available in 3-digit categories, and therefore include some 4-digit categories that would otherwise not be counted in the study (e.g. Mining Services). Results Examination of the Standard Industrial Classification Manual resulted in identifying the following groups: (a) Group 1.100% employee potential exposure Number of SIC codes: 15 3-digit, 55 4-digit Number or establishments: 39,355. Number of production workers: 3,174.951. (b) Group 2.10% employee potential exposure Number of SIC codes: 24 3-digit 308 4-digit Number of establishments: 543,075. Number of production workers: 17.211,586. The following equation estimates the number of U.S. production workers (Section 8(c) Worker Population) involved in chemical activities: Group 1+(Group 2)(0.10)=Section 8(c) Worker Population 3,174,951 +1,721,159=4,895,770 Appendix B--Report Impact Analysis SIC Categories--100% Exposure Group I ' SIC code Description Number of report ed urtits Number of employees 101 Iron Ores.... . ___ ...... 102 Copper Ores___________ ...... 103 Lead & Zinc Ores . . __ 104 Gold Ores A Silver Ore_____ 105 Baurite A Other Aluminum Ores. 106 Ferroalloy Ores, Except Vaoedieum. 109 Miscellaneous Metal Ores...... ill Anlhraralfl ........ 121 Bituminous Coal............. ....... 141 Dimertson Stone__________ 142 Crushed A Broken Strww ... 144 Sand A Gravel 145 Clay, Ceramic and Refractory Minerals. ' 1/7 Chemcal A Fertilizer Minerals. 149 Miscellaneous Nonmetallic Minerals. Except Fuels. 2261 Finishing Plants--Cotton____ 2262 Finishing Plants Man-Made Fiber A Silk. 2269 Finishing Plants Textiles........ 2611 Pulp Mills.............. ............... 2621 Paper Mills. Except Bldg. PapermUs. 2631 Paperboard Mills.................... 264? Paper Coating A Glazing....... 2812 Alkalies and Chlonne___ -- 2813 Industrial Gases..................... 2816 Inorganic Pigments_________ 2819 Industrial Inorganic Chemicals. 2821 PlHsfir Metanata.................. 2822 Synthetic Rubber...... ,, .... 2823 Cellulosic Man-Made Fibers... 2824 Synthetic Organic Fibers, Ex. CeBulosic. 2831 Biological Products.. _ 2833 Medicinal Chemicals............. 2841 Soap A Other Detergents...... 2842 Speciality Cleaning............... 2843 Surface Active Agents. Finishing Agents etc.. 90 144 98 259 18 43 224 146 3.523 265 1,498 2,700 213 202 267 276 315 225 79 433 237 445 73 393 115 735 590 84 30 76 225 125 549 980 198 23,396 43,473 7,969 3453 468 4,596 6.338 3,567 197,452 3,597 40,367 3X107 8,279 24,897 5,067 33,027 29,544 14,502 15.102 173436 6X785 54,527 23.476 17,344 13.713 99.180 83.400 15.239 25.078 93,109 10321 16368 38.371 28.060 6,002 SIC code Description NuratMr of report ed units Number of employees 2844 Perfumes. Cosmetics A 58S Other Toilet Preparations. 2851 Paints A Varnishes______ _ 1,497 2861 Gum A Wood Chemicals____ 139 2865 Cyclic Crudes A Cyclic 208 Intermediates. 2869 Industrial Organic Chemicals. 415 2873 Nitrogenous Fertilizers........... 206 2874 Phosphatic Fertilizers............. 139 2875 Fertilizers, Mixing Only......... 572 2891 Adhesives A Sealants__ ____ 506 2893 Printing Ink........ . 417 2895 Carbon Black............ ...... .... . 33 2699 Cherracals A Chemicals 955 Preparations. 2911 Petroleum Refining.... . 575 2951 Paving Mixtures A Blocks---- 625 2952 Asphalt Felts A Coating........ 215 2992 Lubricating Oils A Greases... 