SUBJECT AREA: SURVEILLANCE |
| STOP currently tracks outbreaks, clusters, and cases of foodborne illness that have been brought to its attention through its victims' hotline and other sources. When tracking foodborne illnesses, STOP has too frequently been thwarted by uncooperative state and local public health offices who deny that illness has occurred or are unwilling to release data to the public. Frequently, those offices are located in "agribusiness" states and their staff cite laws protecting food establishments from being identified as sources of contamination and/or agriculture disparagement laws to substantiate their claims that information cannot be released. How will this initiative work with uncooperative institutions? Will information be collected by the sentinel sites and through other initiative partnerships be available to the public? Will the initiative review state and local laws that impede food safety surveillance and communication and develop a plan to address these obstacles?. |
| Please discuss what type of traceback and on-farm surveillance you foresee. Will a chemical residue surveillance program for fish and other seafoods be initiated? |
| Who/what will each agency contribute to this Foodborne Outbreak Response Coordinating Group? Who will be in charge? Problems of jurisdiction under statutes? Any suggestions that all food safety activities should be under one Federal agency/one roof? |
| Is there another country with a foodborne disease surveillance system after which the United States could model its new, improved surveillance system? Or does the U.S. system already surpass other nations' systems? Do you anticipate ever being able to compare U.S. foodborne illness rates with those in other countries? |
| The report is comprehensive. However, there is no mention of insuring qualified and trained microbiologists are employed in public and private clinical laboratories whom are able to conduct surveillance and recognize outbreaks of foodborne diseases including new and emerging ones. Please explain. |
| How will the Agency(s) coordinate data sharing so that preliminary, possibly damaging information, is not available until properly reviewed and uniform decisions are made on cause of outbreaks and control strategies? How will this information be fed into research needs identification? |
| Where did the estimate of "6" for E. coli O157:H7 mentioned in the draft come from? In the area of surveillance, we would encourage expanding the arena to all enterohemorragic E. coli strains rather than limited to only O157. This could be achieved by verotoxin testing and will address the issue of new and emerging substrains. |
| How did you develop the list of six pathogens of concern contained in the draft? Please address individually why you left the following pathogens off the list of pathogens of concern: (1) Listeria, (2) Shigella, (3) Vibrio vulnificus, (4) Vibrio parahemeliticus, (5) Other vibrios, (6) Ciguatera, (7) Scombroid poisoning, and (8) Botulism. |
| Why isn't Vibrio vulnificus listed as a pathogen of concern, given that FDA documented that it killed at least 23 people last year along--a much higher number than the other ones listed? |
| What effort will be made to get quicker response of extensive "medical data" is being envisioned? |
SUBJECT AREA: INSPECTIONS |
| Our public interest law firm has already received the first reports of retaliation against corporate workers who alerted their superiors to the food safety consequences of intentional violations of the sampling requirements now in place. What are the specific obstacles to adopting corporate whistleblower protection and what evidence would FSIS consider sufficient to initiate efforts to overcome these obstacles? |
| A few weeks ago FSIS announced new import inspection procedures. Unfortunately, comparing reports of both the new and the old laws found in remarks at the announcement meeting, the FastFax, a Food Chemical News article and reports from front line inspectors, it is impossible to nail down what FSIS' actual policy is or was. We've asked for the written regulations but have gotten nothing. If this confusion exists in the field, consumers cannot feel confident that imported products are being inspected most effectively. Where can concerned consumers easily find written regulations so that we can understand and judge the adequacy of the policies put in place to protect us from contaminated imported products? |
| Since HACCP is being advanced on all fronts as the food safety control system of choice for the manufacturing and retailing of foods and HACCP emphasizes process control and documentation of process control rather than sampling, it would seem to make more sense to first certify state/foreign governments or third parties to perform inspection-based auditing or surveillance. The only mention of this in the draft Initiative seems to be where it states FDA should consider developing more Mutual Recognition Agreements with foreign governments. |
| When does FSIS anticipate moving away from animal by animal inspection so that resources can be better used? |
| Re MRA's. The public is very concerned about how "equivalent" is defined by federal agencies. For instance, we do not consider company-employee inspections to be equivalent to unbiased government inspection. Please be aware and please comment on such. |
