Toxic Substances Control Act Amendments of 1984

Toxic Substances Control Act Amendments of 1984 - Amends the Toxic Substances Control Act (TSCA) to revise the statements of findings and policy. Refers to the need for more information about toxicity and human and environmental exposure in order to identify and control unreasonable risks presented by chemical substances. Declares that chemical manufacturers and processors have a duty to be informed about toxic effects of such substances and mixtures and to take appropriate actions to prevent exposures that might be harmful to human health or the environment.

Revises definitions to include the designee of the Administrator of the Environmental Protection Agency (EPA) under references to "the Administrator."

Includes any microorganism or other biological substance under the definition of "chemical substance" for purposes of regulation.

Provides that an exclusion for pesticides from TSCA jurisdiction shall not be taken to so exclude exposures to chemical substances which occur during the manufacture of a pesticide.

Includes under the term "standards for the development of test data" a prescription of environmental or human monitoring or other exposure studies for test data for a chemical substance or mixture to be developed and analyzed.

Revises provisions for testing of chemical substances and mixtures to provide that standards also may be prescribed for environmental or human monitoring or other exposure studies. Requires the EPA to periodically establish test methodology guidelines which may be used for development of data prescribed in rules under testing requirements and in testing agreements under provisions (as added by this Act) for testing of large volume chemicals. Directs the Administrator to review, not less than once each five years, the adequacy of the test methodology guidelines and make appropriate revisions. Deletes a requirement for an annual review of the adequacy of the standards for development of test data.

Deletes the maximum limit on the total number of chemical substances and mixtures which may be on a priority list for consideration of testing requirements.

Requires that interagency testing committee meetings relating to the priority list be open to the public and that announcements of such meetings be published at least two weeks in advance. Allows closed meetings to be conducted for administrative and personnel matters.

Requires the committee, in making a priority list recommendation, to identify the chemical properties or effects for which testing is recommended.

Sets forth a presumption that testing for the effects recommended is needed with respect to chemical substances and mixtures added to the priority list by the committee. Requires manufacturers of the listed substances to either individually or collectively submit study plans for the conduct of such testing no later than 180 days from the date of submission of the committee's report to the Administrator. Requires that manufacturers and processors of the listed substances be afforded an opportunity to provide evidence which demonstrates to the Administrator's satisfaction that such testing is not appropriate, in whole or in part. Sets forth relevant factors to be considered by the Administrator. Directs the Administrator to establish certain procedures for such decisions concerning the continued need for such testing. Specifies that the Administrator is not precluded by priority list provisions from making the required findings leading to an EPA rule requiring testing of a substance based upon an independent analysis of the issues involved. Makes specified provisions for exemptions applicable to testing conducted pursuant to priority list provisions.

Adds to the membership of the interagency testing committee one member from the Fish and Wildlife Service and the Consumer Products Safety Commission.

Establishes requirements for the testing of large volume chemicals.

Makes subject to a test rule each chemical substance which is manufactured, processed, sold in, or imported into, the United States in aggregate quantities of 100,000,000 or more pounds per year. Requires each manufacturer of such substance to test it in accordance with specified requirements. Allows designation of other manufacturers or qualified third parties to conduct such tests and submit test data. Sets forth provisions relating to: (1) the effects for which such testing is required; (2) test procedures and guidelines; (3) alternative or innovative test methods and procedures; (4) a listing procedure; (5) generally applicable reporting rules and health and safety study submission rules; (6) test scheduling; (7) exemption and modifications; (8) certification of test results; and (9) inspection and audit.

Adds to prohibited acts: (1) failing or refusing to comply with any requirement for the testing of large volume chemicals; or (2) providing a false or misleading certification under such requirements. Provides that each day after such a false or misleading certification is made shall constitute a separate violation until the day such certification is withdrawn and a complete and accurate substitute certification is filed in its place. Disqualifies any corporation which knows or should have known that its certification is false or misleading from making further certifications under requirements for the testing of large volume chemicals for a five-year period (or a longer period determined by the Administrator after notice and opportunity for a hearing on the record). Provides that the term "person," when used in provisions for prohibited acts and penalties to ensure compliance with such certification requirements, shall include corporate officers and officers of other entities, in their personal as well as official capacities.

Sets forth provisions for negotiated testing agreements.

Authorizes the Administrator to negotiate agreements by which chemical manufacturers or processors will test the substance or mixture, upon EPA determination that adequate test data can be developed more promptly under such an agreement than under a test rule. Requires such agreements to include specified elements described under testing requirement rules.

