R. A. Libby
Regulations
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Regulations and the Analytical Chemist Starting this month, this column will seek to keep scientists aware of governmental actions affecting analytical chemistry. In addition, information will be provided on how to contact the appropriate governmental agencies so that the views of concerned scientists can help propagate the best possible regulations. We are entering an era where new government regulations, aimed at improving science and its documentation, will have significant scientific and economic effects. Governmental regulations, rules, and guidelines will affect the design of laboratories, the usage of and exposure to certain chemicals, and the conduct and documentation of the analytical chemist's work. Knowledge of both the content of these regulations and the impact of their application will become an important addition to the tools of the analytical chemist. However, even more important will be the participation by
Table
1.
analytical chemists in the formation of regulations that will impact on the analytical discipline The Government's regulation formation process overtly seeks the advice and input of all interested parties. This input is then considered as an agency proposes final regulations. There are several practical problems with this approach. First, proposed regulations ate published in. the Federal Register, a publication not widely read by scientists. Second, the period the agency officially accepts input is usually brief {30-120 days). Thus, scientists who can contribute meaningful inputs into improving the regulations do not usually participate either because they are not aware of the proposed regulations at all, or because they find out about them too late. To remedy this situation, a listing of currently proposed and potential regulations affecting analytical chemistry is shown (see Table I). These and
any subsequent additions will be discussed in future issues in a timely manner to provide analytical chemists
the opportunity to comment in the formative phase of the regulation pro-
Good Laboratory Practices (GLP’s) The forerunner of the growing list of laboratory regulations affecting analytical labor atotiee. i& the Good Laboratory Practices (GLP) regulations proposed by the Food and Drug Administration (FDA) (I). These provide a good example of what a regulation can mean to analytical chemists. The GLP's were proposed because the FDA found deficiencies in safety data submitted to them for review (/), A recent article by Horwitz (2) describes these deficient practices. Although aimed primarily at toxicological laboratories, the GLP’s will also regulate any analytical laboratory' contributing data to nonclinical (meaning
Major Federal Regulatory Agency Proposals Affecting Analytical Chemistry SclarlMe Arc*
Tin*
Toxicological Safety Studies Human Efficacy/ Safety Studies
Biopharma ceutical
Primary Analirtleal Invptvamanl
Statu*
•
Test material characterization; animal lluW/tissue analysis
Proposed in Federal Register 11/19/76, p 51206. Final regulations expected 1978
Test material characterization: human fluid/tissue analysis
Proposed in part in Federal Register 6/27177. p 49612. Further proposals expected
Body llukl/tissue analysis; methods
Proposal expected 1978
development (Pharmacokinetic) E
nvironmenta 1/Toxicology Efficacy/ Studies
Proposed In part in Federal Register 7110/78, p 29696. Comments deadline 9/t8/7B
Test material characterization; residue analysis
Human and Environmental
Method development (trace levels)
Human and Environmental
Regulation of hazardous chemicals. Affect facility design; exposure to and how, or If. chemicals can
Proposal expected 1976
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Proposed regulations in Federal Register 10/4/77, p 54148. Final regulations possible late 1978 Proposed in Federal Register 6/13/76, p 25658. Comments deadline
10/11/78
Revised policy possible in ‘
Fw infer mason on any rr0utalnjn» pvpowd •> tta FsOtni RegtsWf. me federal agtnaei Ktemfflod may be confected to- cottas C proposals
ANALYTICAL CHEMISTRY. VOL. 50, NO. 11, SEPTEMBER 1978
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nonhuman) safety tests of FDA-regulated articles submitted to or used by the FDA. Such analytical data include qualitative and quantitative characterization of the material being tested, animal feed and water quality control, metabolism studies, and data on the level, homogeneity, and rate of release of the test material in any mixtures administered to animals. No exemptions are provided for hospital, university, or medical school analytical laboratories providing information of this type. The GLP’s require extensive written records describing the qualification of the personnel, the analytical methodology used, historical records of revisions of this methodology, preparation and expiration dating of all reagents and chemicals, instrument calibration, maintenance, and occurrence of malfunctions, and explanations for changes in raw data. A limited access archives for the storage of all raw data is required. In addition, an internal Quality Assurance Unit, a new organizational requirement for most laboratories, must verify that the regulations are being followed. Internal audit reports from this unit detailing infractions must be maintained for possible availability to the FDA. In addition, the GLP’s provide for periodic on-site
inspection by the FDA to confirm GLP compliance. The agency inspection report would be made available to the public. The GLP’s should have attracted the widespread attention of the country’s analytical community. This did not occur; rather, many scientists, particularly those in the academic community, had no idea as to what these regulations contained. Of the total response of close to 200 interested parties, both oral or written, only 24 people represented the entire academic sector. None of those responding was an analytical chemist. Although the formal period for written comments to the FDA on its GLP proposal is past, the agency has not finalized its ideas nor published a revised final proposal. Until it does, supplemental
still be sent to the agency identified as: RE: Docket 76N-0400/Proposed Good Laboratory comments may
Practice Regulations. Comments should be sent to:
Hearing Clerk (HFC-20) Food and Drug Administration 5600 Fisher Lane, Room 4-65 Rockville, Md. 02857
Beyond GLP's That the regulatory area is growing is shown by Table I, and it is important to realize that the GLP concept is not limited to drug studies or the FDA. The FDA (/) indicates that the GLP’s may be adopted by other Federal Agencies as laboratory standards for materials they regulate, as well as for judging the acceptability of laboratories that are grant applicants or contract FDA bidders. FDA is already in-
specting laboratories for the Environmental Protection Agency (EPA) and a governmental interagency group of FDA, EPA, Consumer Product Safety Commission (CPSC), and Occupational Safety and Health Administration (OSHA) personnel are addressing broadscale adoption of GLP princi-
References
The Federal Register is abstracted, and the abstracts are published by
Can You Imagine Your Sample Giving This Type of Stable Profile ?
Chemical Abstracts. However, most of the articles deal with foods, drugs, water, pesticides, etc., and they are published in the appropriate subject sections, rather than in the analytical chemistry section.
(1) Fed. Regist., 41 (225), 51206-30 (19 Nov. 1976). (2) William Horwitz, Anal. Chem., 50 (6), 521A (1978).
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