Regulatory View of

Microwave PasteurizationGregory J. Fleischman, Ph.D.

Institute for Food Safety and HealthU.S. Food and Drug Administrationgregory.fleischman@fda.hhs.gov

June 10, 201145th International Microwave Power Institute Symposium

FDA and USDAFDA regulates…

foods except meat and poultry productsfood products containing less than 2 percent cooked meat/poultry and containing less than 3 percent raw meat.the manufacturing of meat sauces and most soupsgame meat (e.g., venison, ostrich and snake)eggs after inspection

USDA regulatesmost meat and poultryeggs at the production level

Pasteurization

Interpretation:

“Any process, treatment, or combination thereof, that is applied to food to reduce the most resistant microorganism(s) of public health significance to a level that is not likely to present a public health risk under normal conditions of distribution and storage.”

National Advisory Committee on Microbiological Criteria for Foods. 2006. Journal of Food Protection, Vol. 69, No. 5, 2006, Pages 1190–1216

Defined in Section 403 of the Federal Food, Drug, and Cosmetic (FD&C) Act [21 U.S.C. 343] as amended by the 2002 Farm Bill

ExamplesMilk

governed by the Pasteurized Milk Ordinance (PMO)the PMO is prescriptive, stipulates time/temperature requirementstarget organism: originally Mycobacterium tuberculosis, now Coxiella burnetii

Juicegoverned by the Juice HACCP Regulation (21 CFR 120.24(a))each juice requires its own HACCP plantarget organism: variable, and may be other contaminants as well, e.g., chemical contaminants

Eggsgoverned by the 2009 Egg Safety Action Plan (21 CFR Parts 16 and 118)Producers are exempt from 6 of 7 provisions of this plan by pasteurizing eggsTarget organism: Salmonella Enteritidis

MicrowavePasteurization

21 CFR 179.30

Radio frequency radiation, including microwave frequencies, may be safely used for heating food under the following conditions:

The radiation source consists of electronic equipment producing radio waves with specific frequencies for this purpose authorized by the Federal Communications Commission.The radiation is used or intended for use in the production of heat in food wherever heat is necessary and effective in the treatment or processing of food.

Achieving PasteurizationTalk to FDA concerning process goal

Identify target organism(s)

Determine level of inactivation required• determine initial potential bacterial load• establish variations in this load

Determine the effect of the food matrix on organism survivability

Insure that process does not create a hazard as a consequence to pasteurization

Validate the process

Verify the process

Submit findings to FDA

Achieving PasteurizationTalk to FDA concerning process goal

Identify target organism(s)

Determine level of inactivation required• determine initial potential bacterial load• establish variations in this load

Determine the effect of the food matrix on organism survivability

Insure that process does not create a hazard as a consequence to pasteurization

Validate the process

Verify the process

Submit findings to FDA

Validation and Verificationof Pasteurization Processes

Validation = does your process work?demonstrate that pasteurization is achieved throughout foodestablish critical factors and their acceptable rangeestablish means to monitor critical factorsinsure that validation procedure doesn’t change process

Verification = does it keep working?monitor critical factors

Potential Critical Factorsin Microwave Pasteurization

Food factors• composition• physical characteristics (shape, size, volume)• physical state (liquid, solid, ice)• changing product parameters (e.g., specific heat)

Process factors• power level and cycling• process time• equilibration time

Equipment factors -- magnetron frequency and age

Packaging -- effect on process delivery

The Microwave Validation Challenge

Discrete processing (individual packages) is not straightforwardnon-uniform temperaturesonly indirect assessment of temperature levels possibleexample: microwave pasteurization of shell eggs

Continuous processing (liquids) is straightforwardadequate mixing assures uniform temperaturesdownstream direct measurement of temperature levels

Shell Egg Pasteurization

Clear vs. Cloudy albumen

Uniformly inoculated egg

FDA Review

FDA doesn’t…• prescribe validation protocol• approve processes

FDA does…advise producers on what is expected in a validation protocolreview validation protocolIssues a letter of no objection if validation protocol is deemed sufficient to support pasteurization claim