Adopted
REGULATORY ANALYSIS
for
Amendments to Colorado Retail Food Establishment Rules and Regulations
Adopted by the State Board of Health
November 21, 2012
1. A description of the classes of persons who will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule.
Retail food establishments include restaurants, grocery stores, mobile food carts, food vendors at temporary events and farmers markets, and food service operations in schools, correctional facilities and other non-exempt institutions. Wholesale food processors and manufactures will not be affected. The cost to implement the revisions to these regulations is minimal. The cost to implement the provision for consumer advisory is a new provision and may have more effect on operations that are not part of a restaurant chain. Compliance with this provision does not require menus to be reprinted. Compliance can be as simple as providing simple brochures, label statements, table tents, placards or other effective written means. Consumer advisory implementation and guidance from FDA has been in place now for more than a decade and most restaurant chains already have consumer advisory provisions in place due to the predominance of other states that have adopted this requirement. To allow ample time to comply, we are proposing that the consumer advisory provision not be effective until July 1, 2013. Local public health agencies will enforce the regulations in 54 counties with local control; whereas the division currently enforces the regulations in the remaining 10 counties without local control. The public will benefit from the revisions, which are scientifically based to prevent the occurrence of foodborne illness. While the adoption of the FDA Model Food Code (Food Code) is not mandated, it is strongly favored by industry, particularly by national chain restaurants and grocery stores. This will allow Colorado to meet the Voluntary National Retail Food Regulatory Program Standards, a measure of an effective retail food program.
2. To the extent practicable, a description of the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons.
The vast majority of the revisions provide clarity and alignment with the U.S. Public Health Service – Food and Drug Administration’s (FDA) 2009 Model Food Code. This will ensure uniformity, therefore enabling industry to not only be required to meet food safety standards which are recognized nationally but also operate under one set of uniform regulations that will not vary from county to county. This regulation does not apply to establishments in the City and County of Denver, whose regulatory requirements are governed by local ordinance and are exempt by statute from using the proposed regulations. The City and County of Denver was involved in the stakeholder process, and is a current and historical partner with the department and other local health jurisdictions in assuring their requirements are substantially equivalent to these regulations.
New requirements designed to control the growth of Listeria monocytogenes (LM) and Clostridium botulinum (C. bot) in food processed using reduced oxygen packaging have been added, along with date marking requirements for potentially hazardous foods prepared on site. However, these requirements apply only to facilities serving highly susceptible populations (HSP), such as health care, assisted living, kidney dialysis centers, hospitals and nursing homes, the most vulnerable populations to LM.
The proposed regulations also include a new requirement for establishments serving raw and undercooked animal products to notify consumers of the significantly increased risk of consuming such foods, referred to in the Food Code as “consumer advisory”. The purpose of consumer advisory is to ensure consumers are aware that consuming raw and undercooked animal products poses an increased risk of illness from bacteria such as E. coli and Salmonella. This requirement has been recommended in previous versions of the Food Code and has been adopted by a number of states.
The portion of the regulations addressing the presence of animals in retail food establishments, and the definition of service animal have been revised and clarified to align with the Americans’ with Disabilities Act (“ADA”) and the Food Code. These proposed changes will ensure Colorado regulators are applying appropriate allowances for service animals while protecting against the risk of foodborne illness associated with the presence of animals in retail food establishments.
Each new requirement is aligned with nationally recognized standards and practices and provides better public health protection within the retail food industry in Colorado.
3. The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues.
CDPHE currently provides technical assistance, interpretations, training, and educational materials to local public health agencies (LPHA) and the regulated community. Since these services are on-going and a function of the program, as it currently exists, little impact is anticipated for the addition of these services with the proposed regulations. The Division has been anticipating adoption of these revisions and has been disseminating information and providing technical assistance to LPHAs regarding the regulatory changes to assure a smooth transition. Additionally, an on-line training focused on the revisions has been developed that will be accessible by LPHAs and industry.
4. A comparison of the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction.
The proposed rule change is in response to a change in the Food Code, which is updated every two years. Colorado’s regulations have not been comprehensively revised since 2004. This revision will keep Colorado uniform with the rest of the country and on pace with national science-based recommendations.
