1990.152 Model emergency temporary standard pursuant to section 6(c) of the Act. AUTHORITY: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 8-76 (41 FR 25059); and 29 CFR part 1911.

SOURCE: 45 FR 5282, Jan. 22, 1980, unless otherwise noted.

GENERAL

§ 1990.101 Scope.

This part establishes criteria and procedures for the identification, classification, and regulation of potential occupational carcinogens found in each workplace in the United States regulated by the Occupational Safety and Health Act of 1970 (the Act). The procedures contained in this part supplement the procedural regulations in other parts of this chapter. In the event of a conflict, the procedures contained in this part shall govern the identification, classification, and regulation of potential occupational carcinogens. This part may be referred to as "The OSHA Cancer Policy."

§ 1990.102 Purpose.

The Act provides, among other things, that

the Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this section, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his or her working life. Development of standards under this section shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired (section 6(b)(5)).

It is the purpose of the regulations of this part to carry out the intent of the Act with respect to the identification,

classification, and regulation of potential occupational carcinogens.

§ 1990.103 Definitions.

Terms used in this part shall have the meanings set forth in the Act. In addition, as used in this part, the following terms shall have the meanings set forth below:

Act means the Occupational Safety and Health Act of 1970 (Pub. L. 91-596, 84 Stat. 1590 et seq., 29 U.S.C. 551 et seq.).

Administrator of EPA means the Administrator of the United States Environmental Protection Agency, or designee.

Chairperson of CPSC means the Chairman of the United States Consumer Product Safety Commission, or designee.

Commissioner of FDA means the Commissioner of the Food and Drug Administration, United States Department of Health and Human Services, or designee.

Director of NCI means the Director of the National Cancer Institute, United States Department of Health and Human Services, or designee.

Director of NIEHS means the Director of the National Institute of Environmental Health Sciences, United States Department of Health and Human Services, or designee.

Director of NIOSH means the Director of the National Institute for Occupational Safety and Health, United States Department of Health and Human Services, or designee.

Mutagenesis means the induction of heritable changes in the genetic material of either somatic or germinal cells.

Positive results in short-term tests means positive results in assays for two or more of the following types of effect:

(1) The induction of DNA damage and/or repair;

(2) Mutagenesis in bacteria, yeast, Neurospora or Drosophila melanogaster; (3) Mutagenesis in mammalian somatic cells;

(4) Mutagenesis in mammalian germinal cells; or

(5) Neoplastic transformation mammalian cells in culture.

of

Potential occupational carcinogen means any substance, or combination or mixture of substances, which causes

an increased incidence of benign and/or malignant neoplasms, or a substantial decrease in the latency period between exposure and onset of neoplasms in humans or in one or more experimental mammalian species as the result of any oral, respiratory or dermal exposure, or any other exposure which results in the induction of tumors at a site other than the site of administration. This definition also includes any substance which is metabolized into one or more potential occupational carcinogens by mammals.

Secretary of HHS means the Secretary of the United States Department of Health and Human Services, or designee.

§ 1990.104 Scientific review panel.

(a) General. At any time, the Secretary may request the Director of NCI, the Director of NIEHS and/or the Director of NIOSH to convene a scientific review panel ("the panel") to provide recommendations to the Secretary in the identification, classification, or regulation of any potential occupational carcinogen.

(b) Membership. The panel will consist of individuals chosen by the respective Director(s). The panel will consist of individuals who are appropriately qualified in the disciplines relevant to the issues to be considered, and who are employed by the United States. The panel does not constitute an advisory committee within the meaning of section 6(b) or 7(b) of the Act, or the Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770).

(c) Report. The Secretary shall request that the panel submit a report of its evaluation within ninety (90) days after the appointment of the members of the panel. The Secretary shall place a copy of the report in the record of any relevant rulemaking undertaken pursuant to this part and allow an appropriate time for public review and comment. If a panel is not established or fails to file a timely report, or if the Secretary determines that it is necessary to proceed without waiting for the panel's report, the Secretary may proceed in making any determination without such report.