308 2999 Products of Petroleum A 45 Coal NEC.. 3011 Toes A Inner Tubes............... 20T 3021 Rubber A Plastic Footwear -- 102 3031 Reclaimed Rubber......... .... 22 3041 Rubber A Plastic Hose......... 100 3069 Fabricated Rubber................. 1,212 3079 Mtsc. Plastic Products....-.... 7,978 3111 Leather Tanning A Finishing.. 468 3241 Cement, Hydraulic--..... -- 214 3274 Lime.... ........... ............. ......... 106 3312 Blast Furnaces, Steel Works, 468 A Rotting Mitts. 477 3313 Electrometallurgical Products. 58 3331 Primary Smelting A Refining 29 of Copper. 3332 Primary Smelting A Refining 19 at Lead. 3333 Primary Smelting A Refining 15 of Zinc. 3334 Primary Production of 50 Aluminum. 3339 Primary Smelting A Refining 99 of Non-Ferrous Metals NEC.. 3471 Electroplating, Plating A 3.414 Polishing. 3479 Coating Engraving A Allied 1,478 Services. Total........................................ 39,335 47,738 62,861 5.650 33,008 119.231 12.315 15,444 14.160 12,152 12,152 4,361 36,283 155,356 10.225 16.619 8,023 *16 129.086 30,936 767 18,451 107.348 327,331 21,172 32,680 327,331 21,172 507,079 16,999 17,416 3,134 6,424 32362 10396 54,491 28,132 3.T74.951 SIC Categories--10% Exposure Group 11 SIC code Description Number of report ed units Number of employees 131 Crude Petroleum A Natural Gas Liquids. 132 Natural Gas................. ..... .... 2074 Cottonseed Oil Mills............... 2075 Soybean Oil Mills................ 2076 Vegetable Oil Mills_______ -- 2077 Animal A Marine Oil Mills...... 221 Broad Woven Fabric Mills, Cotton. 222 Broad Woven Fabnc Mills. Man-made Fiber A Silk. 223 Broad Woven Fabric Mills, Woofs Including Dying A Finishing. 224 Narrow Fabrics A Other Smaliwares Mills. 225 Women's Full Length A Knee Length Hosiery. 2252 Hosiery, Except Women's Full A Knee Length. 2253 Knit Outerwear Mills.............. 2254 Knit Underwear Milts.............. 6,325 120 ito 78 44 430 427 478 211 449 264 401 1,059 114 145.846 4.262 7.730 9.334 9 99A 11.747 158,286 101.626 21,520 23.199 33,341 2B.897 67.102 32,664 SIC code Deicrution Ntanbar of repori- ad writs Number of amptoyoM 2257 Circular Knit Fabric Mifit____ 378 2258 Warp Knit Fabric MiUa--. 328 2259 Knitting Milts. NEC..--........... 65 2271 Woven Carpets A Pads --. 101 2272 Tufted Carpets A Rugs_____ 407 2279 Carpets A Rugs. NEC 2281 Yam Spinning Mills 2282 Yam Textunzmg_________ -- 2283 Yam Milts. Wool.............. ...... 2284 Thread h6ls............................ 59 401 187 115 79 2291 Fett Goods, except Woven Felts A Hats. 75 2292 Lace Goods__ ____________ 101 2293 Paddngs A Uphotstry Filling.. 127 2294 Processed Waste A Recovered Fiber. 188 2295 Coated Ffeer______________ 2296 Tire Cord A Fiber_____ _____ 2297 Nonwoven Fabncs__ - 191 29 32 2298 Coinage 8 Twin*__________ 170 2299 Textrie Goods. NEC............ 137 2311 Men's A Youth's Suits A 7S4 CoM*. 2321 Men s Nightwear___________ 636 2322 Men's Underwear. 94 2323 Men's Neckwear__________ _ 259 2327 Men's Trousers...................... 658 2328 Men's Work Clothing_______ 471 2329 Clothing, NEC........... .. - 675. 2331 Women's Blouses, Waists A 884 Shirts. 2335 Women's Oresses_________ 4.700 2337 Women's Suits A Skirts__ __ 1,577 2339 Women's NEC........................ 2X92 2341 Women's Underwear--......-- 841 2342 Brassieres A Girdles 322 2351 Millinery----------------------------- 153 2352 Hats A Cape ................... 