Today, the House Appropriations Subcommittee on Agriculture heard budget related testimony from the Food and Drug Administration.
Committee Chairman Hal Rogers (R., Ky.) noted at today’s hearing that, “Like many, I am concerned about obstacles created by the Chinese government to our inspection of foreign food and drug products. While the safety of American consumers is our paramount concern, there is also a fundamental question about fair trade practices. Domestic manufacturers and producers are subjected to extensive regulation to ensure the safety of their products, and they should have an equal playing field with their foreign competitors. The Fiscal Year 2015 Omnibus included $2 million to speed up drug facility reviews in China, and we are looking forward to an update on this effort.”
In his opening statement, Subcommittee Chairman Robert Aderholt (R., Ala.) indicated that, “The size of FDA’s FY 2016 request includes increases for budget authority that disregard the debt crisis facing our nation. The agency is proposing large increases using scarce discretionary resources. Since FDA is informing Congress that Food Safety, Medical Product Safety, and Rent and Infrastructure needs are their highest priorities this year, it will be incumbent upon FDA to prove to Congress that such priorities cannot be funded out of base resources first.”
Subcommittee Chairman Aderholt added that, “FDA’s request for budget authority exceeds the 2015 enacted funding level by six percent.”
FDA Commissioner Dr. Margaret Hamburg, who is stepping down at the end of the month after six years in that position, noted the FDA’s work on the Food Safety Modernization Act and stated at the hearing: “FDA published seven major proposed rules and, based on stakeholder input, four supplemental proposals to implement FSMA. The Agency also completed 8,607 high-risk food establishment inspections in FY 2014, exceeding the target of 6,507 inspections by 32 percent. FDA also released a FSMA Operational Strategy Document that focuses on how we can implement FSMA by prioritizing prevention, voluntary compliance, risk-based oversight, and expanded collaboration across the food safety community.”
During the discussion portion of the hearing, Subcommittee Chairman Aderholt focused on the 2015 Dietary Guidelines Advisory Committee Report, which was released last month.
Below is a transcript of the discussion on this issue.
Rep. Robert Aderholt: Let me switch over to dietary guidelines. The Department of Health & Human Services, and of course FDA is a part of that, has a lead role in developing the dietary guidelines for Americans in 2015. The Secretary of Agriculture appeared before this subcommittee, was sitting where you are sitting just about a week ago. He made a commitment to adhere to the statutory directive for developing the dietary guidelines for Americans. And as he put it, and this was his quote, “I know my role and I will color within the lines.”
I reminded him, when he was here last week, of the need to stay focused only on the dietary and nutritional recommendations of the Dietary Guideline Advisory Committee and subsequent comments collected by USDA and the Department of Health & Human Safety about these recommendations. To quote from former Senator Bob Dole, he said, “I believe the committee exceeded its mandate when it made dietary recommendations based on environmental concerns of sustainability.” I urged the Secretary of Agriculture and the Secretary of Health & Human Services to [amend] those recommendations in issuing their final guidelines.
The science of nutrition can be confusing to the average consumer. Integrating environmental considerations into dietary recommendations lessens the report’s impact and usefulness. My question, Commissioner, would be, as a vital player in the development of these final guidelines, can we get an assurance from the Department of Health & Human Services that the final report would include only nutrient and dietary recommendations and not include environmental factors and other extraneous material?
Dr. Margaret Hamburg: Well, our role in the nutrition space is a little bit different. We are involved, of course, in the dietary guidelines, but that’s not our direct responsibility. We have many responsibilities directly in areas of nutrition and nutrition science. And I’m really happy to be able to report to you that we have a very strong commitment to science-based decision-making in our nutrition programs, that as we look at what matters to promoting health and protecting health of the American public with respect to health and nutrition, you know, we spend a lot of time examining what is known, what does the [literature] show, soliciting input from other experts in helping to get additional information that we might not be aware of. We also do undertake research ourselves and in partnership with others.
We also have just recruited a wonderful new director of our Center for Food Safety & Applied Nutrition, Dr. Susan Mayne, who is here, who we got from Yale University, you know, who has a long and distinguished career in nutrition science and health. So I think we are well positioned to help advance understanding and to make sound policies based on evidence. And certainly we try very hard to color within the lines, too. We already have responsibilities that outstrip our resources. We have no desire to take on new activities that are outside of what we’ve been mandated and asked to do.
Rep. Aderholt: Okay, I’ll take that as a yes then, so… I find it interesting that the advisory committee has found that cholesterol is not an nutrient of concern for over consumption, even though previous dietary guidelines have recommended limiting cholesterol intake to [no] more than 300 milligrams per day. There are other such examples in the recent past where the advisory committee completely changed its focus, despite claims of sound science.
The advisory committee also recommended a diet higher in plant-based foods and lower in animal-based foods as more health promoting, even though lean meat has been included as a part of a healthy, balanced diet in previous dietary guidelines. How are consumers supposed to feel confident about following the dietary guidelines when the recommendations contradict what was just put out five years ago?
Dr. Hamburg: Well, I think one of the challenges in this arena and other arenas as well is that the science base is always changing. Also, with the vast array of different kinds of studies going on, with different perspectives, it can get very confusing about emerging [science] and how to put it into context, and what information consumers should rely on.
Again, I come back to my earlier answer that we really view as the foundation of the work we do establishing the database and the evidence for regulatory decision-making, but recognize that this is a dynamic process, and new evidence emerges as understandings of the science and of human biology advance, and as that happens, we do think it’s very important to periodically update the work we’re doing.
For example, not too long ago we put forward a proposal to update our nutrition facts label, which is the nutrition information on the back of various kinds of processed and other foods. That was first begun, I think now, more than 20 years ago. And some of the nutritional components being represented there didn’t represent advances in nutrition science, and also the serving size information didn’t reflect current practices and behaviors of American consumers. So I think that’s very important so that Americans can have access to the most recent and updated information so they can make informed choices.
Rep. Aderholt: I reminded Secretary Vilsack, when he was here last week, of the enormous impact the dietary guidelines have on individual diets. Also nutritionists and dieticians who plan and prepare food for schools and other institutions and elsewhere across the United States. I suggested to him that the 45 day timeline for the comments is too short. And he committed to discussing extending that comment period for an additional 60 days with Secretary Burwell. Can I get a commitment from you that you and your colleagues will convey that need to extend that comment period?
Dr. Hamburg: Well, I will certainly reflect back to Secretary Burwell, you know, your comments in this discussion.
Rep. Aderholt: Thank you. Well, as I say, he was…the Secretary, I think, he was in agreement that this additional 60 days was important because of the impact of this, and so we would appreciate your conveying that to the Secretary, and that how…that this, we…many of us feel here on the committee that it is important as well.