Annex 3 Public Health Reasons/ Administrative Guidelines
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Public Health Reasons/Administrative Guidelines This document is constructed as an educational aid to apply the ―2005 FDA Model Food Code Public Health Reasons‖ to sections 110 through 451 of the IC 410 IAC 7-24 Retail Food Establishment Sanitation Requirements Rule. Not every section has an individual public health reason. The document is formatted to match the structure of the Indiana Retail Food Establishment Sanitation Requirements, hereafter referred to as the ―Rule‖. It may be helpful at times to refer to similar sections of the 2005 FDA Model Food Code. This Public Health Reasons/Administrative Guidelines (PHR) document can be used to support decisions, improve the knowledge level of staff, and to educate or advise retail establishments on best practices. Throughout this document are web references that are recommended for use to support recommendations. Key to Abbreviations ANSI- American National Standards Institute PIC- Person-in-Charge CFH -Certified Food Handler RA- Regulatory Authority CFP- Conference for Food Protection RFE- Retail Food Establishment HSP- Highly Susceptible Population ROP-Reduced Oxygen Packaged PHF- Potentially Hazardous Food RTE- Ready-to-Eat MANAGEMENT & SUPERVISION 410 IAC 7-24-110 Requirement for facility and operating plans 410 IAC 7-24-111 Contents and specifications for facility and operating plans In conjunction with the CFP Plan Review committee, FDA has participated in developing a document that is intended to assist regulators in reviewing retail food establishment plans, and industry in understanding what is expected in the plan review process. For several years, this FDA/CFP Food Establishment Plan Review Guide – 2000 has been used in the FDA State Training Team Plan Review courses. It can be accessed through http://www.cfsan.fda.gov/~dms/prev- toc.html. The Plan Review Questionnaire developed by the Department is recommended for use when evaluating plans (http://www.in.gov/isdh/20640.htm). At the plan review stage, the regulatory authority may be dealing with an agent of the permit applicant who is seeking a building permit and who is not in a position to discuss plans for safely conducting the food operation. Nonetheless, the plan review step presents a unique opportunity to lay a foundation that enables the proposed operation to proactively sustain compliance with the Rule over time. Standard operating procedures (SOPs) are a part of that foundation and ideally are developed in tandem with designing the facility. Consequently, as an integral part of the plan review process, discussion needs to occur about such procedures and their scope. SOPs need to be developed by the time of the preoperational inspection and put into effect when the food operation begins. It is recommended that such procedures be written, available for reference by the PIC, conveyed to the appropriate employees, and available for review by the regulatory authority during inspections. Operating procedures should include definitive practices and expectations that ensure that: (1) The transmission of foodborne disease is prevented by managing job applicants and food employees as specified under sections 120-127. (2) Food is received from approved sources as specified under section 142 (3) Food is managed so that the safety and integrity of the food from the time of delivery to the establishment throughout its storage, preparation, and transportation to the point of sale or service to the consumer is protected, (4) The time or temperature control of PHF is maintained, including freezing, cold holding, cooking, hot holding, cooling, reheating, and serving in conformance with the temperature and time requirements specified under sections 152, 162, 163, 182, 183, 185-199. (5) Warewashing is effective, including assurance that the chemical solutions and exposure times necessary for cleaning and sanitizing utensils and food-contact surfaces of equipment are provided as specified under sections 248, 276, 287, 295, 296, and 298-303, and 2 (6) Records that are specified under sections 159, 160, and 356, are retained for inspection. During the plan review stage, the regulatory authority and a management representative of the proposed retail food establishment should discuss available training options that may be used to train food employees and the PIC regarding food safety as it relates to their assigned duties. By the time of the preoperational inspection, operating procedures for training should include definitive practices and expectations of how the management of the proposed retail food establishment plans to comply with & section 119 (l2) of the Rule which requires the PIC to assure that food employees are properly trained in food safety as it relates to their assigned duties. 