280 2361 Girts* Dresses, Blouses--...... 475 2363 Girts* Coats A Suits.............. 173 2369 Girls' Outerwear................ --. 432 2371 Fur Goods......................... . 772 2381 Dresses A Work Gloves____ 156 2384 Robes A Dressing Gowns-- 203 2385 RainCoats 260 2386 Leather A Sheep Lined 213 Clothing. 2387 Apparel. Belts...................... . 284 2389 Apparei. NEC.............-- . 219" 2391 Curtains A Draperies- . tXt6 2392 House Furnishings- . . tfiBZ 2393 Textile Bags --___________ 21Q 2394 Canvas A Related Products.. 980 2395 Pleating. Decorative A 999 Novelty Stitching. 2396 Automotive Trimmings -- 636 2397 Schiffii Machine Embro(denes 256 2399 Fabricated Textile Products, 625 NEC 2411 Logging Camps. . 1X655 2421 Sawmills A Planing Mills.____ 7X08 2426 Hardwood Dimension A 665 Flooring Mills. 2429 Special Product Sawmills___ 5T8 2431 Miitwork-- . . . 2.472 2434 Wood Kitchen Cabinets........ 2.470 2435 Hardwood Veneer A Plywood 317 2436 Softwood Veneer A Plywood. 246 2439 Wood Containers____ - - 486 2511 Wood Household Furniture-- 2,058 2512 Wood Household Furniture 1,514 Upholstery. 2514 Metal Household Furniture-- 507 2515 Mattresses A Box Springs-- 1X46 2517 Wood Television. Radio 113 Phonograph A Sewing Machine Cabinets. 2519 Household Furniture NEC__ 146 2521 Wood Office Furniture. 200 2522 Metal Office Furniture...... ..... 208 2531 Public Building A Related 372 Furniture. 2541 Wood Partitions, Shelving, 537 Lockers, etc.. 2542 Metal Partitions A Shelving... 537 2591 Draping Hardware. Window 561 Blinds A Shades. 2599 Furniture A Fixtures NEC___ 262 2642 Envelopes.-............. ............ 260 31X23 20370 4,458 7X61 43,086 946 7X689 18X85 11.488 10.683 2,762 5.726 one 11,198 ft,893 xno 10.440 9.903 92X78 111X49 18.010 6,279 82,552 96.994 50X84 45.742 15X606 56X62 111.144 72:179 34,?ee 2.831 12X20 24,611 7X68 30.162 4,072 1X3B9 7.910 66,038 5X39 8,154 5.324 24,523 37,400 7ifi T2.752 11,854 23,102 2X52 20X92 6X784 158X45 25,060 X713 58.821 3X954 22.308 35.868 8X85 124X07 80X26 27309 31.156 10,948 2X45 11X03 30.159 24.074 26,343 24.709 1X147 9.764 23,457 Federal Register / Vol. 45, No. 135 / Friday, July 11. 1980 / Proposed Rules 47025 S:C code Description Number of report- ed units Number of employees [ SIC code Description Number ot reported units Number of employees 2643 Baps. Except Textile Bags.... 2645 Die^Cui Paper Paperboard & Cardboard. 2546 Pressed A Molded Pulp Goods. 2647 Sanitary Paper Products....... 2648 Stationery. Tablets and Related Products. 2649 Converted Paper and Paperboard NEC.. 2651 Folding Paperboard Boxes. .. 2652 Set-Up Paperboard Boxes.... 2653 Corrugated A Solid Fiber Boxes. 578 423 54 102 88 524 587 340 1.349 46.475 16.869 4.535 19.344 5.707 28.302 41.827 12.916 95.713 2655 Fiber Cans. Tubes. Drums A 299 18.643 Similar Products. 2661 Building Paper A Building 108 11.633 Board Mills. 2711 Newspapers: Publishing. 8.527 382.066 Publishing A Pnnting. 2721 Periodicals. Publishing.......... 2.832 69.081 2731 Books. Publishing A Pnnting.. 1.585 67.643 2732 Book Pnnting.......................... 215 27.681 2741 Misc. Publishing..................... 2.276 38.231 2751 Commercial Pnnting.............. 11.489 164.256 2752 Commercial Pnnting 9.229 168.521 Lithographic. 2753 Engraving A Plate Printing..... 595 1.091 2754 Commercial Printing Gravure. 124 6.350 2879 Pesticides A Agricultural 357 22.027 Chemicals NEC. 3131 Boot A Shoe Cut Stock......... 