Revising California Good Manufacturing Practices in the 21st Century

Speech given by Laurie Girand at the GMP Modernization Public Meeting, San Jose, CA

August 5, 2025

My name is Laurie Girand, and I am a member of Safe Tables Our Priority. S.T.O.P. is a nonprofit of victims of foodborne illness, their families and friends and likeminded individuals concerned with pathogens in our food supply. S.T.O.P. advocates the elimination of pathogenic contamination in food.

Some of our organization's members are:
- people poisoned in multiple unpasteurized juice outbreaks, where less-than-sanitary processing failed to prevent deadly microbial contamination
- people poisoned by sprouts, in which the growing process exacerbates underlying contamination; and
- people poisoned in mixed lettuce outbreaks, in which the most basic GMPs were simply ignored.

We want everyone here today to understand that the foodborne illness we want to prevent is not just a little diarrhea. It is a very real poisoning of the body with foreign organisms, known in laboratories as biohazards. These organisms and their toxins can be lifethreatening to children, the elderly, and people that are immune-comprised, including pregnant women. In some outbreaks, children 5 and under make up as many as 50% of the detected cases. Most young children are unable to contain the bloody diarrhea that virtually explodes from their rectums. They scream in agony, begging their parents to help them. Babies that survive birth with Listeria infections may be left with lifelong disabilities.

We all need to be working from the same facts, and the facts are these. Epidemiology has concluded that initial contamination can come into a plant on raw materials, either because they were contaminated on the farm or in transport. Epidemiology has shown that pests in the vicinity of an open plant can also be a source of initial contamination. Epidemiology has shown in retail environments that sick workers can also be the initial source of contamination.

Once contamination is in the plant, studies have shown that organisms can be aerosolized or adhere to equipment, exacerbating cross-contamination. Organisms can be spread from a few raw materials throughout a lot by contaminated water. And the size of a lot or batch really matters; one contaminated apple can spoil a hundred gallons, a thousand gallons or ten thousand gallons of juice. Contamination can also be amplified through a lack of temperature control, either in the plant or outside the plant, in transportation.

With these facts in mind, Safe Tables believes that revisions to the CGMPs must take into account three key control points: the initial contamination of the food with pathogens, cross-contamination of one food to other foods or an entire batch, and the growth of pathogens to higher levels within any contaminated food. CGMPs must be applied uniformly to processors whether large or small because food poisoning is no less deadly if it comes from a smaller processor. CGMPs must be clear and intelligible to foreign processors. In order to reduce environmental contamination risks on the farm, in-field processing should be restricted exclusively to the processing required for harvesting; all other processing should take place in as enclosed, controllable environments as possible.

S.T.O.P. believes the following 10 areas must be addressed:

1) Raw material pathogen testing. A popular adage is "garbage in; garbage out" and with food this holds as true as ever. Initial contamination coming into a plant on raw materials has been a source of many outbreaks. Current CGMP recommendations that processors obtain "raw materials and other ingredients under a supplier's guarantee of certification" are not scientifically supported prevention methods. I might add that my own daughter was poisoned under such a guarantee, which proved to be worthless. Incoming raw materials must be tested.

2) Transportation. Transport affords opportunities for initial contamination of foods and the growth of organisms. Trucks used to haul manure or animals can then be used to haul produce. Clearly, vehicles used for the transfer of animals, animal meats or animal byproducts should be prohibited from transporting produce or produce products. Truck beds should be steam power washed to sanitize between food loads. In addition, the temperatures at which fruit and vegetables in warm climates are transported encourage the growth of organisms. Post-processing products should bear temperature-abuse indicators, so that consumers and retailers can be aware if the system has failed. On refrigerated vehicles bearing foods, records of temperature variations should be automated.

3) Worker Health and Hygiene. Workers represent a potential source of initial contamination. S.T.O.P. believes that current CGMPs leave too much room for interpretation. Gloves must be mandated. With emerging diseases such as SARS so easily transmissible, we believe that food workers that travel to other countries should be required to wait for up to a week after returning to the U.S. before working with food again.

4) Water quality. Water can be a source of initial contamination, but also contributes to the spreading of organisms within a plant. FDA simply must develop a scientific definition of water quality and stop using phrases such as "the water supply shall be derived from an adequate source" and "shall be safe and of adequate sanitary quality." Temperature settings must be specific to keep produce from absorbing pathogens from water. The quality of water and ice that come into contact with food must not only prevent microbial contamination but also be high enough that sanitizers actually work. Therefore, the quality of water in use over time must be tested periodically.

5) Small batches and lot sizes. One of the key factors exacerbating our large, multi-state outbreaks is the "super-sized" batches developed at large processing facilities. FDA must encourage processors to create small batch sizes and to sanitize equipment between batches. This single measure will dramatically reduce cross-contamination. S.T.O.P. believes that to the greatest extent possible, foods from a single farm, orchard or seafood harvest should be packaged together, and not mixed with those of other farms, etc. They should then be shipped to as few retail facilities as possible. Doing so would dramatically reduce the sizes of outbreaks, the numbers of illnesses, and the difficulty of traceback.

6) Record Keeping and Validation. Current CGMPs recommend that processors have proper equipment that take measurements, but they are unclear as to what should be done with pH, temperature, sanitizing and other data. Food processors should be required to document control steps taken for minimizing the potential for contamination and growth of organisms.. Proper record keeping should be supplemented with periodic verification steps; for example, with a routine sampling program. Key elements of such record keeping would be:
- Written SSOPs;
- Written records for sanitation between batches;
- Validation of control measures;
- Audit program

7) Final product pathogen testing. Raw or undercooked produce products that are chopped or mixed, such as salsa, cole slaw, guacamole and salad mixes, should be subjected to final microbial product testing, as should raw or undercooked dairy and seafood products. That raw dairy products are available to consumers and can go untested under federal regulation in the 21st century is a scandal. If a company cannot afford the testing, it shouldn't be in the business.

8) Traceability and Accountability. All facilities must keep records of the sources of raw materials, the destination of final products and information about which raw materials ultimately went where. When an industry visits multiple, repeated outbreaks on consumers, FDA should mandate that all the products of that industry bear warning labels until FDA can assure that those foods are as safe for consumption as the average food.

9) Inspection. As a farmer once told me, "You get what you inspect, not what you expect." FDA needs to stop treating regulations as though the work is done once the document is printed. That's just wishful thinking.

10) Certification. Processors should be required to prove that they are aware of current regulations and food safety guidelines or they should not be in business. The government needs to create a system for ensuring that fly-by-night operators can't sell food. Certification of food safety education and training should be required as a condition of commerce.

I would like to close with this quote from Marc Isaacs, who ran an unpasteurized orange juice company in 1998.

… I would encourage everyone, each and every processor, to do their best to upgrade the safety of their product.

In 1998, Mr. Isaacs attended a technical workshop where he described in great detail the experiments his company was conducting to find new ways to improve the safety of unpasteurized orange juice. Within 8 months of this recommendation, Sun Orchard's orange juice would be responsible for the single largest outbreak of juice ever in the U.S. Over 400 people would be sickened and one person would die. Incredibly, despite Mr. Isaacs' advice to others, Sun Orchard's plant was found to have multiple strains of Salmonella. Two months after the outbreak, FDA would allow Sun Orchard to begin processing again, and four months after the outbreak, Sun Orchard would again recall thousands of gallons of juice.

In the context of hindsight, I believe that Mr. Isaac's situation serves as a warning to us; we cannot afford to treat CGMP improvements lightly nor can we move quickly enough to implementation. People's lives and well being, and those of children in particular, hang in the balance.

Thank you very much.