410 IAC 7-24-112 Food equipment; certification and classification Under ANSI document CA-1 ANSI Policy and Criteria for Accreditation of Certification Programs, it has been stipulated that: "For food equipment programs, standards that establish sanitation requirements shall be specified government standards or standards that have been ratified by a public health approval step. ANSI shall verify that this requirement has been met by communicating with appropriate standards developing organizations and governmental public health bodies." The term ―certified‖ is used when an item of food equipment has been evaluated against an organization's own standard. The term ―classified‖ is used when one organization evaluates an item of food equipment against a standard developed by another organization. 410 IAC 7-24-114 Variance The ISDH variance policy describes the process for submitting a request for a variance and for approving, denying, and revoking a variance of certain Indiana State Department of Health food safety rules. The policy applies to each request for a variance submitted by a person on behalf of a retail food establishment(s) or proposed retail food establishment(s) operated or intending to operate in the State of Indiana, except that variances shall not be considered for temporary retail food establishments. It also applies to persons to whom a variance has been granted or revoked. ISDH Food Protection Program Variance Policy Purpose This policy describes the process for submitting a request for a variance and for approving, denying and revoking a variance of certain Indiana State Department of Health rules. Scope This policy applies to each request for a variance submitted by a person on behalf of a food establishment(s) or proposed food establishment(s) operated or intending to operate in the State of Indiana, except that variances shall not be considered for temporary food establishments. It also applies to persons to whom a variance has been granted or revoked. Law IC 16-19-3-4.3 Sec 4.3. Upon a showing of good cause, the executive board may grant a variance from one (1) or more of the state rules concerning; (1) food handling machinery; or (2) sanitary standards for the operation of food establishments. IC 16-42-5-5.2 Sec. 5.2. The state department may grant a variance from one (1) or more of the state rules concerning: (1) food handling machinery; or (2) sanitary standards for the operation of food establishments in accordance with IC 16-19-3-4.3. 3 Section 114–Process for Variances Written notice of request given to Assistant Request for -affected: Commissioner variance -Regulatory authorities (RA)s Immediately (AC) convenes within 15 business days - LHDs received variance review -other interested parties committee (VRC) 30 business days AC grants or denies VRC receives comments from variance based on VRC recommends to AC -affected: showing of good variance should be -RA(s) cause granted or denied 30 business -LHDs days -others if denied then deliberates if granted Appeals process Appeal is unsuccessful; Notice of grant given to: variance denied -requestor -RA(s) . -LHDs Appeal successful & -Affected parties variance granted Copy retained at Course of instruction and/or establishment guidance documents provided by agency and/or requestor to Use of variance at listed affected RA(s) and LHDs establishments Section 114– Variance Revocation Process. (Indiana Policy as of June 2006) Inspections AC revokes Grantee may Appeal show variance w/ file an appeal Follows repeated notice to: of the IC 4-21.5 failure to -grantee revocation of comply with -affected RA the the terms of -LHDs variance the variance 4 410 IAC 7-24-117 Assignment of supervision responsibility Designation of a PIC during all hours of operations ensures the continuous presence of someone who is responsible for monitoring and managing all retail food establishment operations and who is authorized to take actions to ensure that the Rule's objectives are fulfilled. During the day-to-day operation of a retail food establishment, a person who is immediately available and knowledgeable in both operational and Rule requirements is needed to respond to questions and concerns and to resolve problems. 410 IAC 7-24-118 Demonstration of Knowledge The restaurant industry accounts for 5% of the gross domestic product, employing 12.8 million people. The 935,000 U.S. restaurants generate $537 billion in sales and provide 70 billion meals and snacks annually (2007), with an average of $1,054 annual per capita spending on the five meals or snacks per week. According to the Healthy People 2010, ―Objective 10: Food Safety‖, one of the major issues that affect foodborne illness, is ―training of retail employees‖. The use of safe practices spelled out in the U.S Public Health Service‘s FDA Food Code should reduce outbreaks. Considering the number of meals consumed in restaurants, food safety must be a very important activity for all food employees and owners. CDC monitoring data estimates that 76 million illnesses, 325,000 hospitalizations, and 5000 deaths each year may be associated the microorganisms in food. The FDA reported that 59% of reported illness outbreaks were associated with restaurants in 2005. FDA research has identified three main factors that result in foodborne illness: poor personal hygiene, cross contamination, and time/temperature control.