|Opening statements were made by Rep. Pallone (D-NJ), Rep. Deal (R-GA), Rep. Waxman (D-CA), Rep. Whitfield (R-KY), Rep. Dingell (D-MI), Rep. Shimkus (R-IL), Rep. DeGette (D-CO), Rep. Buyer (R-IN), Rep. Barrow (D-GA), Rep. Burgess (R-TX), Rep. Harman (D-CA), Rep. Blackburn (R-TN), Rep. Christensen (D-VI), Rep. Murphy (R-PA), Rep. Green (D-TX), Rep. Barton (R-TX), Rep. Sutton (D-OH), Rep. Rogers (R-MI), Rep. Baldwin (D-WI), Rep. Gingrey (R-GA), Rep. Braley (D-IA), Rep. Murphy (D-CT), Rep. Castor (D-FL), Rep. Eshoo (D-CA), Rep. Schakowsky (D-IL), Rep. Capps (D-CA). All except Shimkus said they were for food safety reform. Waxman, Pallone, Sutton, DeGette, Stupak and Dingell were sponsors of the bill so they are obviously for it.
Deal was concerned about the user fees and frequency of inspections in the bill. Whitfield was upset over the risk-based inspections for low risk facilities, the traceability requirements, and the power given to the FDA for recalls and obtaining company records. Shimkus was grumpy over the whole thing in general and he recited some Republican talking points about big government. Buyer wanted a more integrated effort for food safety, suggesting a single food safety agency that combines the current duties of FDA and USDA (Eshoo brought that up too).
Barrow called for mandatory testing for pathogens and reporting of results (yay!) to be added to the bill. Burgess was worried that the timeframe given to the FDA and industry in the bill would be hard to meet. Blackburn said "You can't inspect your way to food safety" and stated concern about the growth of bureaucracy (Barton repeated this concern). Murphy (R-PA) wanted to make sure that the bill won't increase prices for consumers and doesn't want the traceability to burden companies. He suggested that perhaps requiring reporting of test results to the FDA may result in companies doing less testing (Capps agreed). Green worried about requirements for imports to be tested in FDA labs as there are many ports and few FDA labs. Rogers complained about the user fees. Schakowsky and Capps brought up antibiotic resistance in livestock, which I don't believe is part of this bill but there is another bill in Congress on that sponsored by Louise Slaughter.
Chairman Waxman remarked on the cost of the registration fees to the companies being regulated by the bill. The bill requires food facilities (not farms and restaurants) to pay $1000 per facility per year. Waxman rightly pointed out that industry lost far more than that in the peanut/salmonella recall and so it's comparatively a bargain to them. He also said that the fees do not cover the entire cost of the bill and the government will be making up the difference.
Then he said:
I also awnt to address another concern I have heard: the presence of FDA on farms. FDA has always had authority over food on farms. FDA has generally relied on state and local authorities for food safety oversight on farms, because they have a strong on-farm presence.
However, the large number of recent outbreaks that have originated from food contamination on farms has shown us that more oversight is needed. FDA must develop national science-based safety standards, to reduce incidents of on-farm food contamination.
I am confident that farmers have nothing to fear from this bill. The bill calls for the FDA to set its standards through regulations, which means that the FDA will go through a public notice and comment process. Thus, stakeholders will be able to work with FDA to ensure that the best possible standards and practices are adopted.
I am not as confident as he is, but whatever.
Margaret Hamburg's Testimony
Hamburg, the new commissioner of the FDA, focused on 3 questions:
- First, does the legislation support a new system focused on prevention?
- Second, does the legislation provide the FDA the legal tools necessary to match its existing and new food safety responsibilities?
- Third, does the legislation provide or anticipate resources for the Agency to match its responsibilities?
All in all, she seems happy with the bill. She thinks it has the right focus, gives the FDA the needed authority to do its job, and gives the FDA some needed resources to do it. However, she was concerned that even with extra money, it would be hard for the FDA to hire and train enough staff to increase inspections to the levels called for in the bill. FDA also wants flexibility to change the inspection requirements based on data they receive as they go about which foods are the highest risk and how frequently inspections are needed. Last, she requested that the FDA would be allowed to accredit third parties to perform inspections instead of having FDA staff perform all of the inspections themselves.