(d) Other aid and assistance. Nothing herein precludes the Secretary from

obtaining advice or other aid from any person or organization including NCI, NIEHS, and NIOSH.

§ 1990.105 Advisory committees.

The Secretary may appoint an Advisory Committee, pursuant to sections 6(b) and 7 of the Act, and 29 CFR part 1912, concerning any potential occupational carcinogen. The Secretary shall require the Advisory Committee to submit its recommendations to assist the Secretary in standard setting no later than ninety (90) days from the date of the Advisory Committee's appointment, unless extended by the Secretary for exceptional circumstances. If an Advisory Committee fails to file a timely report, the Secretary may proceed in standard setting activities without such a report.

§ 1990.106 Amendments to this policy.

(a) Initiation of review of this policy— (1) Secretary's request. No later than every three (3) years from the effective date of this part, or from the last general review, the Secretary shall request the Director of NCI, the Director of NIEHS and/or the Director of NIOSH, to review this part and render their opinions on whether significant scientific or technical advances made since the effective date of this part warrant any amendment to this part. The request shall ask that the answer be provided to the Secretary within one hundred twenty (120) days.

(2) Recommendations by the institutes. At any time, the Director of NCI, the Director of NIEHS and/or the Director of NIOSH may submit recommendations to the Secretary for amendments to this part whenever any of them believes that scientific or technical advances justify such amendments.

(3) Petitions from the public. (i) Any interested person may petition the Secretary concerning amendments to this part based upon substantial new issues or substantial new evidence.

(ii) For the purposes of this part, substantial new evidence is evidence which differs significantly from that presented in establishing this part, including amendments.

(iii) For the purposes of this part, substantial new issues are issues which differ significantly from those upon

which the Secretary has reached a conclusion in the rulemaking establishing this part (including the conclusions reached in the preamble).

(iv) Each petition to amend this part shall contain at least the following information:

(A) Name and address of petitioner; (B) The provisions which the petitioner believes are inappropriate;

(C) All data, views and arguments relied upon by the petitioner; and

(D) A detailed statement and analysis as to why the petitioner believes that the data, views and arguments presented by petitioner:

(1) Constitute substantial new issues or substantial new evidence; and

(2) Are so significant as to warrant amendment of this part.

(b) Response to recommendations and petitions—(1) By the institutes. Whenever any Director recommends an amendment to this part, the Secretary shall, within one hundred twenty (120) days after receipt of the recommendation, publish in the FEDERAL REGISTER, a notice which:

(i) States the reasons why the Secretary has determined not to commence a rulemaking proceeding to amend this part, in whole or in part, at that time; or

(ii) Commences a rulemaking proceeding to consider amending this part accordingly; or

(iii) Appoints an Advisory Committee as provided for by § 1990.105 of this part and sections 6(b) and 7 of the Act.

(2) By the public. Within ninety (90) days, or as soon thereafter as possible, after receipt of a petition pursuant to § 1990.106(a)(3), the Secretary shall:

(i) Refer the petition to the Director of NCI, the Director of NIEHS and/or the Director of NIOSH, in which case the provisions of §1990.106 (a)(1) and (b)(1) are applicable; or

(ii) Appoint an advisory committee; (iii) Deny the petition, briefly giving the reasons therefor; or

(iv) Commence a rulemaking proceeding to consider amending this part accordingly.

(3) On the Secretary's motion. At any time, the Secretary may, on his own

motion, commence a rulemaking proceeding to amend this part.

[45 FR 5282, Jan. 22, 1980; 45 FR 43405, June 27, 1980]

THE OSHA CANCER POLICY

§ 1990.111 General statement of regulatory policy.

