Michael Ambrosio, Food Marketing Institute
Within the bill, FMI supports the requirement that every registered food facility conducts a risk assessment and makes and implements a food safety plan. He praised the bill for basing the frequency of inspections on the level of risk of each facility. He seemed worried about the traceability provisions and asked that retailers buying directly from farms be exempted from the traceability section.
About the user fees, he said:
We are willing to support a fair registration or user fee provided that it is utilized by FDA in a transparent and accountable manner to improve the safety of our food supply through means such as conducting research and consumer education programs.
That's a very interesting stance, because I was under the impression the user fees would go to pay for inspections, not consumer education.
About the FDA's ability to call for mandatory recalls, he said:
We believe that FDA should be given the authority to mandate a recall in only those cases where a company responsible for adulterated food does not act promptly to recall a food that presents a reasonable probability of causing serious health problems or death. This authority would allow FDA to act when a firm refuses to recall product or when a company is no longer in business and is not able to conduct the recall. Penalties and other punitive measures should also be limited to those responsible for the adulteration.
Overall, he seemed concerned that the FDA would misuse authority given to it, pointing out the case last summer when the FDA thought tomatoes caused problems when it was really peppers. He felt it would have been unfair if the FDA had increased authority to penalize the tomato industry when it was in fact innocent. He said:
The draft bill grants FDA extraordinary new powers to suspend or halt the production and distribution process of food products for a variety of reasons while also increasing the ability of the FDA to assess fines for infractions. New powers and penalties must be complemented by a hearing and appeals process that is fair, reasonable, and quick. Penalties and enforcement measures should be available to deter and punish those that knowingly violate our food safety laws.
Last, he was not very keen on the country of origin labeling provisions in the bill, nor on the whistleblower protections.
Pamela G. Bailey, Grocery Manufacturers Association
GMA supports "much" of the bill. However, they want to change the traceability section of the bill. Essentially, the food industry finds this burdensome and they want it to be limited and delayed if possible. They are also concerned about the FDA's authority to call for mandatory recalls - they want to limit this authority to the most senior officials at FDA and only in the most extreme, serious circumstances. She said "we are not opposed to all fees" and talked about compromise, which makes me think that she's probably not thrilled about the $1000 user fees as they are currently outlined in the bill.
Caroline Smith DeWaal, Safe Food Coalition
She began saying "we believe this is a strong bill." She recommends additional strengthening of the bill by requiring companies to test for pathogens and report the results to FDA. On the inspection schedule, she called for even more frequent inspections than are provided for in the bill, especially for high risk facilities. She called the registration fee "quite modest" and noted that the fees will cost industry less than the price of an outbreak caused by contaminated food.
Tim F. Jones, MD, Tennessee Department of Health
He began by praising the traceability aspect of the bill and describing the need for it in dealing with food safety outbreaks. He noted that he's particularly concerned about foods that are eaten raw (like produce) and called for standards for growing and harvesting produce. He also called for allowing the FDA to adapt to changes in technology so they can improve with time as the technology improves. He said that one of the biggest problems during an outbreak is the lack of information sharing between agencies and he called on FDA to work together with state and local agencies and with other federal agencies. To solve this, he said the agencies require both the authority and the ability to share information. Last, he called for giving the FDA and their state and local partners adequate resources to meet the mandate of the bill.
Thomas E. Stenzel, United Fresh Produce Association
He wants "mandatory, science-based" standards for produce. He said produce safety standards must allow for a commodity-specific approach based on best available approach, consistent across each commodity whether domestic or imported, and must have sufficient federal oversight. He also called for "farm-to-fork traceability." He said he has an electronic traceability system underway, but he's afraid that the way the very prescriptive requirements in the bill will actually derail it. He wants Congress to add flexibility to the bill in that area. He also noted that we need to double our consumption of fruits and vegetables as a nation and we can't afford to be afraid that our fruits and veggies aren't safe.
Q&A
Pallone began by asking DeWaal how the preventive controls in the bill will make food safer. She replied that the systems that are going to be applied in the bill are well tested. She said her group has watched the implementation of HACCP systems (Hazard Analysis Critical Control Points) in the seafood, beef, fish, poultry, fresh juice, and several other industries. The problem with the approach taken until now (which the bill would fix) is that they've tried to apply these systems one by one, industry by industry. She said these systems are needed across the board. Even though the HACCP systems are designed by industry but the government can use them to go in and conduct inspections that are more meaningful than inspections today. What she means is that because the industry will have analyzed in advance where the risk areas are in their processes, then the inspectors can look through the analysis, verify they make sense, and then focus on the most critical areas of the manufacturing processes during their inspections. Pallone asked if the others on the panel agree that HACCP is important and all said yes.
About access to records, the bill said that food manufacturers must keep records that the FDA can see in an outbreak or an inspection. He asked Jones if that is helpful. Jones replied that it's important, and it's also important for the FDA to be able to share that data with other agencies. He gave an example where during one outbreak, the FDA had names and phone numbers of people who had consumed a tainted food but thought they were not allowed to share that information with other agencies so that the people could be called and warned not to eat the food. Then DeWaal answered the same question, saying that the ability to access records gives the inspectors the ability to see what has happened in a plant not just on the day of inspection (as they do now) but over a period of time. She said this will allow them to see where the company has faced challenges and how they've addressed them.
It was Deal's turn to ask questions next. He asked Stenzel if he saw a potential of this bill creating overlap between the FDA and the USDA. Stenzel said no, but emphasized that the agencies should work well together.