3142 House Slippers....................... 263 102 9.705 8.994 3143 Men's Footwear..................... 241 3144 Women's Footwear............... 324 59.111 68.434 3149 Footwear, except Rubber 243 22.993 NEC. 3151 Leather Gloves A Mittens...... 108 4.817 3171 Women's Handbags A Purses. 14.176 442 16.926 3172 Personal Leather Goods Ex. Women's Purses. 308 10.835 3199 Leather Goods. NEC......... 405 6.143 3211 Flat Glass........... 3221 Glass Containers 86 18.164 139 69.527 3229 Pressed A Blown Glass......... 327 3231 Glass Products....................... 883 56.500 35.903 3251 Brick A Structural Clay Tile.... 3253 Ceramic Wall A Floor Tile..... 3255 Clay Refractories................... 371 98 157 19.045 6.990 13.579 3259 Structural Clay Products........ 3261 Vitreous China Plumbing Fixtures. 124 80 6.476 6.817 3262 Vitreous China Table and Kitchen Articles. 21 5.341 3263 Fine Earthenware.................. 3264 Porcelain Electrical Supplies.. 12 79 5.124 12.115 3269 Pottery Products NEC........... 3271 Concrete Bnck A Block........ 3272 Concrete Products................. 3273 Ready-Mixed Concrete.......... 3275 Gypsum Products.................. 3281 Cut Slone A Stone Products.. 3291 Abrasive Products................. 3292 Asbestos Products................ 3293 Gaskets. Packing A Sealing.. 3295 Minerals A Earth, Ground...... 3296 Mineral Wools............._......... 3297 Nonctay Refractories............. 3299 Nonmetallic Mineral Products 582 1.388 3.552 4.212 128 937 366 165 382 455 158 98 417 13.370 21.952 66.165 75.900 13.709 12.435 26.318 24.487 25.409 14.449 23,120 11.237 5.711 3315 Steel Wire. Nails.................... 3316 Cold Rolled Steel Sheet Strip A Bars. 192 184 21.250 18.643 3317 Sleei Pipe A Tubes............... 20B 29.414 3321 Grav Iron Foundries.............. 963 3322 Malleable Iron Foundries....... 72 156.225 23.186 3324 Steel Inveslmenl Foundries... 3325 Steel Foundnes NEC............ 3341 Secondary Smelting A Refining pf Nonferrous 58 242 376 11.306 57.309 19.309 Metals. 33SI Rolling. Orawing A Extruding of Copper. 158 30.632 3353 Aluminum Sheet. Plate, A 85 30,350 3354 Aluminum Extruded Products. 3355 Aluminum Rolling A Drawing NEC. 163 24 28.981 5,252 3356 Roiling. Drawing A Extruding 177 of Nonferrous Metals. 3357 Drawing A Insulating of 383 Nonferrous Wire. 3361 Aluminum Foundries.............. 968 3362 Brass. Bronze. Copper. 560 Copper Base Alloy Foundries. 3369 Nonferrous Foundnes NEC.... 425 3398 Metal Heat Treating.............. 449 3399 Primary Metal Products NEC. 237 3411 Metal Cans............................. 421 3412 Metal Shipping Barrels 167 Drums etc. 148 3423 Hand A Edge Tools. Ex. 743 Tools. 3425 Hand Saw A Saw Blades...... 119 3429 Hardware NEC..;.................... 1.073 3431 Enameled Iron Metal Sanitary 133 Ware. 3432 Plumbing Fixture Fittings A 243 Trim. 3433 Heating Equipment Except 379 Electric Warm Air Furnace. 3441 Fabricated Structural Metal.... 2.078 3442 Metal Doors. Sash. Frames. 1.882 etc. 3443 Fabricated Plate Work........... 1,689 3444 Sheet Metal Work.................. 3.696 3446 Architectural A Ornamental 2.000 Metalwork. 3448 Prefabricated Metal Building 448 A Components. 3449 Mtsc. Metal Work................... 333 3451 Screw Machine Products....... 1,881 3452 Bolts. Screws. Rivets A 721 Washers. 3462 Metal Forgings A Stampings.. 