Fda cfr21 part 113 new termomether regulations

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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations
5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2070. SUPPLEMENTARY INFORMATION: Table of Contents
I. Background II. Comments on the Proposed Rule III. Minor Revisions in Regulations IV. Analysis of Economic Impacts A. Final Regulatory Impact Analysis B. Regulatory Flexibility Analysis C.Unfunded Mandate Analysis V. Paperwork Reduction Act of 1995 VI. Federalism VII. References

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 113
[Docket No. FDA–2007–N–0265; Formerly Docket No. 2007P–0026]

Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
AGENCY:

Food and Drug Administration,

HHS.ACTION:

Final rule.

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The Food and Drug Administration (FDA) is amending its regulations for thermally processed lowacid foods packaged in hermetically sealed containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing. This final rule also establishes recordkeepingrequirements relating to temperatureindicating devices and reference devices maintained by the processor and allows for the use of advanced technology for measuring and recording temperatures during processing. Finally, this final rule includes metric equivalents of avoirdupois (U.S.) measurements where appropriate. This final rule will allow low-acid canned food processors to transition frommercury-in-glass thermometers to alternative temperature-indicating devices. Use of temperature-indicating devices that do not contain mercury will eliminate concerns about potential contamination of the food or the processing environment from broken mercury-inglass thermometers. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that it has submitted the informationcollection provisions of this final rule to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The notice also invites the public to submit comments on the information provisions to OMB. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB’s decision to approve, modify,or disapprove the information collection provisions of the final rule. DATES: This final rule is effective March 5, 2012. FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Center for Food Safety and Applied Nutrition (HFS– 615), Food and Drug Administration,
SUMMARY:

I. Background In the Federal Register of March 14, 2007 (72 FR 11990), FDA published a proposed rule entitled‘‘TemperatureIndicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers’’ (the proposed rule). We proposed to revise § 113.40 (21 CFR 113.40) to provide for use of temperature-indicating devices that accurately indicate the temperature during processing. We proposed that temperature-indicating devices shall be tested for accuracy against an accurate calibrated reference deviceupon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. We also proposed that the design of the temperature-indicating device shall ensure that the accuracy of the device is not affected by electromagnetic interference and environmental conditions. We proposed to require that each temperature-indicating device have a tag, seal,or other means of identity that will be used by the processor to identify the temperature-indicating device, and that each reference device have a tag, seal, or other means of identity that will be used by the processor to identify the reference device. We proposed the establishment and maintenance of written records to document the accuracy for each temperatureindicating device and each...