Insights in Public Health

Abstract

Reducing the occurrence of and influencing the rapid correction of food illness risk factors is a common goal for all governmental food regulatory programs nationwide. Foodborne illness in the United States is a major cause of personal distress, preventable illness, and death. To improve public health outcomes, additional workforce was required due to long standing staffing shortages and was obtained partially through consolidation of the Hawai‘i Department of Health's (HDOH) two food safety programs, the Sanitation Branch, and the Food & Drug Branch in July 2012, and through legislation that amended existing statutes governing the use of food establishment permit fees. Additionally, a more transparent food establishment grading system was developed after extensive work with industry partners based on three possible placards issued after routine inspections: green, yellow, and red. From late July 2014 to May 2015, there were 6,559 food establishments inspected statewide using the placard system with 79% receiving a green, 21% receiving a yellow, and no red placards issued. Sufficient workforce to allow timely inspections, continued governmental transparency, and use of new technologies are important to improve food safety for the public.

The Problem of Major Food Safety Violations in Hawai‘i's Food Industry

It is estimated that food illnesses in the United States cause approximately 3,000 deaths, 128,000 hospitalizations, and 48 million illnesses annually. The occurrence of approximately 1,000 reported disease outbreaks (local, regional, and national) each year highlights the challenges of preventing these maladies.¹

The HDOH investigated 247 foodborne illnesses in the State of Hawai‘i in 2014.² Symptoms of food illnesses can range from slight gastric discomfort to severe bouts of bloody diarrhea, vomiting, fevers, and organ failure that may result in hospitalizations, permanent disabilities, or even fatalities. Nearly all causes of foodborne illness are preventable if proper care is taken with food employee personal health and hygiene; maintenance of proper temperature controls regarding cooking, storing, cooling, and reheating of potentially hazardous foods; proper sanitizing and cleaning of food equipment and utensils; and ensuring that food is obtained from approved food sources. HDOH rules and regulations are designed to prevent or mitigate the causes and occurrences of foodborne illnesses by controlling these food illness risk factors.

The Food Safety Program is currently a consolidation of the Sanitation Branch and the Food and Drug Branch. The program belongs to the Environmental Health Services Division (EHSD) of the Hawai‘i Department of Health. The food safety program regulates the food industry through Hawai‘i Administrative Rules (HAR), Title 11, Chapter 50, Food Safety Code, and is authorized by section §321-11 of the Hawai‘i Revised Statutes (HRS).

Food establishments include: restaurants, caterers, lunch wagons, push carts, markets, liquor establishments, convenience stores, hotel banquet and room service kitchens, food manufacturers, institutional kitchens (schools, hospitals, prisons), day care centers, homeless feeding, temporary food sales events, food demos, fundraisers, etc, and are legally defined as;

1. Any place or portion thereof, maintained, used, or operated for the purpose of storing, preparing, serving, manufacturing, packaging, transporting, or other otherwise handling food at the retail or wholesale level;

2. Any place used for cleaning food equipment or utensils in support of another food establishment; or

3. Any operation that is conducted in or in conjunction with a mobile, stationary, temporary or permanent facility, or location where food is served, or provided to the public, with or without charge, regardless of whether the food is consumed on or off the premises.³

In 2009, the Sanitation Branch conducted 2,691 routine inspections of food establishments on O‘ahu.⁴ This represented only 46% of the 5,800 food establishments on O‘ahu at the time and resulted in an inspection frequency of over 2 years for each food facility. These routine inspections resulted in over 2,400 critical violations and over 2,800 non-critical or good manufacturing practices (GMP) violations.⁵ Only 20% of the 2,691 inspections had no violations, the other 80% had multiple violations. Critical violations are defined as foodborne illness risk factors that the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) has identified as the practices and behaviors that are the contributing factors to foodborne illness outbreaks within food service and retail food establishments.⁶ The risk factors are;

• Food from unsafe sources

• Poor personal hygiene

• Inadequate cooking

• Improper Holding/Time and Temperature

• Contaminated equipment/Protection from contamination

The 2,400 critical violations observed is extremely high and the multiple critical violation rate observed during routine inspections ranged from 40% to nearly 80% of all routine inspections in certain geographical areas.⁴ A multiple critical violation rate as low as 11% is achievable for world class food safety programs like Sacramento County, who in 2008, won the Crumbine Award for Excellence in Food Protection. Sacramento County was able to reduce the “yellow” placard rate to 11% during their routine inspections.⁷ The Crumbine Award is given annually to local environmental health jurisdictions that demonstrate unsurpassed achievement in providing outstanding food protection services to their community.

