Regulatory changes related to passage of the Food Safety Modernization Act, which will cover shell egg packing operations, have begun to be announced. The proposed rule, Preventative Controls for Human Food, is in a comment period now and is an example of the new regulatory requirements that egg packers will be facing. The proposed rule would require egg packers that don’t have a farm exemption to have a HACCP-like food safety program.
Christina Kelley-Astorga, consultant, Food Safety and Quality Systems, said that egg packers don’t have to have a HACCP plan now, but ultimately all processors of food intended for human consumption will be required by the Food Safety Modernization Act to have a verified and validated HACCP plan. “They [U.S. Food and Drug Administration] just haven’t figured how to roll it out yet,” she said.
“The Food Safety Modernization Act is essentially for the FDA what the Mega-Reg was for the USDA in the 1990s for inspection of meat and poultry,” Kelley-Astorga said. The Mega-Reg ultimately led to the implementation of HACCP plans in red meat and poultry slaughter plants and a number of other changes by the USDA Food Safety and Inspection Service. She explained that while regulations have not required egg packers to have HACCP plans, many egg packers have implemented HACCP on their own.
“Fresh shell eggs were one of the top five items identified by retailers as requiring GFSI [Global Food Safety Initiative] certification to meet food safety minimum guidelines,” Kelley-Astorga said. Over 180 U.S. retailers now require their suppliers to be GFSI certified. Since many egg producers pack predominantly private label eggs, the movement of U.S. retailers to GFSI, which started about five years ago, has driven many egg producers into GFSI-recognized food safety programs like SQF. “You can’t pass GFSI without having a verified and validated HACCP system,” she said.
CCPs for egg packing
A critical control point is a step or procedure where a physical, chemical or microbiological hazard that can cause injury or illness can be prevented, eliminated or reduced to acceptable levels. “There has been a debate as to whether or not critical control points even exist for packaging fresh shell eggs,” Kelley-Astorga said. “In the egg industry right now, some companies will have critical control points and some people won’t. There is nothing that mandates a critical control point.”
“Some people argue that Salmonella enteritidis can be inside the egg, not just on the shell, so washing the shell is not a critical control point because it doesn’t do anything about Salmonella enteritidis inside the egg. Others would say that the most likely source of Salmonella enteritidis contamination is from fecal matter on the shell of the egg so washing the egg properly is a critical control point,” she said.
“Whether or not the egg packer chooses to call the egg washer a critical control point or just a control point, they monitor the temperature and pH of the wash water the same way. It is just a preference in how they choose to define it in their HACCP plan.”
For shell eggs, just as for raw meat and poultry products, the final control measure for food safety is cooking. Since the original implementation of HACCP in slaughter plants when they were required to have at least one critical control point identified, the Food Safety and Inspection Service has changed its position and now doesn’t require a critical control point. Kelley-Astorga said that there are slaughter plants that have passed Food Safety Assessments by the Food Safety and Inspection Service without critical control points in their HACCP plans.
Kelley-Astorga said that, in her opinion, refrigeration would be the critical control point for egg packing if it was decided that there had to be at least one. Refrigerating eggs can slow the growth of microbial hazards, like Salmonella enteritidis, that might already be in the yolk.
Conducting a hazard analysis
When HACCP plans were required by the USDA Food Safety and Inspection Service for meat and poultry plants, the agency issued guidance for writing a HACCP plan and established a requirement that all HACCP plans must have at least one critical control point. Kelley-Astorga works with meat and poultry plants, who are regulated by the USDA, as well as egg packers who fall under FDA regulation, and she said that the different regulatory approaches have impacted the respective industries. Some USDA meat processors have more trouble completing a risk assessment than FDA facilities because they are used to being told what they have to do and they don’t challenge their inspectors because they fear that they are always going to lose. The FDA regulated plants are forced to think about their plans and justify and validate whatever their decision is. “If you have regulations that say that there shall be a critical control point, then people stop thinking. When you stop thinking and stop challenging your processes, then you make mistakes,” she said.
USDA changes
In the aftermath of the two massive egg recalls in 2010, the USDA’s Office of the Inspector General began an audit of the USDA’s shell egg activities in October of 2012. The audit looked at the activities of the Animal and Plant Health Inspection Service, Food Safety and Inspection Service and Agricultural Marketing Service as they pertain to the monitoring of the wholesomeness of table eggs for human consumption. The Office of the Inspector General released the audit report on November 30, 2012. Roger Glasshoff, national supervisor, shell eggs, USDA Agricultural Marketing Service, discussed the Office of the Inspector General’s findings at the United Egg Producer’s Board meeting held just prior to the International Poultry Expo.
The FDA holds regulatory jurisdiction for the safety of shell eggs from production to processing to retail. The USDA Food Safety and Inspection Service has regulatory jurisdiction for the sanitary processing and the ambient temperature during storage and transport. The Office of the Inspector General’s report makes 10 recommendations for improvement in the USDA’s activities regarding the safety of shell eggs (see side bar).
Egg packing sanitation
The third recommendation in the Office of the Inspector General report is that the Food Safety and Inspection Service collect data on the current state of sanitation at egg packing and processing plants nationwide. The Office of the Inspector General said that this data should be analyzed to inform decision making regarding any standards that need to be revised or enforced to ensure that consumers are protected and that safe products are being produced.
Time and temperature
The Office of the Inspector General has told the Food Safety and Inspection Service that time and temperature impacts on Salmonella enteritidis growth in the egg should be studied further and enforcement should be based on the results of the science. The Food Safety and Inspection Service has been tasked with developing and implementing a science-based shell egg temperature policy that assesses time, temperature and other factors.
Under an agreement with the Food Safety and Inspection Service, the Agricultural Marketing Service monitors the ambient temperatures in egg storage coolers in egg packing plants that have graders. Glasshoff said that the Agricultural Marketing Service doesn’t have enforcement responsibility; the temperature data is submitted to the Food Safety and Inspection Service. In 3.5 years of data collection, Glasshoff said that there were over 800 instances where cooler temperatures were over 45 F, with the highest temperature reported being almost 80 F. The USDA Food Safety and Inspection Service will send warning letters to egg packers if the cooler temperature exceeds 60 F. Glasshoff said that there has never been any other enforcement action besides the warning letters. The Office of the Inspector General wants the Food Safety and Inspection Service to develop an enforcement policy with civil and criminal penalties.
Real-time reporting
The Agricultural Marketing Service has agreed that its personnel will report egregious conditions that present a high risk or evidence of contamination or adulteration of shell eggs observed during Agricultural Marketing Service audits, inspections or grading activities. An interagency referral report, that is web based, was established and it provides real-time notification of the required agencies for reporting any observations that show a violation of the Food, Drug and Cosmetic Act. Glasshoff said that to date, the Agricultural Marketing Service had made 18 referrals and the FDA also has reported a few observations to the USDA using this new system.