Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in opposition to the bill we are considering under suspension of the rules, S. 2322, the Codifying Useful Regulatory Definitions Act, or the CURD Act. This bill has not proceeded through regular order and codifies into the Federal Food, Drug, and Cosmetic Act a highly prescriptive definition of ``natural cheese'' that should be determined by the FDA, not by Congress. This legislation creates a statutory definition for a specific category of cheese and expressly distinguishes what shall be considered natural cheese from the other standards of identity for processed cheese currently defined in regulation. The bill then codifies these regulatory standards of identity into the statute and expressly preempts any non-Federal definition of the term ``natural cheese.'' The FDA has the authority to define this term, yet proponents of this legislation prefer legislative expediency over sound regulatory decisionmaking. Supporters insist that this definition is needed in statute immediately to assure it quickly applies. However, instead of waiting to proceed through regular order or following the regulatory process, stakeholders are asking for an immediate statutory change because of ongoing litigation that this bill will help to resolve for some stakeholders. Mr. Speaker, I am concerned that by rushing this legislation through we have not been given adequate time to consider the implications for this change or how this definition might impact consumers and other industry stakeholders. The FDA is best positioned to consider the public health impacts of defining this term and how it would interact with other agency efforts regarding nutrition labeling, such as a broader definition for the term ``natural.'' Additionally, I am concerned by the precedent this legislation creates and believe that passing this bill only encourages stakeholders to seek additional statutory changes or definitional clarity for the products when they believe the FDA has not acted as expeditiously as they wish or when they are facing litigation. We should be making changes to the Federal statute when they are necessary and in order to protect the public health, not when industry is seeking a favorable outcome that could be achieved through regulatory process. I do not believe this change is warranted in this circumstance. Finally, Mr. Speaker, I strongly believe that legislation like the CURD Act should be considered through regular order, and I am opposed to this bill, given that the House of Representatives has held no hearings on this issue and has not marked up the bill under consideration today. The Senate passed this bill in the dead of night, with no discussion or debate on the floor. I believe we are abdicating our duty to fully consider the implications of this statutory change if we pass this bill today. On the substance, Mr. Speaker, the Center for Science in the Public Interest, Consumer Reports, and The Good Food Institute are all opposed to this legislation and have raised serious concerns about the impact of this change on consumer confusion and transparency. I include in the Record letters in opposition to the bill from all three. Center for Science in the Public Interest, Washington, DC, December 19, 2018. Dear Member: The Center for Science in the Public Interest writes to urge you to oppose the CURD Act (H.R. 4828, S. 2322). This misguided bill would define ``natural cheese'' in a way that actually muddles, rather than clarifies, the term. For example, it would allow the use of artificial colors and additives in ``natural cheese'' and would also make labeling for cheese inconsistent with U.S. Department of Agriculture (USDA) labeling requirements and possibly also with the Food and Drug Administration's (FDA's) labeling requirements for other ``natural'' foods. The bill could also prevent the term ``natural'' from being used on non-dairy cheese alternatives that may otherwise rightly be considered natural by consumers. The stated purpose of the bill is to draw a clear line for consumers between ``natural cheese'' and processed cheese. Yet we have seen no evidence that consumers are confusing processed cheese with natural cheese in the marketplace. The FDA's current standards of identity for processed cheese types already require that these cheeses include a specific statement of identity on the label indicating that they are ``process cheese.'' And there are currently strong incentives for the manufacturers of process cheese to avoid ``natural'' claims, as this could expose cheesemakers to liability. Rather than protecting consumers, the bill would confuse them by permitting misleading ``natural'' claims on products that most Americans would not consider natural. For example, a nationally representative telephone survey conducted in May 2018 by Consumer Reports found that more than 80 percent of consumers say ``natural'' should mean no artificial ingredients were used. Yet the CURD Act allows for the use of synthetic food dye, artificial flavors, and other artificial additives in so-called ``natural cheese.'' Similarly, an overwhelming majority of Americans surveyed felt that use of the term ``natural'' should be reserved for foods that deploy natural agricultural practices to produce the food's ingredients, including by limiting the use of hormones, pesticides, and antibiotics. In contrast, the bill would allow the term ``natural cheese'' to appear irrespective of the agricultural practices used to produce the cheese's ingredients. The bill would also make labeling for ``natural cheese'' inconsistent with USDA and with likely future FDA requirements for ``natural'' on food labels in general. The USDA currently permits the use of the term ``natural'' on products that contain no artificial ingredient or added color and which are only minimally processed. In addition, understanding that ``natural'' can have many meanings, the USDA requires a brief statement of meaning on labels to avoid confusion, stating, that the food is ``*no more than minimally processed and contains no artificial ingredients.'' The FDA is also currently considering adopting a definition of ``natural'' and may create similar requirements based on comments in its public docket on the issue. Yet the bill would authorize the claim ``natural cheese'' to be used on cheese in a manner that fails to align with either the USDA's current rules or prospective FDA requirements, leading to inconsistency and confusion across the marketplace. Finally, the bill defines ``natural cheese'' in a manner that could be interpreted to prohibit use of the term on non- dairy alternatives intended for consumers who are vegan, lactose intolerant, or who otherwise wish to avoid dairy cheeses. Use of the term ``natural'' should not be prohibited on these products, provided the products otherwise meet consumer expectations for use of this term. The FDA is currently working on a definition of ``natural'' that would be non-misleading, based on consumer understanding, and apply uniformly to all FDA-regulated foods, including cheese. Congress should not act prematurely to carve out a definition for ``natural cheese'' before the agency has taken action to define ``natural'' for other products. For these reasons, we urge you to vote ``no'' on the CURD Act. Sincerely, Sarah Sorscher, Deputy Director of Regulatory Affairs, Center for Science in the Public Interest.