Pallone began by asking about the 2002 Bioterrorism Act that required facilities to register once with the FDA but not re-register. He asked how that was working and how she felt about the changes to that is this bill that requires annual registrations and fees. She was in favor of the changes to the 2002 bill in this act, both annual registrations and fees.
Next up, Whitfield asked her about differences between a Senate food safety bill and this one. The Senate bill was more specific in the cases when the FDA has the authority to mandate recalls or access a company's records. This bill says an article of food can be recalled if it "may cause adverse health consequences." The Senate bill says there must be "reasonable probability of serious adverse health consequences or death" before a recall may be mandated. He asked which she thought was more appropriate (hinting that he preferred the Senate language).
She replied that she understands the concern and thinks there's an opportunity to make the wording more precise. The FDA would never seek a recall without the reasonable expectation that there was serious adverse consequences or harm related to that product. On the other hand, she does not want the language to be so limited that the FDA lacks flexibility to act in an emergency situation. (Whitfield says he agrees)
About records, the House bill gives FDA access to records in any situation, whereas the Senate bill specifies access only when the "FDA has reasonable belief that an article of food represents serious adverse health consequences or death." Hamburg was less inclined to agree with the Senate language here because she said access to records is important during inspections. The FDA will want to know what has been going on in the facility in the recent past in addition to seeing what's going on during the time of the inspection. She added that if we could have done that at PCA, we could have seen documentation of contamination several years earlier.
Whitfield finished by asking about antibiotic use in livestock and the problem of antibiotic resistance. Hamburg replied that that is a huge concern of hers.
Next up, Dingell spoke, asking a series of quick yes/no questions. The following is all paraphrased:
Dingell: Are inspections an important part of finding and addressing food safety problems?
Dingell: FDA does not have a good record when it comes to inspecting facilities (he gives stats). Was that enough inspections you did last year? How many should you do and what resources do you need?
Hamburg doesn't know so he says he'll send her a letter with that question that she can respond to.
Dingell: Would you support the bill's requirement for more frequent inspections?
Hamburg: We need more frequent and smarter inspections and can't rely simply on inspections for a safer food supply.
Dingell: How much do you need to do this properly in terms of personnel and money?
Hamburg: It's a complicated answer, but a lot more money.
Dingell: With the new inspection requirements, the FDA will need new resources?
Dingell: The president has requested resources ($259million)?
Dingell: The President's intent is that these funds ($168 million from the budget, and the rest from fees) would be uesd to increase the number of inspections?
Hamburg: Yes, as well as other components of a comprehensive food safety system.
Dingell: President's request did not include any new requirements that will come from our bill?
Hamburg: It included some components but not all.
Dingell: Some people with to prohibit using fees to cover the cost of inspections. Do you agree with them?
Hamburg: We need registration fees to enable the agency to do inspections.
Dingell: Can you state how many people import products to the US?
Hamburg: No, and this bill will help us there.
Dingell: The reason is they currently aren't required to register?
Dingell: Isn't it important for the FDA to have an accurate up to date account of who they are?
Dingell: These people (those who handle imports) aren't required to have any specific training for food safety?
Hamburg: Yes, and we would like to make sure they follow standards or guidelines, the same as domestic food production.
Dingell: The bill draft includes a requirement for importers to register with FDA and that Good Importer Practices are maintained as a condition for maintaining registration, do you agree?
Hamburg: I want importers to be registered.
Buyer was next. He asked whether she supported FDA's ability to trace foods more quickly in an outbreak. She said yes. He said: Since you appear to be endorsing the bill, do you also support the FDA's ability to increase inspections? She replied that we need to do more inspections, but also recognize that it isn't inspections that will get us to the food safety system we need. She said it's also instituting preventative controls and shifting the way we think about food safety.
Buyer asked if she wants the authority for mandatory recall. She said yes. Once it's been discovered, he asked, do you want authority to destroy the contaminated food? She answered that it depends. If the food can be reprocessed and sold to consumers in a safe way she would prefer to do that. If not, then the food should not be sold to consumers.
Next up, DeGette. She mentioned the traceability requirements of the bill and asked about the feasibility of carrying them out in terms of technology. Hamburg agreed this was important and called for interoperability in a tracking system "because it involves many players along a lifecycle of a product, and that's one of our challenges to work very carefully with industry and with the different components of the food production system, to do it in the context of public meetings and open exchange, but that should be our goal." DeGette replied that that's what the bill does. She said "Different sectors of the food industry have different types of requirements, and we're not saying we have a one-size fits all."
