Receipt test substances

The movement of the test substance during the course of a Held residue study must be tracked to assure that the integrity of the test substance is maintained [40 CFR 160.185(a)(10)]. The COC can be accomplished in a number of ways. In the simplest situation, every person signs their name on a piece of paper that accompanies the test substance when they handle the test substance. Eventually the COC will list the names of all those who handled the test substance during the course of the study. Shipment, receipt, weighing, and final disposition of the test substance container must all be tracked and promptly recorded if an unbroken COC is to be present at the end of the trial. The completed COC becomes an essential part of the field residue trial record. 

The date of test substance shipment, lot number, date of receipt and method of shipment, and also the amount and container size, should be documented. The test substance should be stored in the appropriate manner and under the correct storage conditions. 

Receipt and storage of test substances and reference substances... 

The receipt of the test substance should be documented upon arrival at the test site. The name of the product, manufacturer, active ingredient concentration, expiration date, storage location, storage requirements, lot or batch number, the amount received, the condition at receipt, and whether the material is an emulsifiable concentrate (EC), fiowable, powder or otherwise should be noted in the research notebook. In addition, one should note the purchase date, the shipment date, and the carrier of the product. 

Chain-of-custody procedures for test substances or mixtures -including procedures for receipt, storage and distribution... 

For example, the requirements for tracking the receipt and use of the test substances and test animals are the same. The need for the calibration of the test equipment, storage, and archives are the same. 

Under 5(e), following receipt and review of a PMN EPA may order a company to develop test data "sufficient to evaluate the health and environmental effects" of the new substance. However, if the PMN submitter objects to the order (and provides sufficient grounds for that objection), the order does not take effect and EPA must obtain an injunction from a U.S. district court to impose the data requirements (and any appropriate production or use restrictions). 

Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances. 

Under the TSCA, a new chemical is a chemical substance that is not already included on the TSCA Inventory, and is intended to be used for a commercial purpose (other than as a drug or pesticide) in the USA. Section 5 of the TSCA requires manufacturers or importers of a new chemical to notify the EPA (i.e., submit a premanufacture notification, PMN) before manufacturing or importing the chemical. The EPA has only 90 days (extendable to 180 days under certain circumstances) from the time of receipt of the notification to determine if an unreasonable risk may or will be presented by any aspect of the new industrial chemical, and make risk management decisions and take action to control any unreasonable risks posed by the chemical [17]. If after 90 days the submitter of a new chemical is not notified by the EPA of any regulatory restrictions or test requirements, they can legally market or import the chemical. 

Where necessary, the date of receipt of any substance used fortesting operations (e.g., reagents and reference standards) should be indicated on the container. Instructions for use and storage should be followed. In certain cases it may be necessary to carry out an identification test and/or other testing of reagent materials upon receipt or before use. 

Upon the receipt of any test data pursuant to a rule under subsection (a) of this section, the Administrator shall pubHsh a notice of the receipt of such data in the Federal Register within 15 days of its receipt. Subject to section 2613 of this title, each such notice shall (1) identify the chemical substance or mixture for which data have been received (2) list the uses or intended uses of such substance or mixture and the information required by the appHcable standards for the development of test data and (3) describe the nature of the test data developed. Except as otherwise provided in section 2613 of this title, such data shall be made available by the Administrator for examination by any person. 

C) in the case of the receipt of data under subsection (b) of this section, describes the nature of the tests performed on such substance and any data which was developed pursuant to subsection (b) of this section or a rule under section 2603 of this title. 

Question 2 May an employer allow a driver, subject to post-accident controlled substances testing, to continue to drive pending receipt of the results of the controlled substances test ... 

GLPs require that there are separate areas for test, reference, and control substance receipt and storage, mixing with carrier, and storage of the mixtures. Test, reference and control substances are typically supplied by the sponsor and shipped directly to the field sites to be stored under label conditions. A computerized temperature and relative humidity monitoring device can be packaged with the test chemical prior to shipment, then down-loaded upon arrival to assure that the chemical was not subjected to conditions outside its stability range. 

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