Requires publication of the text of a proposed agreement, and at least a 60-day period for public comment. Prohibits any such agreement from being based in whole or part on any information or data which has not been placed in a record which is public subject to specified confidentiality provisions. Requires that a reasonable basis for the agreement be provided by that portion of the record which is not confidential. Authorizes modifications of agreements upon petition of any person or the Administrator's own motion.

Provides that such provisions for negotiated agreements do not affect the Administrator's authority to subsequently promulgate an EPA test rule requirement for any chemical substance or mixture which is subject to such an agreement.

Directs the Administrator to promptly promulgate an EPA test rule to require that testing be performed if a person or group fails to conduct the testing agreed upon. Provides that specified findings requirements shall not apply to such promulgation.

Adds provisions for EPA authority for expedited information gathering to support the current expedited review process when the Administrator: (1) has made the requisite finding that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects; and (2) finds that the EPA's ability to initiate appropriate action under specified provisions to prevent or reduce to a sufficient extent such risk or to make a finding that such risk is not unreasonable is limited due to the lack of relevant data. Authorizes the Administrator, under such circumstances, to perform or contract for additional testing and exposure studies which are reasonable and necessary to initiate appropriate action, provided that such activities are initiated within the 180-day expedited review period and the Administrator's action are published within such period. Authorizes the Administrator to seek reimbursement for the costs of such testing and exposure studies from the manufacturers and processors of the substances.

Revises requirements for manufacturing and processing notices for new chemicals and those for which there is a significant new use (the pre-manufacturing notice program or PMN). Replaces references to "a significant new use" of a chemical substance with references to manufacture or processing of a chemical substance in a manner or for "a use which may lead to significant new exposure to human beings or significant new release to the environment."

Authorizes the Administrator to allow a new chemical (or one involving significant new exposure or release) to be manufactured or processed when the PMN program notice review is completed and there has been a determination that specified actions concerning such notice will not be taken by the EPA.

Revises PMN program requirements for submission of test data. Makes it the manufacturer's or processor's duty to submit data which makes a specified demonstration to the satisfaction of the Administrator. (Current law requires the submission of data which the manufacturer or processor believes makes such a showing.)

Revises the required content of PMN program notices to include: (1) specific information and data concerning the substance's physical and chemical properties, associated physical hazards and toxicological properties, and the manner, duration, magnitude, and extent of human exposure or environmental release; and (2) a reasoned evaluation, based on such data and information, of the potential acute and chronic human health effects and adverse environmental effects of the substance under its anticipated conditions of manufacture, processing, distribution in commerce, use and disposal. Requires that such data include certain test data recommended by the Organization for Economic Cooperation and Development, with exceptions under specified conditions.

Revises PMN program provisions for EPA orders prohibiting or limiting manufacture of a chemical substance for which a PMN program notice has been received pending development of information.

Directs the Administrator to notify the manufacturer or processor who submitted the notice of the determinations which underlie such a proposed order. Allows specific objections to the proposed order to be filed, within 30 days after such manufacturer or processor receives such notification, by such manufacturer or processor or by any person who is likely to obtain the chemical substance directly or indirectly from them. Sets forth procedures for consideration of and determinations concerning such objections.

Provides that such orders shall apply to the manufacturer or processor who submitted the notice. Authorizes the Administrator to make such order apply to any other person, whether or not the person was a party to the issuance of the order, who: (1) manufactures the substance for the manufacturer or processor; or (2) processes, distributes in commerce, uses, or disposes of the chemical substance after obtaining it, directly or indirectly, as a chemical substance or as part of a mixture, from such manufacturer or processor. Provides that such order shall not apply to any person who has received a direct notice of the order either from the Administrator or under the following provision. Provides that an order may require any person subject to the order who distributes in commerce the chemical substance, either as a chemical substance or as part of a mixture, to provide a copy of the order to persons to whom the substance is distributed. Provides that any person subject to such an order who complies with its provisions shall be considered in compliance with TSCA with respect to those activities subject to the order.

Makes the exclusive remedy for judicial review of the Administrator's decision to issue such an order after consideration of an objection the commencement by the person who filed the objection of a civil action in the U.S. District Court for the District of Columbia or the U.S. district court for the district of such person's residence or principal place of business. Requires such action to be filed within 60 days after the order becomes effective.

Specifies that PMN program requirements apply to the release in the environment of any genetically engineered microorganism in any quantity for scientific experimentation, analysis, research, or development, whether or not these activities are noncommercial or commercial.