The she asked, "Do you think there's an economic case to be made to industry for better traceability?" Hamburg replied:
Absolutely, because with this capability we can target what components of a food are causing a problem and remove those or put in place the interventions to decrease the risk to that particular component of the food lifecycle, in that way we can save lives and reduce illness but also reduce costs to companies who have occasionally been inappropriately targeted when traceback was inadequate, and also when there's a whole industry but it's only one processor or manufacturer is the problem, we can protect the whole industry.
DeGette finished by asking about the exemption from the traceability requirements in the bill for farmers that sell directly to consumers or restaurants. She asked if it was appropriate. Hamburg said: "We have to recognize burdens to small businesses but we have to guarantee we can locate a contained food." DeGette added, "These local farmers markets are not broadly distributing food so if someone did get sick, the local health dept can take care of it."
Shimkus came next. He wants the FDA to test the proficiency of labs, to make sure that the labs used to test food are providing accurate results. She agreed that this was important. Then he brought up the money issue again, asking if he amount of money that the fees in the bill would provide to the FDA were really needed. She said that the fees actually would not cover the cost of the inspections and the FDA needs more money than that.
Next up, Harman. She asked about the FDA's labs and whether they can get results to the FDA in a timely manner. Hamburg replied: "We're eager to implement a system that includes laboratories reporting positive tests to FDA." Harman replied, "Good, I appreciate that too in light of the recent outbreaks, its important to get the information out and accurate as soon as possible."
Christenson spoke next, asking whether the bill gives enough access to the FDA to see companies' records during inspections, or would the FDA benefit from getting access to the records prior to the inspections. Hamburg replied: "We don't want to burden industry, but we do need access to records to inform our routine inspection activities, to work with companies to make sure they have the right safety plans in place, and in the event of a serious outbreak." Christenson followed up, saying, "So you think your ability to have their plans audited should be sufficient?" Hamburg said, "We want this to be a dynamic process as we learn more, putting the policies in place and learning from experience but the bill lays out a sensible and doable approach."
Then Christenson asked about the task of hiring and training inspectors and Hamburg's request for flexibility. She asked if Hamburg wants general flexibility or a specific timetable for inspections. Hamburg replied, "We just need to recognize the enormous scale and we need the time to do it right, so we'd like general flexibility so we can learn as we go in terms of the inspection schedule and some of the requirements."
Christenson's last question was, "What can you say about how the FDA and USDA work together, and about the concerns leading to suggestions to a single food safety agency?" Hamburg replied that her first and most urgent priority is to strengthen food safety within FDA and there are many things we can do there. She said:
Part of doing that is strengthening coordination with partners like the USDA as well as with state and local public health organizations, and with other international agencies and foreign governments because we're going to see the percent of food coming in from overseas increasing in the years to come and the globalization has a profound impact on the work of the FDA.
Next, Sutton spoke, pointing out that Ohio has been hit hard by issues arising from food safety. One of her constituents died of salmonella this year, and another - a 7-year-old girl - died of E. coli. She asked, "What is your opinion about the need for recall authority? This bill gives 2 types of recall authority, giving companies the opportunity to call a voluntary recall before the FDA mandates a recall unless it's truly an emergency."
The voluntary recall is good but you DO need emergency mandatory recall, because there have been cases where recalls have been delayed bc of reluctance of companies to do a voluntary recall, and that puts consumers at risk. Having the mandatory recall as an emergency measure is very, very important. This becomes even more important in a case of bioterrorism. Also, having the mandatory recall as a tool may also make it easier to convince companies to call a voluntary recall.
Sutton asked whether only the FDA commissioner should be able to call for mandatory recalls or subpoenas, or should others at FDA have that authority? Hamburg said that senior level officials should also have those authorities.
Green came next, asking "Does the FDA plan to review the locations of current FDA labs and how does the FDA plan to evaluate the locations of labs?" Hamburg answered: "We don't have any plans to expand the basic network of labs, but with additional resources and expanding need that might be a possibility."
Markey spoke last, asking about BPA. He has bill to ban it but the food and beverage companies launched a PR campaign in favor of it. He asked, "Is the FDA concerned and what do they plan to do?" She replied that the FDA is concerned and that their chief scientist is looking at the issue. She also noted that state and local governments are taking action on BPA and she hopes that the FDA can take leadership on it.