| With apparent very little inspection, the seafood industry enjoys an increasing market share of consumer food dollars. With less than 25% of seafood facing any form of regulatory inspection and less of imported seafood being inspected, maybe we have an industry-based program that could be applied to all food production. Can you speak to what that industry is doing right to prevent foodborne disease? |
| How will the food safety initiative improve
the inspection of imported food products? How did you come up with a minimum inspection frequency for FDA-regulated food plants of once per year for hazardous products? That seems ridiculously low! How much will this food safety initiative actually increase the frequency of inspection at FDA regulated food plants? Please use the average inspection frequency of once every 10 years to answer this question? How will the Food Safety Initiative address the gaps in our food inspection system, including lack of inspection during transportation, storage and inadequate resources for inspections of restaurant and institutional food? Current FDA inspectors may visit a food plant one day, a drug plant or medical device plant on the next day. Will this initiative give FDA dedicated food safety inspectors? If not, why not? |
| We're very concerned with the implication on page 15 of the draft stating that FSIS inspectors, already in the plants, will be involved in inspecting non-meat foods. There is a recognized problem already of FSIS inspector shortages resulting in "less than continuous" inspections. Asking them to expand their duties to non-meat will further jeopardize the quality and quantity of meat inspections, already at a critical point It's appalling that the number of FDA inspections have dropped 58% from 1985. What has happened to domestic volume over this same period of time? |
| Secretary Shalala mentioned FDA's Seafood Inspection Program. Apparently new inspectors will be added to that program. What training will those inspectors receive and what exactly will be their function? |
| What does FDA plan to do to get the Food Code adopted in more states? |
| the CFA has supported
the developed of a HACCP-based food safety program on the
assumption that full inspection would remain in place until these
very new HACCP programs are shown to reduce foodborne illness,
i.e., it is working! We ask you to give high priority to increasing FDA inspections for seafood and maintain inspector force (USDA) for raw meat and poultry. If not--a big outbreak and/or public will condemn HACCP concept. |
SUBJECT AREA: RISK ASSESSMENT |
| Will there be any real attempt at a comparative risk
assessment between microbial pathogens and contaminants?
Specifically, will we use risk assessment to guide the allocation of
research and prevention funding to areas where we may reap the
greatest benefits? Since you are not excluding chemical contaminants from this food safety initiative, do you plan to continue your excellent yearly report and analysis of your pesticide reside surveillance? Consumers domestically and worldwide continue to view pesticide residues as serious health risks. These reports have been extremely useful in educating on the safety of the U.S. food supply. How will this initiative improve our estimates of foodborne illness cases? This information is critical to our efforts to set priorities and measure our progress in improving food safety. |
| Some organisms are present on entering a plant--but only sporadically. No testing program could hope to find it. How does HACCP deal with this problem? (Assume HACCP can prevent it from worsening.) |
| Was consideration given in the draft report to the possible link between specific farm management practices or animal husbandry systems and the existence of microbial hazards? How might this possible link be addressed through risk assessment and/or research? |
| Clearly,
shellfish is the deadliest food
source based on risk per serving. How many deaths do we need
before FDA will control products contaminated with Vibrio
vulnificus? What happened to FDA's proposal to require Gulf Coast oysters to be shucked by certified harvesters and clearly labeled "NOT FOR RAW CONSUMPTION" during the summer months? |
| Can you identify and/or clarify the chemical contaminants referred to in the Risk Assessment section? How are chemicals involved in the food safety initiative? |
| How soon will the research
and risk assement activities
planned under the Food safety Initiative translate into real food
safety benefits, measurable in terms of fewer deaths and illnesses? Given limited federal dollars, doesn't it make more sense to focus risk assessment on identifying the foods and methods of preparation that represent the greatest risk to consumers, rather than on trying to develop dose/response numbers? |
| What attention is being given to the problem of identifying potential future foodborne disease incidents arising, e.g., from known microorganisms whose role in foodborne disease might not be apparent. (In other words, what is the next cryptosporidium? What else might be associated with E. Coli? What about cyclospora? |
SUBJECT AREA: EDUCATION |
| Is there more information on the USDA, FDA, CDC Food Safety Conference in June? |
| Do we need to go beyond multilingual thinking to some type of nonverbal university message? |
| With all the cold food prepared and served (seafood salads, tuna salads, etc.) Will the high risk in preparing these foods be assessed and communicated? The blanched celery mixed into these salads is a very high risk item. Chilling all items before and after preparation reduces risk according to an expert in food safety. |
