Pursley gave an overview on audits before detailing events that helped result in setting the standards companies are audited against. Pursley noted it’s important to have the right people involved in an audit. “There are lots of people who should know the processes but they spend a lot of time in the office and what they know is what other people tell them is going on. I have been out there before where you find something and they’re in shock. Well, what’s my impression if you’re the person in charge and you’re in shock? So make sure you’ve got the right person there. And sometimes you may think it should be you but if you don’t have the time to be intimately familiar with the operation, it probably should be someone else. So don’t make that mistake,” he advised.

“Where has food safety been?” he asked. “It’s gone through a whole gamut of things over time. If you go back to 1906 to Upton Sinclair’s book ‘The Jungle’ - what the book was about was certainly not food safety or hygiene. But because of the book and the impact it had, we got our first federal regulation. What I want you to understand about this is that it is an event – something that happened which affected our consumer. It affected confidence. It affected trust. And, as a result, you got federal regulations because it became a political event – not because it was a scientific event.”

“The Food & Drug Act is one of the best written documents in the world and I’ll tell you why,” Pursley said. “It came out in 1938. In 1948 they began to get their act together and federal inspectors came in to food processing plants and found they were filthy. But instead of coming in and telling us what to do, they came in and said, ‘If you don’t get your act together, I’m going to throw you in jail.’ And the food industry responded by asking what the standards are and asking for help. The regulators replied, ‘We’re not here to help.’ It was a very divisive time and set the stage for regulations and the relationship with regulators and the food industry.”

There are a number of ways to comply – through education, through inspection and audit programs, said Pursley, adding it’s important to understand what this regulation means and what the world class standard is or what one’s customers’ expectations are. He said hygiene and sanitation (before GMP) were characterized by one statement – “A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substances, or if it is otherwise unfit for food.” He compared that to past regulations. “The first food regulation I ever read and enjoyed was back in the Ming Dynasty which said, ‘If meat causes illness or death, that meat must be destroyed by fire.’ Now that’s clear cut – no one should confuse it.” Posing a hypothetical question to the audience Pursley asked: “Now what were the analytical tools at that time? Well, I guess you could smell it, but that doesn’t tell you a whole lot. So basically you ate it and if it killed you or made you sick, you destroyed it. But I also liked the penalty phase of the Ming Dynasty: if you knowingly sold meat that caused illness or death, you would be destroyed by fire! That seems easy enough to understand. There were no court systems. It’s like doing crime in Texas – you’re going to die! If your product was contaminated, you had violated the law. That worked!”

He then moved in time to the 1960s. “A lot of things happened. Our president was assassinated; his brother was assassinated; the leader of our civil rights movement was assassinated. I was brought up in that generation,” said Pursley, calling it a generation of new words and new terms. Rachel Carson wrote her book Silent Spring which created a chemo-phobia – a fear of chemistry. And new words came up like carcinogen. “I didn’t even know what carcinogen was as I was a very young man. But my grandmother got cancer and in those days you brought your loved ones in the house. I was there with her every day while I watched this robust woman dwindle down to nothing. And I read in the newspaper that cranberries cause cancer – they’re carcinogenic. It was a cranberry scare. I, of course, learned since then that cranberries had nothing to do with her cancer but to this day, I won’t eat a cranberry. It’s not because I’m afraid they’re going to kill me, but when I’m around cranberries or hear the word cranberry I think of my grandmother weighing 70 lbs and dying.” Pursley also mentioned the other times where he thinks about her fried chicken and that secret ingredient that makes fried chicken better than anyone else’s – lard. “That’s what they cooked it in then and it was great,” said Pursey.

And then Ralph Nader wrote a book, “Unsafe at Any Speed” about a car – a Corv air – and how this Corvair was involved in more injury and fatality accidents than others. “He used government statistics, wrote this book and proved to us this car is unsafe. And the government’s responsibility to this was what? They couldn’t do a thing because General Motors was the largest manufacturer in the world,” said Pursley. “But Betty Furness came out on TV in New York City and consumer activists came out against the Corvair and the Pinto and these cars are history! And they’re history not because government eliminated them; they’re history because of consumer activists. Consumers started demanding and questioning things.”

He then moved to red dye #2. “Why did we use it - for safety? No, we used it solely to market product – it made hot dogs look fresh. It gave them that red color. We made strawberry soda and all of a sudden it tasted like strawberries. The soda always tasted like strawberries and smelled like strawberries but until you put the red in it, nobody recognized it. We put preservatives in bread to extend shelf life. We did all these things without involving the customers and we got a black eye. When we get a black eye, FDA gets a black eye. Consumer activism took over. government and the food industry had to respond.