Directs the Administrator, within one year after enactment, to promulgate a list of categories of chemical substances pursuant to PMN program provisions which authorize the EPA listing of chemical substances whose manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment. Requires that such list contain at a minimum certain categories of chemical substances. Sets forth a table describing such categories. Authorizes the Administrator to delete from or refine, by rule, the list of categories set forth in such table, on the basis that the chemical substances thus removed from the list do not meet the requirement of actually or potentially presenting an unreasonable risk through such activities.

Revises provisions for EPA regulation of hazardous chemical substances and mixtures. Deletes a provision that requires the Administrator to use the least burdensome of specified requirements. Expands the scope of such regulation by adding EPA authority to: (1) prohibit the use or disposal of a hazardous chemical substance or mixture; (2) limit the amount of such a substance or mixture which may be used or disposed of; (3) limit the manufacturing, processing, distribution in commerce, use, or disposal of such a substance or mixture, where such activities give rise to release to the environment or human exposure in excess of levels specified by the Administrator in a rule imposing the requirement; (4) require that such substance or mixture or its containers be marked with or accompanied by warning and instructions with respect to its manufacture or processing (in addition to other specified activities); or (5) prohibit or otherwise regulate any manner or method of manufacture, processing, distribution in commerce, use, or disposal of such substance or mixture.

Deletes certain limitations on the Administrator's authority to promulgate rules for such EPA regulation of hazardous chemical substances or mixtures under TSCA. Directs the Administrator, in promulgating such a rule, to make a reasonable attempt to impose the least burdensome requirements consistent with the primary goal of abating unreasonable risk to human health or the environment in a timely manner. Provides that the Administrator's judgment in this regard is discretionary and shall not be overruled in response to a challenge to such requirement except to the extent that it is arbitrary and capricious.

Makes requirements for reporting and retention of information applicable to distributors, users, or disposers of chemical substances (while continuing the current distinction between large and small quantity activities).

Authorizes the Administrator, as an alternative to a specified rule for reporting and retention of information, to require, by written request, any manufacturer, processor, commercial distributor, user, or disposer of a chemical substance to submit information to carry out TSCA. Requires the person involved to provide, within a reasonable time, the requested information insofar as it is known or reasonably ascertainable at the time of the request.

Adds information requirements relating to: (1) amounts of chemical substances or mixtures used or disposed of; (2) impurities resulting from the manufacture, processing, use, or disposal of chemical substances or mixtures; (3) the extent of human exposure; (4) the delivery movement, or holding of chemicals, including the quantity, the date of shipment, and receipt, and the consignor and consignee; and (5) such data as may be reasonably necessary to evaluate the economic consequences of activities undertaken.

Revises reporting and retention of information requirements relating to small quantity activities to add coverage of chemical substances or mixtures: (1) which are subject to a negotiated testing agreement; or (2) where the Administrator has reason to believe that the activities of the small manufacturer, processor, distributor, user or disposer may present an unreasonable risk of injury to human health and the environment and where additional information is needed to ascertain the nature and extent of such risk.

Directs the Administrator to publish a current inventory of chemical substances at least every five years.

Repeals specified provisions for the relationship of TSCA to other Federal laws (including certain provisions involving to filing of reports and waiting periods). Retains provisions for coordination with other Federal laws and provisions specifying TSCA's relationship to the Occupational Safety and Health Act of 1970.

Repeals the general prohibition against TSCA's applicability to chemical substances or mixtures intented solely for export. Includes under export notice requirements chemical substances or mixtures which are subject to a negotiated testing agreement.

Revises provisions for disclosure of data. Grants State authorities the same access to such information as that currently afforded to Federal authorities. Requires that designations of confidentiality for information be: (1) accompanied by statements of justification by the entity submitting the data; and (2) signed by an officer of such entity, with an affirmation that such officer believes such designation is valid. Provides that such confidentiality designations shall remain in effect until the chemical is manufactured. Allows redesignation, at the time manufacturing commences, of data which is believed to be still entitled to confidential treatment. Provides that, except for such provisions relating to the time of manufacture, such confidentiality designations shall remain in effect for three years from the date of such designation, subject to specified provisions. Allows renewals for additional three-year periods. Subjects any person who solicits disclosure or obtains confidential material knowing that its release was unlawful to the same criminal penalties as a person who wrongfully discloses such data.

Directs the Administrator, within one year of enactment of this Act, to submit to the Congress: (1) a report on how TSCA information-gathering authorities have been and could be used to support other chemical regulatory programs; and (2) a report on the relationship between the authorities and requirements under TSCA and the activities of small businesses.