497 33 3465 Automotive Stampings........... 294 3469 Metal Stampings NEC............ 3493 Steel Springs Excepl Wire..... 3494 Valves A Pipe Fittings............ 3495 Wire Springs........................... 3496 Misc. Fabricated Wire Products. ' 3497 Metal Foil A Leaf............ ...... 3498 Fabricated Pipe...................... 3499 Fabricated Metal Products, NEC. 3511 Steam. Gas, A Hydraulic Turbines A Generators. 3519 Internal Combustion Engines. 3523 Farm Machinery A Equipment . 3524 Garden Tractors A Garden Equpment 3531 Construction Machinery A Equipment 3532 Mining Machinery A Equipment. 3533 Oil Field Machinery A Equipment. 3534 Elevators A Moving Stairways. 3535 Conveyors A Conveying - 2,260 163 783 258 1.201 48 479 1.236 63 155 1.624 135 701 254 311 167 504 3536 Hoists............................ ....... 3537 industrial Trucks. Tractors. 252 396 3541 Machine Tools. Metal Cutting 3542 Machine Tools. Metal Forming. 3544 Special 0>es A Tools............. 3545 Machine Tool Accessories.... 3546 Power Onven Hard Tools...... 3547 Roiling Mills Machinery A Equipment 3549 Metal Working Machinery NEC. 878 339 7.289 1,661 127 56 199 3551 Food Products Machinery..... 3552 Textile Machinery.................. 3553 Wood Working Machinery..... 3554 Paper Industries Machinery.... 3555 Pnnting Trades Machinery A Equipment 3559 Special industry Machinery. NEC. 751 621 296 211 619 1.051 18.762 82.609 45.656 20.170 16.006 10.911 8.749 69.820 12.237 15,348 49.821 7.655 65,480 9.475 20,417 29.217 106,912 62.464 149.457 84.600 30,665 18.456 9.734 49.076 56.526 55.621 4.661 68.712 5.057 110.631 7.962 92.307 13.646 46.026 2.461 23.912 40.438 49.238 75.792 159.629 20.556 153.975 29.596 57.947 14.647 28.723 28.806 34.383 70.768 28.055 119.176 59.676 22.995 14.469 13.946 43.823 36,176 13.150 18.926 30.315 57.583 SIC code Description Number ol report- ed units Number of employees 3561 Pumps A Pumping 506 Equipment. 3562 Ball A Roller Bearings........... 3563 Air A Gas Compressors........ 3564 Blowers A Exhaust Fans 3565 industnat Patterns........... 3566 Speed Changers A industrial High Speed Dnves. 3567 Industrial Process Furnaces A Ovens. 3568 Mechanical Power Transmission Engines3569 General Ind. Machinery A Eqiapment. 3572 Typewnters.................. ..... .. 3573 Electronic Computing A Equipment 3574 Calculating and Accounting Machines3576 Scales and Balances. Except Laboratory. 3579 Office Machines NEC ....... 163 143 502 966 267 327 160 636 32 738 v, ,, 68 68 199 3561 Automatic Merchandising Macfenes. . 101 3582 Commercial Laundry. A Dry 91 Cleaning. 3585 Air Conditioning A industrial* 658 Commercial Refrigeration Equipment 3586 Measuring and Dispersing 29 Pumps. 3589 Service Industry Machines__ 692 3592 Carburetors. Pistons. Piston 216 Rings, and Valves. 3599 Machinery, excepl Electrical 14.409 NEC. 3612 Power. Distribution. A 383 Specialty Transformers. 3613 Switchgear and Switchboard 568 Apparatus 3621 Motors and Generators.......... 437 623 3623 Welding Apparatus, Electric... 157 3624 Carbon and Graphite 78 Products. 3629 Electrical industrial 148 Apparatus, NEC. 3631 Household Cooking 65 Equipment 3632 Household Refrigerators A 54 Home and Farm Freezers. 3633 Household Laundry Equipment 36 3634 Electric Housewares A Fans.. 3635 Household Vacuum Cleaners 3636 Sewing Machines.................. 