Mr. PALLONE. Mr. Speaker, we should not displace the important role of the FDA in determining the correct terminology and approach to regulating and labeling food products like cheese. Changes to the statute should be considered in broad daylight, with robust discussion and significant input from consumer, industry, and government stakeholders. That has not happened in this case, and for these reasons I oppose the bill and urge my colleagues to oppose the bill as well. Mr. Speaker, I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I rise to recognize the longtime service of Michelle Ash to the House of the Representatives. Michelle is leaving Congress after 25 years of distinguished service. For 25 years this institution has greatly benefited from Michelle's passion for protecting consumers. Over the last decade, as the Energy and Commerce Committee's Chief Counsel for Consumer Protection, Michelle has been at the helm for many policy issues that directly impact consumers. Whether it be developing the guidelines for ensuring that autonomous vehicles are safe, keeping unsafe toys off the shelves, ensuring safe packing of toxic substances, fighting to protect Americans' personal data from abuse and misuse, or protecting consumers from scams, Michelle always puts consumers first. A native of Pittsburgh, Pennsylvania, Michelle decided soon after graduating from law school that a career in a law firm was not where she saw herself making a difference. Instead, she wanted to be involved in crafting policy, and there was no better place to do that than here in Washington. Michelle began her career in the House in the office of then- Congressman Ben Cardin of Maryland. There she focused on foreign affairs, the judiciary, Social Security, and congressional ethics. In 1997, she served for a short time as counsel for the House Ethics Reform Task Force. In 1998, she joined the staff of the Oversight and Government Reform Committee as Chief Legislative Counsel for then Ranking Member Henry Waxman. At OGR Michelle focused on legislative initiatives that brought more transparency to government, including initiatives to protect whistleblowers. Ten years later, in 2009, when Congressman Waxman became Chairman of the Energy and Commerce Committee, Michelle moved over with him to serve as the Committee's Chief Counsel on Consumer Protection. Over the last ten years, Michelle has been a determined consumer advocate, pressing federal agencies to put safety first by using all the tools and authorities at their disposal to protect consumers and holding companies accountable when their actions harm consumers. She has pushed the Consumer Product Safety Commission to take swift action to protect Americans, and particularly children, from furniture tip- overs, dangerously strong magnets that were being swallowed by kids, liquid nicotine improperly packed and being ingested by kids, and much more. She has continuously fought to give the Federal Trade Commission more authority to fulfill its mission to prevent harm to consumers, not just taking enforcement action after harm has already been done. She has also worked to advance the cause of auto safety--urging more effective and expedient action on deadly unintended acceleration and brake failures, faulty ignition switches that prevented airbags from deploying, and exploding airbags that turned a safety device into a death device. And at the same time, she has been a mentor to many young staffers, sharing with them the benefits of her experience and expertise. Having spent 25 years working on Capitol Hill, there have been many late nights and weekends spent negotiating legislative language and preparing for committee hearings, and I want to acknowledge the support Michelle has received from her husband, Doug Klein, and children, Erin and Sasha. Mr. Speaker, American consumers are safer today thanks to Michelle Ash's 25 years in Congress. I wish her nothing but the best in her future endeavors.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, today I rise as the ranking member of the House Committee on Energy and Commerce to appoint Timothy R. Robinson to the National Security Commission on Artificial Intelligence temporarily. I am taking this action today to preserve my appointment authority to name a member to this commission. Upon conducting a thorough review of suitable candidates for appointment, it is my intention to submit the name of another individual, who will replace Mr. Robinson. My authority to effectuate this appointment or any future replacement appointment is set forth in section 1051 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I want to state my concerns regarding H.R. 6886 and the process for considering this bill, and the potential unintended consequences for the Medicare program. The bill seeks to address the unfortunate circumstances under which a servicemember who becomes eligible for Medicare by reason of disability cannot easily return to the TRICARE program if and when the servicemember becomes able to work again. I am concerned because this bill did not go through regular order, and was not marked up or considered in any committee of the House of Representatives. It represents a significant change to current law and has impacts on both our healthcare system for active and retired service members, and on the Medicare program. To pass such legislation without an open, transparent, and measured process is disservice to the institution of the House of Representatives and to the American people. The problem with a failure to adhere to regular order is not just a philosophical one but a practical