| With the reports that more than 80% of foodborne illnesses stem from improper food handling, it would seem that education should be a primary focus of the Food Safety Initiative. However, it seems that in this draft that the multifaceted nature of education has been lumped under one responsibility whereas pathogen reduction has been nicely segmented into its component parts. How do you see that the education needs might be more effectively segmented, i.e., consumer, retailer, producer, farmer, handler, transporter)? Surely one office cannot offer maximum impact on all of these highly diverse components. |
| The draft uses the word "should" in regards to improving consumer education and retail, food service and institutional education. And we agreed it should. However, when it comes to veterinary and producer education and industry education in the transportation area, you use the word "could", when talking about developing and implementing education programs. WHY? Effective education occurs during the "early years" or "early stages" to effect the best results, in this case safety. |
| What will this initiative do to educate doctors about how to identify foodborne illnesses, like ciguatera and others with nontraditional symptoms and to increase reporting of foodborne illnesses? |
| We are currently working with the food service industry (restaurants, hospitals, schools) on educating this segment of food safety. We find this critical segment significantly lacks proper education. What support can we receive for these educational forums, such as speakers, and what plans are being made to educate this segment as more and more people are eating out or bringing prepared food back to this homes? |
| What role do you see for the USDA's Cooperative Extension Service in education? Do you see an expanded role or perhaps less of a role with the creation of an "education alliance?" |
| We are disappointed that, up to this point, this initiative has not mentioned the subject of ionizing pasteurization or food irradiation. It is a well accepted fact that this technology can reduce or eliminate pathogens in foods. This initiative appears to be an ideal method to increase awareness of the advantages of this technology and to encourage increased utilization of this pathogen reduction method. A consumer education program is needed. Research studies have demonstrated increased consumer acceptance when they are provided with the facts. Will the education portion of this initiative address ionizing pasteurization of food? When will FDA/CFSAN act on the petition to extend approval of irradiation to all meats? |
| Why not begin emphasizing and encouraging use of one of the most efficacious food safety tools--irradiation? |
SUBJECT AREA: RESEARCH |
| There is a great deal of discussion about research in this discussion draft. To what extent will the academic research infrastructure that currently exists be utilized? |
| Why were these particular pathogens chosen? In the section on sources of foodborne condemnation, what was the decision criteria used? There are many more pathogens so why were these chosen? |
| Given that the top scientists working on transmissible spongiform encephalopathy (TSE's) acknowledge that what we know about this disease condition is so little when compared with what we need to know and that a top researcher, Dr. Gibbs, believes that every species could spontaneously develop a TSE: Why are pigs and poultry not included in FDA's ban on ruminant feed? Why are pigs and poultry excluded from FSIS' and APHIS' surveillance of brains of animals found with CNS? Is there or are there plans for a coordinated task force on TSE's from which information would be available to the public? |
| So far, member of the panel have discussed on-farm research in relation to chemicals and drugs. How will the initiative address correlations between animal husbandry and foodborne pathogens? FSIS' authority at the farm level has traditionally been a contested issue, yet the farm is an important link in the food safety chain. Do you anticipate that animals intended for human consumption that carry deadly foodborne pathogens will be quarantined or reclassified as not suitable for human food? |
| Scientific organizations worldwide have endorsed irradiation as a crucial tool to prevent foodborne disease. Why isn't this technique being promoted by USDA and FDA? |
| Food irradiation (low dose) has been shown to be an effective process to kill pathogens. Could federal agencies act to speed approval and implementation of this process and consumer education of its availability and safety? |
| Will the initiative facilitate both public and private research and efforts to develop new technologies and interventions and the necessary laboratory testing and commercial trials need to validate such pathogen reduction tools? |
| Low levels of microbial contamination can be dangerous, i.e., E. Coli O157:H7 in apple cider. Cost of detection techniques is high and throws small businesses out on their ear. How much research/surveillance is being done to find infective doses and relating this dose to economically possible preventive/killing technologies. |
SUBJECT AREA: COORDINATION |
| Where is APHIS? What work on preventing the problems from occurring is being planned? For example, can we go to "salmonella free?" |
| Wouldn't combining the functions of the many agencies
involved in food safety into a single agency eliminate the need for
and expense of coordination among the federal agencies?