The critical violation rate observed during routine inspections was disconcerting, so it was imperative that the HDOH improve its food safety program. One of the main contributing factors to the high occurrence of food illness risk factors is the poor inspection frequency due to a lack of food inspectors. In 1999, the Sanitation Branch evaluated the inventory of food establishments statewide and categorized them into three risk categories that were based on the number of food operations present in the food establishment that impact public health. Eight operations (e.g. receiving, cold storage, hot storage, thermal processing, etc.) were identified to determine the complexity of the food establishment and the fees for the permit. Risk Category 3 ($50) food establishments, had 1–3 of the food operations. The Category 2 ($100) establishments had 4–5 and Category 1 ($150) establishments had 6–8 operations.⁸ The risk categories were also created to inspect the highest risk facilities more often than the lower risk facilities, but in FY 2010, O‘ahu had a ratio of 590 food establishments per inspector. This resulted in an inspection frequency of one inspection every 2 to 2½ years for each food establishment regardless of risk category as there were so few inspectors available. According to FDA recommendations, the ideal workload for food inspectors is 150 food establishments per inspector.⁹ This ideal staffing ratio would allow a food regulatory program that has 3 risk categories to inspect the Category 1 food establishments 3 times a year, the Category 2 establishments 2 times per year, and the Category 3 establishments once per year.

To achieve a ratio closer to the ideal 150 food establishments per year, the program would need to hire at least 20 more inspectors (from the existing 10 in 2010) to achieve a ratio of 200:1 as there were approximately 5,900 food facilities in FY 2010.

Resolving Staffing Shortages

It was very apparent that from 2002–2008, the competition between the Food Safety program and all other State departments for General Fund appropriations, coupled with the administrations political philosophy of not increasing the number of government employees would not produce any gains in the number of food safety inspectors.

The Food Safety Program then decided to take a bold step to change section §321-27 Environmental Health Education Fund (EHEF), of the Hawai‘i Revised Statutes (HRS) to allow the permitting fees to be used to “Conduct program activities and functions of the Sanitation Branch including permit issuance, inspections, and enforcement and the hiring of additional inspectors.”¹⁰ To that end HB36 was introduced in the 2009 legislature outside of the DOH's legislative package.¹¹ The bill easily passed the House and Senate chambers of the legislature, but was eventually vetoed by Governor Lingle.

In 2010, an identical bill to HB36 was introduced to the 2010 Legislature as HB2688 which again passed both chambers of the Legislature with no opposition and was signed into law by Governor Lingle.¹² HRS Section §321-27 was now the Sanitation and environmental health special fund. The annual ceiling on the fund was also increased from $300,000 to $1,500,000 to allow for the needed program support.

The task was still not complete as revenue from the existing permit fee structure was approximately $440,000 annually. This existing revenue would not be enough to allow the hiring of 20 new inspectors as well as transitioning from manually written inspection reports to a much needed electronic web-based inspection system. The program also wanted to introduce a new concept of a restaurant “grading” or placarding system that would be a major paradigm shift in the way the DOH regulated the food industry. The electronic web-based inspection system would allow immediate public access to food establishment inspection results. The placarding system would be a very high profile method of notifying the public the status of the most recent DOH inspection of the food facility by placing a highly visible, brightly colored 8 1/2″ x 11″ placard at the most visible location at the entrance to the food facility.

Once the authorization to allow the special fund to be used for all operational costs of the food safety program was approved by passage of Act 176/June2010 (HB2688), the program began drafting a new HAR to effectuate the change in statutes. By summer of 2012, the DOH had a draft of HAR 11–50, Food Safety Code. The length of time taken to revise the rules took nearly two years as it involved a complete rewrite of the existing food rules known as HAR 11–12, Food Establishment Sanitation which was approximately 82 pages in length. HAR 11–50 ended up as a 171 page administrative rule as the program adopted the 2009 FDA Model Food Code as the basis for the new HAR. In addition to being the vehicle to generate additional revenue and defining the “Stop-Light” food establishment placarding program, it was critical that the State's new food safety rules reflected a nationally recognized standard as well as the most current scientific thought on the control of foodborne illnesses and emerging pathogens.