The 1970s introduced Section 401(a)(4): A food shall be deemed adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated or whereby it may have been rendered injurious to health.

“We had to create a standard – a guideline – and consequently the word ‘GMP’ came into play,” said Pursley. “What upsets me is when I talk to people about the GMPs is they talk about hairnets. GMPs are not about hairnets. The GMPs do take people into consideration. They talk about plant design. They talk about preventative programs, cleaning schedules, preventative maintenance schedules and quality assurance.” They include the transportation system, the distribution system and the warehouse, he added, saying they are very inclusive documents. “There is a pretty darn good list of items that need to be in place,” Pursley said. He said a court case in the 1970s further improved food safety because the court ruled it didn’t matter whether company presidents knowingly participated in unsafe practices; he/she was responsible. In the case, one of the company’s warehouses was in Philadelphia and one was in Baltimore and the FDA treated it as one facility. Pursley referred to this as the beginning of corporate quality issues, corporate sanitation, etc.

Pursley said the 70s and 80s were a time of tremendous progress in food safety. “The kicker,” he said, “came in the 1980s when food safety became good business. It wasn’t a regulatory thing anymore.” He said as a result of politics, FDA recognized it wasn’t going to get any more money and wouldn’t be able to inspect 63,000 food processors; it didn’t have the manpower, the time or the resources. “They basically went into that 20 percent of the food industry which produces 80 percent of the food (Kraft, General Mills, etc.) and looked at their programs – top to bottom. And they did good quality audits, good hygiene audits. What they found in many of these companies were very good programs.” He said when they asked these companies about their supply chains, they were told their suppliers have specifications, they check against these specifications and they check the trucks when they come in. “The government advised if there’s something wrong, they should cite them. But they were not going to that factory and making sure that they were in compliance with food safety. So that was when the big push for third-party audits started.” He said that necessitated changes. “Up until that time AIB inspected against a standard. Then we had to not only consolidate our own standards but others’ standards. They had to expand their quality umbrella to the supplier so they had to develop partnerships and select supplier programs. And all of a sudden food safety is more market driven. It becomes part of your market plan rather than a regulatory plan.”

Then, he said, came the 90s and HACCP, QSE and ISO in the 90s. “Our experience in the United States on ISO hasn’t been very positive,” said Pursley. “The problem with ISO is it didn’t include the first two important elements of securing the supply chain: 1) Are the GMPs and prerequisites in place? 2) Is HACCP is place?” Europeans are very ISO-driven and they don’t always see what makes sense. “I’ve visited Europe several times in the 90s to do inspections and they’d get upset with me because they failed an AIB audit,” said Pursley. “They thought because they were ISO certified, everything was compliant. I’d have to tell them I was aware of that and it’s something they should be proud of but there was a need to review this report to see what is wrong. The GMPs and prerequisites and food safety are the first elements of a quality system and they’re non-negotiable,” Pursley said.

“Another event that has changed everything is September 11,” said Pursley. “The best security tool you have is not the camera or the fence – it’s your employees. If you can train your employees to be aware and cognizant of these concerns all the time, you’ve got the best security program that you can put together. It’s not whether the program is good or not – it’s how it’s implemented.”

“Now the Global Food Safety Initiative – this group of people – is trying to get a common standard,” Pursley said. “And it’s very difficult to get everyone thinking along the same line because it’s not what’s easy and it’s not what could be popular – it’s what is going to put confidence in the marketplace that a system is working.”

Confidence is going to be built by understanding the three basic elements of food safety, Pursley said. An integrated quality system (IQS) is a system that addresses food industry concerns, namely prerequisite programs, food safety and quality in an integrated manner, he added. “You must have confidence in the environment in which you’re manufacturing – it’s the people, the factory, the equipment – all of those things. You cannot have a HACCP plan without the prerequisites because HACCP assumes the prerequisites are in place.” Pursley emphasized the need to know the food was produced in a safe environment and that critical control points needed to ensure its safety are in place. “That’s confidence. These are not negotiable items. Once we have those in place, we have confidence now that we can establish our quality programs into our system and we can ensure that we meet our customers’ specifications. Those assumptions – prerequisites, food safety – cannot be made without ensuring they are in place through some type of validation or verification system.”