§ 79.60 Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

(a) General Provisions—(1) Scope. (i) This section prescribes good laboratory practices (GLPs) for conducting inhalation exposure studies relating to motor vehicle emissions health effects testing under this part. These directions are intended to ensure the quality and integrity of health effects data submitted pursuant to registration regulations issued under sections 211(b) or 211(e) of the Clean Air Act (CAA) (42 U.S.C. 7545).

(ii) This section applies to any study described by paragraph (a)(1)(i) of this section which any person conducts, initiates, or supports on or after May 27, 1994.

(iii) It is EPA's policy that all health effects data developed under sections 211(b) and (e) of CAA be in accordance with provisions of this section. If data are not developed in accordance with the provisions of this section, EPA may consider such data insufficient to evaluate the health effects of a motor vehicle's fuel or fuel additive emissions, unless the submitter provides additional information demonstrating that the data are reliable and adequate and EPA determines that the data are sufficient.

(2) Definitions. As used in this section, the following terms shall have the meanings specified:

Batch means a specific quantity or lot of a test fuel, additive/base fuel mixture, or reference substance that has been characterized according to § 79.60(f)(1)(i).

CAA means the Clean Air Act.

Carrier means any material which is combined with engine/motor vehicle emissions or a reference substance for administration to a test system. “Carrier” includes, but is not limited to, clean, filtered air, water, feed, and nutrient media.

Control atmosphere means clean, filtered air which is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test atmosphere for chemical or biological measurements.

Experimental start date means the first date the test atmosphere is applied to the test system.

Experimental termination date means the last date on which data are collected directly from the study.

Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.

Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies.

Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. “Raw data” may include photographs, videotape, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

Reference substance means any chemical substance or mixture, analytical standard, or material other than engine/motor vehicle emissions and/or its carrier, that is administered to or used in analyzing the test system in the course of a study. A “reference substance” is used to establish a basis for comparison with the test atmosphere for known chemical or biological measurements, i.e., positive or negative control substance.

Specimen means any material derived from a test system for examination or analysis.

Sponsor means person who initiates and supports, by provision of financial or other resources, a study or a person who submits a study to EPA in response to the CAA Section 211(b) or 211(e) Fuels and Fuel Additives Registration Rule or a testing facility, if it both initiates and actually conducts the study.

Study means any experiment, at one or more test sites, in which a test system is exposed to a test atmosphere under laboratory conditions to determine or help predict the health effects of that exposure in humans, other living organisms, or media.

Study completion date means the date the final report is signed by the study director.

Study director means the individual responsible for the overall conduct of a study.

Study initiation date means the date the protocol is signed by the study director.

Test substance means a vapor and/or aerosol mixture composed of engine/motor vehicle emissions and clean, filtered air which is administered directly, or indirectly, by the inhalation route to a test system in a study which develops data to meet the registration requirements of CAA section 211(b) or (e).

Test system means any animal, microorganism, chemical or physical matrix, to which the test, control, or reference substance is administered or added for study. This definition also includes appropriate groups or components of the system not treated with the test, control, or reference substance.

Testing facility means a person who actually conducts a study, i.e., actually uses the test substance in a test system. “Testing facility” encompasses only those operational units that are being or have been used to conduct studies.

TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).

(3) Applicability to studies performed under grants and contracts. When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this section applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study that must be conducted in compliance with the provisions of this section.

(4) Statement of compliance or non-compliance. Any person who submits to EPA a test in compliance with registration regulations issued under CAA section 211(b) or section 211(e) shall include in the submission a true and correct statement, signed by the sponsor and the study director, of one of the following types:

(i) A statement that the study was conducted in accordance with this section; or

(ii) A statement describing in detail all differences between the practices used in the study and those required by this section; or

(iii) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this section.

(5) Inspection of a testing facility. (i) A testing facility shall permit an authorized employee or duly designated representative of EPA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this section applies. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except the EPA may seek production of these records in litigation or formal adjudicatory hearings.

(ii) EPA will not consider reliable for purposes of showing that a test substance does or does not present a risk of injury to health or the environment any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this section. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of any obligation under any applicable statute or regulation to submit the results of the study to EPA.

(6) Effects of non-compliance. (i) Pursuant to sections 114, 208, and 211(d) of the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart F) if:

(A) The test is not being or was not conducted in accordance with any requirement of this part; or