In the Summer of 2012, between the final draft of the rule and public hearings that were held in October 2013, the food safety program met multiple times with the major stakeholders that would be affected by the new rule. Meetings and discussions with the Executive boards of the Hawai‘i Restaurant Association, the Hawai‘i Hotel and Lodging Association, The Hawai‘i Food Manufacturers Association and the Hawai‘i Food Industry Association produced very fruitful and frank discussions to justify the new HAR to the food industry prior to any official public hearings. The goal of the food safety program was to get industry “buy-in” for a doubling of the regulatory burden which expanded an 82 page rule to 171 pages, a quadrupling of the average food establishment permit fee from $46 to $200 by changing the existing fee schedule in HAR, and the introduction of a high profile food establishment placarding program that would notify the public of the most recent inspection results of the food facility. The new HAR Title 11, Chapter 50, Food Safety Code was signed by Governor Abercrombie in February 2014.

Implementation of Placarding — Chapter 50

The DOH recognized the fact that one of the biggest drivers of behavioral change in industry practices is governmental transparency. The placarding system was designed to greatly influence voluntary compliance with food safety regulations that protect public health. Prior to the implementation of Chapter 50, Food Safety Code, food establishments that were observed to have major violations typically needed multiple follow-up inspections and threats of permit suspensions or fines to completely resolve all critical violations. If the food establishment still did not come into compliance, the program would need to litigate the issue through lengthy, resource draining solutions by taking administrative actions that may include;

• Meetings with the offender to discuss why the food establishment is having difficulty complying with food safety regulations;

• Meetings with legal counsel (Deputy Attorney General) in obtaining a Docket No. and drafting and creating extensive legal documents that lead to creation of “Notice of Violations and Orders” (NOVO) that threaten permit suspensions and/or monetary penalties due to non-compliance;

• Scheduling and arranging formal Administrative Hearings with departmental hearings officers;

• Dealing with the outcomes of the hearings officers decisions which may not favor the DOH;

• Repeating the previous three bullet points in preparation for an appearance in Civil Court if the respondent contests the outcome of the Administrative Hearings.

The HDOH adopted a stop-light placarding system to alert the public to a food establishment's performance as the model for government transparency. Brightly colored Green (Pass), Yellow (Conditional Pass) or Red (Closed) placards are posted by the food safety field staff in a highly visible location at the entrance of the food establishment upon completion of a routine inspection (Figure 1). An establishment is issued a Green (Pass) placard if one critical violation or less is observed and corrected or mitigated on site prior to the completion of the inspection (Table 1). If two or more critical violations are observed, a Yellow (Conditional Pass) placard is issued. The yellow placard indicates which of the 5 critical violations mentioned on page 2, which lead directly to food illnesses, plus rodent/insect infestation, were responsible for the issuance of a Conditional Pass placard. Although rodent and insect infestations are not known as a direct cause of food illness in the United States, the general public and the HDOH have a universal aversion to the presence of rodents or insects in restaurants and other food establishments which may adulterate or contaminate the food supply. A Closed - Red placard is issued if there are imminent health hazards occurring such as no water, no power, sewage overflowing in food prep areas, or an active foodborne outbreak is ongoing as determined by our epidemiologists at the DOH Disease Investigation Branch.¹³

Figure 1.

Food Establishment “Stoplight” Placards, State of Hawai‘i

Table 1.

Summary of Placards Issued Based on Conditions Observed

	Placard Issued
Conditions Observed	Green “Pass”	Yellow “Conditional Pass”	Red “Closed”
	One critical violation or less. Violation must be corrected or mitigated prior to the conclusion of inspection.	Two or more violations. Requires a follow up inspection within 48 hours.	Imminent Health Hazard observed. (eg, active food illness outbreak ongoing, overflowing sewage, no power, no water.)

Other States food safety jurisdictions have used a traditional letter grading system, (A, B, C, Fail) or numerical system that indicates the inspection score out of 100 points. We strongly believe that the “stop-light” (Green-Yellow-Red) system is superior to either of these due to it being a zero-tolerance program for critical violations. ALL critical violations must be corrected if the food establishment is given a PASS-Green placard. It is difficult for the public to understand the difference between restaurants that received a “B” versus a “C” grade or what it means if a restaurant had a score of 83 versus 77.

