ML20149M190
| ML20149M190 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/1988 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-53FR2853, RULE-PRM-31-4 PR-880127, NUDOCS 8802250397 | |
| Download: ML20149M190 (5) | |
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[759q Q.n NUCLEAR REGULATORY CCMMISSION 10 CFR Part 31
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[ Docket No. PRM-31-4]
,.n,y GENE-TRAK Systems; Filing of Petition for Rulemaki
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AGENCY:
Nuclear Regulatory Comission.
ACTION: Notice of receipt of petition for rulemaking from GENE-TRAX Systems.
SUMMARY
The Comission is publishing for public coment this notice of receipt of a petition for rulemaking dated November 18, 1987, which was filed with the Comission by GENE-TRAK Systems.
The petition has been assigned Docket No. PRM-31-4. The petition requests that the Comission establish that 100 microcuries of phosphorus-32 used in GENE-TRAK Salmonella and Listeria assays by a food laboratory is an exempt quantity under a general license according to 31.11.
DATE:
Submit coments by (60 days after publication in the Federal Register).
Coments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to coments received on or before this date.
ADDRESSES: All persons who desire to submit written cements concerning the petition for rulemaking should serd their coments to the Secretary of the Comissien, U.S. Nuclear Regulatory Comission, Washington, DC 20555, k
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Docketing and Service Branch, oy '
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8802250397 880127
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.. For a copy of the petition, write the Division of Rules and Recoros, Office of Administration and Resources Management, U.S. Nuclear Regulatory Comission, Washington, DC 20555.
The petition and copies of coments may be inspected and copied for a fee at the NRC Public Document Room, 1717 H Street, NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT:
David L. Meyer, Chief, Rules and Procedures Branch, Division of Rules and Records, Office of Administration and Resources Management, U.S. Nuclear Regulatory Comission, Washington, DC 20555, Telephone: 301-492-7086 or Toll Free: 800-368-5642.
SUPPLEMENTARY INFORMATION:
Background
The food industry and its regulators are continuously concerned with the transmission of disease producing organisms, or pathogens, through processed food products.
Food laboratories throughout the country routinely test food products for the presence of pathogens such as Salmonella and Listeria.
Salmonella, an important cause of food transmitted illness, is widely distributed in nature.
There are approximately 2,000 different Salmonella organisms all potentially harmful to humans.
Because of the widespread nature of Salmonella in the environrer.t. there is the possibility that food products
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3 may be contaminated after processing. Therefore, many food manufacturers routinely test finished products for the presence of Salmonella.
Listeria is an emerging pathogen of special significance.
In contrast to common food poisoning agents which generally cause gastrointestinal disease, Listeria infection can produce severe disorders such as meningitis, septicemia, and abortion.
Listeria, which is ubiquitous in nature and is able to survive and multiply at refrigeration temperature, is a contamine.nt most likely to be found in foods of animal origin. The presence of species of Listeria may be significant indicators of food plant sanitation conditions.
The Petitioner GENE-TRAX Systems is a joint venture forced between Integrated G9netics, Inc., Framingham, Massachusetts and AMOCO Corporation of Chicago, Illinois.
The company currently markets and sells in-vitro diagnostic tests for food bacteria such as Salmonella and Listeria in food products.
GENE-TRAK Systems has applied new technology to improve on conventional microbiological methods of identifying these pathogens.
The Process Because of new advances in molecular biology, it is now possible to isolate DNA from the bacteria te be tested for, label it with phosphorus-32, a J
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. radioactive isotope, and use it in a test system to identify the bacteria if it is present in food samples.
The petitioner has developed test procedures using DNA probes for both Salmonella and Listeria.
The petitioner asserts that these tests are more accurate because the DNA probes are highly specific.
In addition, the tests are speedier, requiring only two days for completion rather than the seven days needed for conventional methods.
The Problem Because of the presence of byproduct material in the form of phosphorus-32 in amounts exceeding currently exempt quantities, those desiring to use the DNA probe assays must apply for and obtain a specific license from the NRC that authorizes the use. The amount of phosphorus-32 used per test is 0.5 microcurie and the amount shipped in a single vial is 75 microcuries.
The assays are in-vitro diagnostic tests conducted in food laboratories.
The Solution The petitioner requests that NRC amend 431.11(a) to include food laboratories and to include up to 100 micorcuries of phosphorus-32 as an exempt quantity, i
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. The petitioner asserts that authorizing the use of these products under a general license would assist food manufacturers and food laboratories by eliminating the licensing procedure.
In addition, the paperwork burden on both the NRC and the industry would be reduced.
Dated at Washington, DC this % h ay of January 1988.
For the Nuclear Regulatory Comission.
Ch CWs
/ Samuel J.
ik, Secretary f the Comission.
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