Wouldn't this also help the government rationalize the system of
delivering inspection and other services? Under the Food Safety Initiative are there any plans to coordinate the agencies' approach to controlling Salmonella enteritidis in eggs? With respect to raw molluscan shellfish, existing partnerships with the states and industry haven't worked to eliminate the worst food safety hazards. How will this initiative improve this situation? With respect to implementation of the Food code, existing partnerships with the states haven't worked to ensure the adoption and enforcement of minimum food safety standards in restaurants. How will this initiative improve this situation? |
| Coordination "Current Thinking Point," i.e., "enhancing the basic infrastructure for foodborne illness" Recognizing that state resources available for surveillance/investigation continue to dwindle in spite of the fact that most of us see the public health infrastructure as our first line of defense in an "early warning system" would suggest states be encouraged to pool their resources where possible and set up state alliance or regional labs and investigative teams to help facilitate this goal. I would appreciate your comments. |
| In Mr. Mande's presentation he noted that industry is a source of information for identifying/controlling problems; however, no mention is made of industry's role in problem resolution. Why not? |
SUBJECT AREA: STRATEGIC PLANNING |
| How will the FDA be spending the $23 million targeted for food safety included in the President's budget? |
| Several of the major themes across the presentations are "improved interagency cooperation" and "making changes in the basic infrastructure for food safety." Why not combine the relevant parts of USDA, FDA and EPA into an independent food safety agency? This could be a proposal put forth in an action plan. We all know it would require legislation. |
| Since no added dollars are in the budget for this safety initiative and since it is unlikely that "user fees" will be authorized--leading to a cut in budgets, are you considering (in addition to beefed up active surveillance for foodborne illness) targeting 2-3 known risky foods, i.e., ground beef, juice, seafood, for which you would increase inspection, build traceback to source and retail surveillance? Without such focus, consumers will not view this initiative as successful. |
| Will this initiative actually increase the number of FTE's for food safety inspections at FDA? |
| Much of the discussions today have focussed on working toward eliminating the source of foodborne pathogens in our food supply. Since one of the most common causes of foodborne illness is undercooking and in light of the ever increasing availability of "partially cooked" and fully cooked" food products, what steps will be taken with this new food initiative to ensure that federal minimum cooking regulations on these types of products have been met? Will funds be made available to evaluate currently available, scientifically based tests which can ensure that cooked poultry products, hamburger products, and imported meat products, meet current minimum federal regulations? |
| Is drinking water (or water in general) a full partner in this program since the regulatory programs of food and water are so different? If so, how will the relative source of disease distribution be addressed and how will the vast differences in inspection be resolved?--and the questions go on |
SUBJECT AREA: MISCELLANEOUS |
| Suggestion--make hard copies of slides available, plus Glickman's and Shalala's remarks. |
| What is EPA's role in the initiative? |
| Now that the comment period for the ANPR on transportation and storage of potentially hazardous foods has closed, what is the current thinking regarding the regulatory approach to take? Performance Standards? HACCP Systems? |
| The discussion draft appears to be very comprehensive. Can you describe how the implementation of the Amendments to the Safe Drinking Water Act, which passed Congress last year, will "fit in" to this new initiative? |
| We're seeing an alarming increase of animal reservoir pathogens contaminating fruit and produce, what federal agency is responsible for the safety of manure used in farming and gardening? Is there one? What federal agency is responsible for the safe production and harvesting activities that discharge wastewater and solid waste? |
| Most of the comments this morning and most of the budget allocated to this initiative is directed toward inspections, surveillance and other detection methods. Why is prevention not the centerpiece of this initiative? |
| More than 75% of the discussion was about detection, recall, and identifying the problem. When do you talk about prevention methods? |
| The Food Animal Residue Avoidance Database (FARAD) provides information to veterinarians and animal owners to help them combat and prevent pathogens which cause foodborne illnesses and prevent violative chemical residues in food from animals. FARAD has been funded on a competitive year-to-year basis by USDA's Extension Service. Since FARAD is so important to a first line of defense in the food safety arena, can that program be more adequately funded on a permanent basis by other agencies within USDA and FDA? |
| I think enforcement is an important area to be added to the areas already identified. Enforcement action is needed to assure that current and future regulatory food safety requirements are complied with. |
| Excellent Draft. Missing is a focus on science-based technology for killing pathogens in food, especially since they are resistance to treatment. Also missing a section on how coordination between industry, academia, and government on how food safety policy procedures work in sync with food industry and their suppliers. Can you put copies of slides up on the "net"? |
| Animal production generates 2 billion tons of manure each year. It is rich in nutrients and pathogens. In most cases manures are wasted, causing multiple pollution risks. EPA under the Clean Water Act (Section 503) has done the science-based risk assessment to regulate human manure/biosolids in agriculture. Why do we carefully regulate the tiny of amounts of biosolids used in agriculture and ignore the huge quantities of animal manure? EPA and USDA should coordinate a response to the manure management issue. Responsible recycling of animal manures should be a national policy. Our degraded soils need these organic resources for long-term sustainability, but we must address nutrient leaching and pathogen problems to protect our food and water. |
| There is overwhelming scientific evidence that the exposure of food to ionizing radiation is an almost certain way to eliminate harmful pathogens. This technology is used in 47 countries, and NASA and many U.S. hospitals use irradiated foods...yet there is no work going on in research or testing by USDA....and no mention of it in your report. Why are you keeping this life saving process from being used? |