The placarding system that Hawai‘i has adopted is concerned with critical violations that are “Foodborne Illness Risk Factors”, and not “Good Retail Practice” (GRP) violations such as unclean floors and walls which do not directly cause foodborne illnesses, but are still important factors in providing safe, wholesome and unadulterated food products.¹³ The food establishment inspection report in use at present is the national standard and is divided into two sections. The top section is labeled “Food-borne illness risk factors and public health interventions” represented by the first 27 items listed on the report. The bottom half of the inspection report is labeled as “good retail practices” and are represented by items 28–54 on the inspection report (Figure 2).

Figure 2.

Food Establishment Inspection Report, State of Hawai‘i

The placarding system is designed to avoid or greatly minimize the occurrence of possible litigation by encouraging voluntary compliance of food safety regulations through the use of societal pressure through governmental transparency of food safety inspection results. If a Yellow — Conditional Pass is posted at the food facility, it clearly notifies the public which, and how many of the 5 critical violations plus rodent/insect infestation were observed during the last inspection. Public notification that poor personal hygiene, or foods being subject to contamination, or any of the other 4 categories of food safety violations is shown to have a very strong negative effect on potential customers.

Achieving national uniformity among regulatory programs responsible for retail food protection in the United States has long been a subject of debate among the industry, regulators and consumers. Adoption of the 2009 FDA Model Food Code at the state level has been a keystone in the effort to promote greater uniformity. However, a set of widely recognized standards for regulatory programs that administer the Food Code was lacking. To meet this need FDA has developed the “Voluntary National Retail Food Regulatory Program Standards” (Program Standards) through ideas and input from federal, state, and local regulatory officials, industry, trade and professional associations, academia, and consumers on what constitutes a highly effective and responsive retail food regulatory program.¹⁴

Adopting national standards was a key component in obtaining “buy-in” from the regulated industry. The HDOH did not want to impose a local rule or philosophy that was divergent from a national standard. Hawai‘i is a very large player in the food industry with numerous corporate mainland restaurants, fast food outlets, and convenient store chains. Hawai‘i also is home to large national hotel chains like Sheraton, Hyatt, Four Seasons, Marriott, Disney, and others that, along with the restaurant chains, had already adopted either the 2005 or the 2009 FDA Model Food Code to use as their internal, corporate food safety quality control. The food industry was already ahead of the game prior to our introduction of HAR Chapter 50. The DOH needed to make sure that if it engaged in a high profile food establishment “grading“ program, that could have implications on the commerce of the food establishments, that it would need to be a nationally recognized set of criteria that the HDOH were judging the food establishments on to be defensible.

The food establishment placarding system was created to:¹⁵

• Reduce the incidence of major violations in the food establishment, thus reducing the risk of the public contracting foodborne illnesses or being exposed to harmful contamination of the food supply;

• Allow patrons to make informed decisions regarding food safety prior to entering the food facility;

• Increase compliance with food safety laws while reducing the number of follow-up inspections;

• Convey meaningful inspection results to the public and the food service industry using a system that is easy to understand; and

• Reward the food establishment for excellence in food safety.

The HDOH halted all routine inspections of food establishments in January 2014 and began the “How To Get A Green Placard“ (HTGAGP) campaign. The purpose of the campaign was for the food safety inspectional staff to visit ALL 10,000 plus food establishments statewide (5,900 on O‘ahu) with active permits to issue them a folder that contained everything they need to know regarding what our food safety staff would be concentrating on during routine inspections, and to explain the placarding program directly to food establishment owners and managers.¹⁶ The target date for completion on O‘ahu was June 30, 2014. The HDOH also arranged meetings with over 30 chain and individual groups of food service operators/owners in lieu of site visits for those companies that wanted all of their key managers and line personnel to get the same message at once. Our program took great care to ensure that the food industry would not be surprised with the application and enforcement of our new food rules, which were a true paradigm shift in the way the State DOH would regulate food establishments. The placarding violations and how to prevent them were also available in multi-language hand-outs. Chinese, Korean, Japanese, Ilocano and Tagalog, Thai, Vietnamese, and Spanish translated hand-outs were made available.