3639 Household Appliances NEC... 3641 Electnc Lamps....................... 3643 Current Carrying Wiring 286 32 64 67 251 528 Devices. 3644 Noncurrent Carrying Wiring Devices. 3645 Residential Electric Lighting Fixtures. 3646 Commercial. Industrial. 204 666 191 Institutional Electrical Lighting Fixtures. 3647 Vehicular Lighting Equipment 3646 Lighting Equipment NEC....... 3651 Radio A TV Receiving Sets.-- 3652 Phono Records A Magnetic 50 137 523 624 Tape. 3661 Telephone A Telegraph / Apparatus. 3662 Radio A TV Transmitting Equipment 3671 Radio A TV Receiving Tubes. 3672 Cathode Ray Picture Tubes... 3673 Transmitting. Industrial A 303 1,566 40 67 60 Special Purpose Electron Tubes. 3674 Semiconductors A Related 497 Devices. . 3675 Electronic Capacitors............. 3676 Resistors, for Electronic 102 59 Applications. 3677 Electronic Coils. 274 Transformers, etc. 3676 Connectors, for Electronic Applicators. 36 57.010 59.279 28.714 34.369 10.002 25.113 19.669 24.083 46.211 17.975 219977 31.913 7954 25.448 8.355 5.764 110.564 5.715 31.668 30.947 202.011 59.474 69.954 117.906 62.587 17,528 14.233 11.611 ,, 18.704 34976 20.100 46.188 9.068 6.385 14.793 39.026 73.622 22.382 19.664 15.376 12.603 6994 87.481 22.167 164.121 322.595 12.808 11.966 17913 126.549 19.161 8.344 16994 2343 47026 Federal Register / Vol. 45, No. 135 / Friday, July 11, 1980 / Proposed Rules SICcode Description Number of report ed units Number of employees SIC code Description Number of report ed units Number of employees 3679 Electronic Components NEC . 3691 Storage Battenes.................. . 3692 Primary Battenes, Dry end Wet 3693 X-Ray Equipment..... ............. . 34 Electncat Equipment tor Internet Combustion Engines. 3699 Electrical Equipment NEC.... . 3711 Motor Vehicles and Passenger Car Bodies. 3713 Truck & Bus Bodies.............. 37T4 Motor Vehicle Parts & Accessories. 37t5 Truck Trailers......................... 3721 Aircraft...--.............. _........... 3724 Aircraft Engines..................... 3728 Aircraft Parts........................ .. 3731 Ship Building 6 Repair.......... 3732 Boat Building & Repair......... 3743 Railroad Equipment............... 3754 Motorcycles & Bicycles.......... 3792 Travel Trailers 6 Campers.... 3799 Transportation Equipment..... 3811 Engineering Laboratory. Scientific Equipment 3322 Automatic Controls tor Regulating Commercial 8 Residential Environments. 3824 Totalizing Fluid Meters A Counting Devices. 3825 Instruments for Measuring 8 Testing Electricity 8 Electrical Signals. S329- Measuring 8 Controlling Devices NEC. 3832 Optical Instruments 8 Lenses 2.465 241 72 142 34S 292 334 730 1.719 366 222 246 1.046 456 1,703 145 250 1.02% 363 718 252 134 509 329 416 T4Q.145 25,236 t2.138 T081 82.373 11.663 347.584 45.593 361,418 21.056 305.564 133.864 98.716 165.901 38,401 60,462 1ZJ77 27.820 9.083 65,608 37.823 TS.017 64,062 tr,758 22.495 506 Electrical Goods................... . 23.934 507 Hardware. Plumbing, 8 18.378 Heating Equipment 508 Machinery, Equipment 8 79.375 Supplies. 509 Miscellaneous Durable 22.148 Goods. 511 Paper 8 Paper Goods........... . 8.796 5t3 Apparel. Piece Goods. 8 17.291 Notions. 516 Chemicals 8 Allied Products. . 9,626 517 Petroleum.............................. . 16.885 519 Miscellaneous'Nondurable 33,34r Goods. Total................................. ... 