(a) This part establishes the criteria and procedures under which substances will be regulated by OSHA as potential occupational carcinogens. Although the conclusive identification of "carcinogens" is a complex matter "on the frontiers of science," (IUD v. Hodgson 499 F. 2d 467, 474 (D.C. Cir. 1974)), responsible health regulatory policy requires that criteria should be specified for the identification of substances which should be regulated as posing potential cancer risks to workers.

(b) The criteria established by this part are based on an extensive review of scientific data and opinions. The part provides for amending these criteria in light of new scientific developments. Decisions as to whether any particular substance meets the criteria or not will be consistent with the policies and procedures established by this part and will be based upon scientific evaluation of the evidence on that substance.

(c) This part applies to individual substances, groups of substances, or combinations or mixtures of substances which may be found in workplaces in the United States. In individual rulemaking proceedings under this part, the identity and range of substances and mixtures to be covered by the standard will be specified and the appropriateness of applying the available evidence to the range of substances and mixtures proposed for regulation will be subject to scientific and policy review.

(d) Potential occupational carcinogens will be identified and classified on the basis of human epidemiological studies and/or experimental carcinogenesis bioassays in mammals. Positive results in short term tests will also be used as concordant evidence.

(e) Potential occupational carcinogens will be classified and regulated in

accordance with the policy. The scientific evidence as to whether individual substances meet these criteria will be considered in individual rulemakings. The issues which may be considered in these rulemakings will be limited as specified herein.

(f) This policy provides for the classification of potential occupational carcinogens into two categories depending on the nature and extent of the available scientific evidence. The two categories of potential occupational carcinogens may be regulated differently.

(g) The policy establishes a procedure for setting priorities and making them public.

(h) Worker exposure to Category I Potential Carcinogens will be reduced primarily through the use of engineering and work practice controls.

(i) Worker exposure to Category II Potential Carcinogens will be reduced as appropriate and consistent with the statutory requirements on a case-bycase basis in the rulemaking proceedings on individual substances. Any permissible exposure level so established shall be met primarily through engineering and work practice controls.

(j) The assessment of cancer risk to workers resulting from exposure to a potential occupational carcinogen will be made on the basis of available data. Because of the uncertainties and serious consequences to workers if the estimated risk is understated, cautious and prudent assumptions will be utilized to perform risk assessments.

(k) Where the Secretary determines that one or more suitable substitutes exist for certain uses of Category I Potential Carcinogens that are less hazardous to humans, a no occupational exposure level shall be set for those uses, to be achieved solely through the use of engineering and work practice controls to encourage substitution. In determining whether a substitute is suitable, the Secretary will consider the technological and economic feasibility of the introduction of the substitute, including its relative effectiveness and other relevant factors, such as regulatory requirements and the time needed for an orderly transition to the substitute.

[45 FR 5282, Jan. 22, 1980, as amended at 46 FR 5881, Jan. 21, 1981]

§ 1990.112 Classification of potential carcinogens.

The following criteria for identification, classification and regulation of potential occupational carcinogens will be applied, unless the Secretary considers evidence under the provisions of §§ 1990.143, 1990.144 and 1990.145 and determines that such evidence warrants an exception to these criteria.

(a) Category I Potential Carcinogens. A substance shall be identified, classified, and regulated as a Category I Potential Carcinogen if, upon scientific evaluation, the Secretary determines that the substance meets the definition of a potential occupational carcinogen in (1) humans, or (2) in a single mammalian species in a long-term bioassay where the results are in concordance with some other scientifically evaluated evidence of a potential carcinogenic hazard, or (3) in a single mammalian species in an adequately conducted longterm bioassay, in appropriate circumstances where the Secretary determines the requirement for concordance is not necessary. Evidence of concordance is any of the following: positive results from independent testing in the same or other species, positive results in short-term tests, or induction of tumors at injection or implantation

sites.

(b) Category II Potential Carcinogens. A substance shall be identified, classified, and regulated as a Category II Potential Carcinogen if, upon scientific evaluation, the Secretary determines that:

(1) The substance meets the criteria set forth in §1990.112(a), but the evidence is found by the Secretary to be only "suggestive"; or

(2) The substance meets the criteria set forth in §1990.112(a) in a single mammalian species without evidence of concordance.