Next he asked about Good Agricultural Practices (GAPs). He said his understanding is that GAPs are the primary method of preventing problems on the production level and asked Stenzel if the GAPs needed to be updated. Stenzel replied that yes, its important. He also reiterated what he said in his testimony that just 5 commodities are responsible for the vast majority of outbreaks so he hopes that the regulations focus on the foods that are the highest risk.
Deal then asked Bailey about her request that the FDA complete the studies and pilot projects called for in the bill before going forward with making any rules that are mandated across the board. She replied that yes, this is her request for the traceability requirements. Deal said that makes sense. He then asked Stenzel about traceability as the produce industry has also begun efforts to put a traceability system in place. Stenzel said that it's very difficult but he thinks it is very worthwhile. He also said:
But some of the language in the bill gives us cause for concern. We don't think what we're doing would necessarily meet the mandate of this bill. We want the FDA to learn more about each industry and the technology before making the rules.
Last, Deal asked Stenzel about the provisions in the bill for foreign producers that import food to the U.S. Stenzel felt the bill's requirements were appropriate. Deal concluded by asking Stenzel if he represented any organic producers and Stenzel said yes. Quite honestly, I worry about Stenzel and his testimony because even if he does represent some smaller farms or some organic farms, he is calling for things that will hit the little guys much harder than the big guy (which he acknowledges in a later question).
Dingell came next, and he was quite a bit nicer and less scary than he often is when he questions witnesses. He directed all of his questions at Bailey..
Dingell: Am I fair in stating that FDA is so underfunded that they can't protect industry or consumers?
Bailey: Yes
Dingell: As a result, they have been unable to ensure safety of nations food supply?
Bailey: Yes. For example, FDA has not been able to update Good Manufacturing Practices since 1986.
Dingell: Has FDA's science base eroded?
Bailey: Yes
Dingell: And the FDA's information technology is inadequate?
Bailey: Yes
Dingell: FDA has not been doign acceptble level of surveillance and research?
Bailey: Yes
Dingell: They haven't done enough inspections over the years. (he give stats)
Bailey: That's an accurate statement, yes
Dingell: And I'm sure you agree that FDA needs additional resources to do their job?
Bailey: Yes
Dingell: I'm troubled about foreign people who deliver food into the U.S. FDA doesn't have the right number of inspectors at the border, do they?
Bailey: No, they do not.
Dingell: I'm told they only inspect about 1% of the food coming into this country and that games are played where food is turned back with the result that they go out and come back in another port. Are you troubled about that?
Bailey: Yes.
Dingell: I'm also troubled that they don't have an unerstanding with other agencies like customs, so often their [customs] folks are at the ports and there's no FDA people there. We oughta make sure they oughta work together, is that right?
Bailey: Yes
Shimkus came next. He was just as grumpy as ever, and he wanted to nitpick over language in the bill. He doesn't like the way the bill specifies when recalls can be mandated or subpoenas are allowed. He asked whether the language was vague. The three industry representatives agreed. The CSPI woman (DeWaal) called for the language to stay unchanged to give the utmost protection to consumers. Jones began by agreeing with DeWaal and then got fed up and said "I'm a physician, not a lawyer. My tendency is to err on the side of protecting the public's health."
Shimkus then went off on the language about the requirement for produce safety standards which should specify "minimum" safety standards. He felt that we should not be calling our safety standards "minimum." It reminded me of the part in Office Space where Jennifer Aniston gets in trouble for only wearing the minimum amount of flair. Stenzel agreed with him that we shouldn't be looking for minimum standards - intead we should write standards that all producers have to follow.
Last, he complained to Bailey about the baby formula provision in the bill, and neither he nor Bailey could figure out why there might be any need for increased regulation of baby formula. Perhaps somebody could call Shimkus' office and ask the staffer who answers the phone to tell him about all the babies in China who died because of melamine in baby formula.
Next up was DeGette, who is a major proponent of traceability. As she put it, she doesn't see what good any mandatory recall authority does if nobody can trace where the food came from in order to figure out what to recall. She asked DeWaal about the bioterrorism act's traceability provision that requirers companies to trace one step forward and one step back in the supply chain. She asked if that was enough and DeWaal said no. Jones added that it's such a large production chain that if one step is missing then you don't know where the food is from. DeGette asked the three industry folks if they agree with the concept of traceability even if they don't like the bill's specifics. All said yes. DeGette ended saying, "We need to have traceability but we can't have a one size fits all traceability system or technology but the key is they are interoperable."
Buyer was the last person to ask questions but it seemed like he was mainly upset that food safety was getting more attention than a drug safety issue he cared about. He ranted on and on about the exemptions provided for in the bill for farms selling directly to consumers and restaurants. Here's a taste of his rant. I tried to get every word but might have missed some:
When I look at sections 106 and 107 we have an all in and then under treacability we have some exemptions. So I think about small businesses and I worry. So when we think about access to records so we say there's a requirement with regard to restaurants. Then do we concern concession stands? Does this apply when you go to a college football game? High school? Little league? We make deer chili at little league stores. How about conveninece stores. You pull into that mom n pop gas station and they've made something - you can get elk sausage. Do we need a better definition of who's in and who's out?
Stenzel replied that he does not think it has to do with scale because even the smallest producers can cause a food safety outbreak. Buyer went on to say that he thinks the major cause of foodborne illness is from food handling (i.e. a person goes to work at a sandwich shop and they leave the mayonaise out until it goes bad) and that we are just scapegoating the manufacturers. He kept on ranting until his time was up, and then the hearing was over. |