Present Results

On July 21, 2014 the DOH issued a Media Advisory in an effort to showcase the results of the first placards being issued under the new placarding program.¹⁷ Due to the media response, and the difficulty coordinating a surprise inspection for the media, the DOH had to settle for a last minute, arranged mock inspection at a local café that was closed for business. This had to be done to accommodate all three major news stations as well as the major newspaper. The Nielsen audience on the evening news that night was over 656,000 viewers through 24 news stories between 8:00 a.m. that morning on all the news shows until 10:00 pm that night.¹⁸ The media focused on the poor food establishments that were shown getting a Yellow Conditional Pass placard and which of the food illness risk factors (critical violations) were found at the facility. The next evening presented more of the same with an estimated Nielsen audience above 500,000 on follow-up stories. On August 22, 2014, a restaurant at a major shopping center removed the Yellow - Conditional Pass placard issued to them a day after the inspection. HDOH did another press release on this event on Sept 29, 2014, and another 470,000 Nielsen viewers saw the negative publicity surrounding the event.^19,20 The restaurant paid the HDOH a fine of $11,000 and indicated to the HDOH that they lost a significant amount of business immediately following the negative publicity.

As the one-year anniversary of the new placarding system and implementation of HAR, Chapter 50, Food Safety Code, approaches on July 23, 2015 some interesting, preliminary trends have unfolded (Table 2). In the first three months, from July 23 until October 31, 2014, 32% of all food establishments that underwent routine inspections, were issued Yellow Conditional Pass placards. This means that one out of three restaurants were operating with multiple foodborne illness risk factors present. The months of November and December saw significant decreases to 19% and 16% Yellow placards issued, then became very stable over the last five months, from January until May showing the following results 23%, 26%, 25%, 24%, and 23% of yellow placards issued respectively. The very preliminary results have shown a steady reduction from one in three facilities being issued yellow placards under the new HAR Chapter 50 inspections, to one in four facilities at present. These statistics are very promising for the new food safety rules in showing a significant drop in the occurrence of foodborne illness risk factors in the regulated community.

Table 2.

Hawai‘i Placard Issuance Results by County, Aug 2014–May 2015

Date	Honolulu County				Hawai‘i County				Maui County				Kaua‘i County
	G	Y	R	%Y	G	Y	R	%Y	G	Y	R	%Y	G	Y	R	%Y
2014
AUG*	336	143	0	30
SEP	298	161	0	35
OCT	283	130	0	31
NOV	240	58	0	19
DEC	421	80	0	16	335	51	0	13	494	66	0	12	95	36	0	27
2015
JAN	257	76	0	23
FEB	322	112	0	26
MAR	387	130	0	25	466	65	0	12	391	19	0	5	115	40	0	26
APR	379	120	0	24
MAY	349	104	0	23
TOTAL	3,272	1,114		25	801	116		13	885	85		9	210	76		27

^*Note: August time period for 2014 started on July 23, 2014

Future Goals

The signing of Act 176/June 2010 was responsible for a staffing increase from 9 field staff in 2011 to 29 at present with only 2 more vacant positions that are actively being filled for a total of 31 field inspection staff. The full staffing levels that we have achieved will allow the HDOH to consistently inspect Hawai‘i's food establishments at an optimum frequency of at least 1 to 3 times per year based on their risk factors. Only eleven of the twenty-nine field staff at present have greater than 4 years of food safety experience, so it will be another three years before the majority of the field staff will be at a level of being fully independent, capable of immediate field interpretations of all food safety regulations, and having reached a level of efficiency and competency to inspect all food establishments at the appropriate frequency. The food safety program fully expects to see the number of Yellow placards issued decline to further lows.

The next greatest influence to further reduce the occurrence of food illness risk factors will be the launching of our new web-based food safety inspection system. The HDOH recently awarded a contract to create and maintain a fully electronic web-based food safety inspection system. The main highlight of the system that the HDOH hopes to reduce food illness risk factors further, will be complete public access to all of our food establishment inspection results. The philosophy of transparent government being used to drastically change industry behavior for the better will literally be on display for the whole world to see. The new information technology vendor will introduce a public portal with easy drill down menus to access HDOH food establishment inspection reports online. The Green/Yellow/Red Placards may also be imbedded with a Quick Response (QR) code so any potential customer can wave their smart device/phone over the placard and immediately see the results of the last inspection.

Technology combined with governmental transparency can be a powerful tool in influencing positive industry behavior to drastically reduce food illnesses or the adulteration of foods by eliminating the occurrence of food illness risk factors. The food industry in Hawai‘i will never be the same (thankfully) due to the adoption of new food safety rules, new technologies and immediate public access to food establishment inspection results.