More closely aligning Colorado’s regulation to with nationally-recognized standards will provide better public health protections and uniformity for industry. Alignment will allow Colorado to meet the goals set forth in the Safe Food Winnable Battle and the Voluntary National Retail Food Regulatory Program Standards, which is a measure of an effective retail food program.
Antiquated restrictions on regulatory agencies have also been lifted. For example, the section requiring that the inspection form be delivered by the end of the next business day after the inspection has been removed. This will allow the flexibility needed for agencies using lap tops and handheld devices in the field to electronically deliver inspection reports even when a wireless connection is not readily available. In addition, the requirement for a set inspection interval of twice a year for all facility types was revised to allow for the application of risk-based inspection frequencies, a nationally recognized standard.
The probable costs and benefits of inaction are not easily quantifiable. Today, health experts estimate that annually, one in six Americans (or 48 million people) get sick from, and 3,000 people die from, foodborne diseases. Reducing foodborne illness by just 10 percent would prevent 5 million Americans from getting sick each year. Preventing a single fatal case of E. coli O157 infection would save an estimated $7 million dollars. Additionally, failure to more closely align with federal standards will leave Colorado citizens with fewer public health protections, regarded as minimal standards, than in many other states. The Department and our local partners will be less likely to meet the Voluntary National Retail Food Regulatory Program Standards and therefore less able to compete for federal funds which are availed to food safety programs aligned with national standards. Industry will continue to struggle with requirements that are not aligned with federal standards and the rest of the nation, and will have only minimal standards to protect their establishments from being implicated in a foodborne illness outbreak, a devastating blow to any business.
5. A determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.
Every effort was made when developing the proposed regulations to take into consideration the probable impacts. It was developed in accordance with the Food Code in order to be consistent with retail food establishment codes throughout the nation. The Colorado Restaurant Association, the FDA, State, local public health agency personnel contributed in the development of the revised regulations to assure that the requirements would not be excessive. Since the proposed regulation does not impose any new direct costs on the industry, local public health agencies or this Department, the Department feels that the proposed rule, as submitted, is the least costly and the least intrusive method for achieving its purpose of assuring a safe food supply
6. A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule.
Updating the existing rules and regulations with the most current information based on scientific and technological advancements is in the best interest of the industry, the regulating agencies and the consuming public. We considered adopting the Food Code in its entirety. However, throughout this lengthy stakeholder process, regulators and industry consistently requested that we thoroughly and carefully consider each provision and decide what was best for Colorado. This group of stakeholders spent over three years revising this regulation to more closely align with federal recommendations. We believe that the requirements proposed in this revision are the best possible alternative to the wholesale adoption of the Food Code, represent the interests of the stakeholders, maintain Colorado’s regulatory framework in alignment with national standards, and is protective of public health.
7. To the extent practicable, a quantification of the data used in the analysis; the analysis must take into account both short-term and long-term consequences.
DEHS does not take the impact of new regulatory requirements lightly. This lengthy stakeholder process involved many representatives from both industry and regulatory agencies. Each new requirement was painstakingly examined to determine whether any associated cost, direct or indirect, was commensurate with the public health benefit it provided. To illustrate this point, the approach taken to address the issues of the Listeria monocytogenes (LM) and the requirement for date marking is detailed below.
Listeria monocytogenes (LM) is a serious and life threatening illness to anyone that is very young, or old or immune compromised, yet it poses little risk to most healthy young people and adults. Minimizing exposure to foods that are more prone to the growth and proliferation of LM in these vulnerable populations will have a significant public health impact, while keeping the burden on industry and regulators low. For this reason, the new requirements for date marking of foods and for pre-approved HACCP plans for foods processed using reduced oxygen packaging will only apply to establishments serving high susceptible populations, such as health care, assisted living, kidney dialysis centers, hospitals and nursing homes.
While in the Food Code these requirements apply to all retail food establishments, there is little evidence beyond theoretical risk, that LM or C. bot have caused foodborne illness in foods that have been processed using reduced oxygen packaging methods.
Requiring date marking in only these setting will protect the most vulnerable populations and minimize the burden on industry and LPHA’s enforcing these new requirements.
Careful consideration was taken regarding every new requirement in this proposed regulation. In some instances, changes were made to lessen the burden on industry and regulators and in many other cases changes were made merely to clarify ambiguous language. This proposed regulation is the result of extensive work, the input of many and is the best set of minimal requirements to protect Coloradoans from foodborne illness.