542075 (FR Doc. 80-20490 Piled 7-HW0fft45 am] BILLING CODE 6560-01-M 356.356 206.792 1.002867 193.205 116251 154.027 109:609 225.181 313,787 17.271,586 3841 Surgical 8 Medical Instruments 8 Appliances. 542 3842 Surgical Supplies 8 Appliances. 1,002 3843 Dental Equipment......... 326 3851 Ophthalmic Equipment.......... 933 3861 Photo Equipment 8 Supplies. 682 3873 Watches. Docks. Clockwork 237 8 Supplies. 3911 Jewelry. Precious Metal......... 1.812 3914 Silverware. Plated Ware. 242 Stainless Steel 3915 Jewelers Materials................. 577 3931 Musical Instruments.............. 361 3942 Dolls.................. .. ...... 262 3944 Games. Toys. 8 Children's Vehicles. 696 3949 Sporting and Athletic Goods. 1,547 NEC. 3951 Pens 8 Mechanical Pencils.... ill 3952 Lead Pencils........................... 154 3953 Marking Devices.............. ..... 3955 Carbon Paper 8 Inked 556 103 Ribbons. 3961 Costume Jewelry.............. . 1.341 3962 Feathers, Plumes. Artificial 291 Trees 8 Flowers. 3963 Buttons.............................. 197 3964 Needles. Pins. Hooks, 8 Eyes. 288 3991 Brooms 8. Brushes............ 437 3996 Signs 8 Advertising Displays. 2,662 3995 Bunal Caskets.......-............... 420 3996 Linoleum. Asphalted-FeitBase Roof Covers. 21 3999 Manufacturing Industry.......... 2.158 492 Gas Production 8 Distribution 1.837 SOI Automotive Vehicles 8 27.650 Automotive Equipment. 502 Furniture 8 Home 9.4S5 Furnishings. 503 Lumber 8 Construction 13.484 Materials. 504 Sporting Goods. Toys. 8 5.002 Hobby Goods. 505 Metals 8 Minerals. Except 7,891 Petroleum. 42227 56:178 tS.056 37,617 12&209 32.628 31.315 tt.528 8.826 25.177 6.394 39.178 62.662 9.788 8.285 8340 4.985 28.786 4,926 3.849 16,384 15,899 4tJ62 13.633 8.134 50.145 159.390 367253 85.967 145.810 55.151 126.288 would you like toknow if any changes have been made in certain titles of the CODE OF FEDERAL REGULATIONS without reading the Federal Register every day? If so, you may wish to subscribe totheLSA (List ofCFR Sections Affected), the "Federal Register Index," or both. LSA (List of CFR Sections Affected) $10.00 per year The LSA (List of CFR Sections Affected) is designed to lead users of the Code of Federal Regulations to amendatory actions published in the Federal Register, and is issued monthly in cumulative form. Entries indicate the nature of the changes. Federal Register Index $8.00 per year Indexes covering the contents of the daily Federal Register are issued monthly, quarterly, and annually. Entries are carried primarily under the names of the issuing agencies. Significant subjects are carried as cross-references. A finding aid is included in each publication which lists Federal Register page numbers with the date of publication in the Federal Register. Note to FR Subscribers: FR Indexes and the LSA (List of CFR Sections Affected) will continue to be mailed free of charge to regular FR subscribers. uiirmiiimiiiiiiinMiMiiumiMiiiiiMiuiiiimiiiimimiil Mail order form to: Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 There is enclosed $- . subscription(s) to the publications checked below:. LSA (LIST OF CFR SECTIONS AFFECTEO) ($10.00 a year domestic; $12.50 foreign) FEDERAL REGISTER INDEX ($4.00 a year domestic; $10.00 foreign) 2 Name _____________ Street Address _____ ___ 3 City State ZIP m m Make cheek payable to the Superintendent of Documents . _ SniiiniiimniiiiniiiinrniuniiumiiiiiimiiiiiiiiiimiiiiiiiiiiiimmiiiiMiiiiiiiiiiiS