PRIORITY SETTING

§ 1990.121 Candidate list of potential occupational carcinogens.

(a) Contents. The Secretary shall prepare a list of substances (the "Candidate List”) which are reported to be present in any American workplace and which, on the basis of a brief scientific review of available data, may be

considered candidates for further scientific review and possible regulation as Category I Potential Carcinogens or Category II Potential Carcinogens. For the purposes of this paragraph, “available data" means:

(1) The data submitted by any person;

(2) Any data referred to by the Secretary of HHS or by the Director of NIOSH, either in the latest list entitled "Suspected Carcinogens" or any other communication;

(3) Literature referred to in U.S. Public Health Service, Publication No. 149; (4) Data summarized and reviewed in Monographs of the International Agency for Research on Cancer (IARC) of the World Health Organization;

(5) The Toxic Substances Control Act Inventory of Chemical of Chemical Substances, published by the Administrator of EPA;

(6) The Secretary of HHS's Annual Report to the President and the Congress as required by the Community Mental Health Centers Extension Act of 1978, section 404(a)(9), 42 U.S.C. 285. (7) Any other relevant data of which the Secretary has actual knowledge.

(b) Tentative classification. The Secretary may tentatively designate substances on the Candidate List as candidates for classification as Category I Potential Carcinogens or as Category II Potential Carcinogens, or may list substances without a tentative designation, based on the brief scientific review of available data for the purpose of initiating a more extensive scientific review.

(c) Nú legal rights established. The inclusion or exclusion of any substance from the Candidate List shall not be subject to judicial review nor be the basis of any legal action, nor shall the exclusion of any substance from the list prevent the regulation of that substance as a potential occupational carcinogen. The inclusion of a substance on the Candidate List and its possible tentative designation as a Category I Potential Carcinogen or a Category II Potential Carcinogen therein do not reflect a final scientific determination that the substance is, in fact, a Category I Potential Carcinogen or a Category II Potential Carcinogen. It is a policy determination based on the brief

scientific review that the Secretary should conduct a thorough review of all relevant scientific data concerning the substance.

EFFECTIVE DATE NOTE: Paragraphs (a) and (b) of § 1990.121 were stayed at 48 FR 243, Jan. 4, 1983, in order to evaluate the impact of publishing the Candidate Lists and Priority List and to reconsider the criteria used in establishing the lists (see also 47 FR 187, Jan. 5, 1982).

§ 1990.122 Response to petitions.

Whenever the Secretary receives any information submitted in writing by any interested person concerning the inclusion or omission of any substance from the Candidate List, the Secretary shall briefly review the information and any other available data, as defined in §1990.121(a). The results of the Secretary's review shall be transmitted to the petitioner, together with a short statement of the Secretary's reasons therefor, and made public upon request.

EFFECTIVE DATE NOTE: Section 1990.122 was stayed at 48 FR 243, Jan. 4, 1983, in order to evaluate the impact of publishing the Candidate List and Priority Lists and to reconsider the criteria used in establishing the lists (see also 47 FR 187, Jan. 5, 1982).

§ 1990.131 Priority lists for regulating potential occupational carcinogens.

The Secretary shall establish two priority lists for regulating potential occupational carcinogens. One list should include approximately ten (10) candidates for rulemaking as Category I Potential Carcinogens; the other approximately ten (10) candidates for rulemaking as Category II Potential Carcinogens. The order of placement of substances on these lists will not reflect the Secretary's determination of the exact order in which these substances should be regulated in rulemaking proceedings but rather a policy determination that the Secretary plans to address some or all of these substances prior to proceeding with a thorough scientific review of data concerning other substances on the Candidate List. The inclusion or exclusion of any substance on these lists shall not be subject to judicial review or be