one. Legislation that has not been vetted properly often has unforeseen or unexpected consequences. We have seen that time and time again. I am concerned that this will also be the case with H.R. 6886. I am concerned about disabled servicemembers moving in and out of the Medicare program, and whether they will be fulling informed about the implications of their decision not to enroll in Medicare when they become eligible. I am concerned about the precedent for the Medicare program of folks being able to decline Medicare coverage for other coverage, and how that may undermine the universality of the Medicare program. I might have been able to be convinced that these concerns could be addressed if we had had a full process with a legislative hearing and a markup, but unfortunately, that is not the case. For these reasons, I must state my concerns regarding this bill and the process we undertook for considering it.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 6, the SUPPORT for Patients and Communities Act. This bill is the product of many months of hard work by several committees in the House and Senate. It is important that we pass this bill today as another step in addressing the opioid crisis that is ravaging every community in our Nation. Last year, a record 72,000 Americans died of drug overdoses; that is about 200 people dying every day, and this is a national crisis that is devastating families and that this Congress must act on. And while this legislation will not solve every problem, I do believe it includes important policies that will help turn the tide of this tragic opioid epidemic. It will also improve treatment options for those battling other substance-use disorders. I am proud that H.R. 6 builds upon CARA, the Comprehensive Addiction and Recovery Act, by including a provision championed by my colleague, Congressman Tonko, that would allow all advanced practice registered nurses to treat patients with bupe for opioid-use disorder. It also gives nurse practitioners and physician assistants the authority to treat patients with bupe permanently, and it codifies the 275 patient physician cap. This is a critical step in expanding access to the treatment of these drugs, one of the major challenges that we continue to face in the fight against this epidemic. Mr. Speaker, the legislation also expands access to coverage. It includes an important provision that I worked on with Ways and Means Committee Ranking Member Neal that expands Medicare coverage of opioid treatment programs and medication-assisted treatment. In the Medicaid space, I am pleased to see the inclusion of several Democratic priorities. This bill requires State Medicaid programs to cover all forms of medication-assisted treatment, which plays a critical and lifesaving role in treating opioid use disorder. It provides grants to State Medicaid programs to help increase the number of substance use disorder providers and services. It increases access to mental health and substance use disorder treatment for children and pregnant women covered by CHIP, and it ensures former foster youth are able to keep their Medicaid coverage across State lines up to the age of 26. And it improves the continuity of Medicaid coverage for juveniles in the justice system. I am also pleased that we have been able to improve upon the House- passed IMD policy. This bill adds new safeguards to ensure that States continue to provide an adequate level of outpatient services and offer medication-assisted treatment. It does this by making clear that this policy does not impact the more comprehensive efforts to provide care in IMDs that is ongoing in many States today. H.R. 6 also includes provisions from my legislation, the SCREEN Act, that would give the Food and Drug Administration the ability to take action against illicit controlled substances coming in through international mail facilities across the country. FDA will now be able to prohibit the importation of drugs by people who have repeatedly imported illicit drugs. It also allows the agency to cease distribution of or recall controlled substances, like opioids, if they are endangering patients. These provisions also provide FDA expanded authority and capacity needed to more effectively combat the influx of deadly synthetic opioids, like fentanyl, from reaching our shores through the mail in the first place. It also provides the Federal Trade Commission with stronger enforcement tools to go after bad actors that are taking advantage of the suffering of individuals combating addictions. Mr. Speaker, there is one provision that is concerning and that I do want to mention. It did not go through regular order and was not properly vetted. In fact, it was added at the very last minute. That is a proposal by Senator Rubio to create a new criminal antikickback statute. I know this proposal is well-intentioned in addressing the serious problem of patient brokers who are taking advantage of individuals with opioid use disorders and referring them to substandard or fraudulent providers in exchange for kickbacks. This is an issue, but since the bill was introduced last Tuesday night, multiple stakeholders have raised concerns that the language does not do what we think it does. It may have unintended consequences. Mr. Speaker, I hope this is a good lesson to all of us that passing legislation that has not been properly vetted, and that the public has not had an adequate chance to review, is unwise. I hope to get a commitment from Chairman Walden and Chairman Goodlatte to work to address any technical problems with this provision in the upcoming months. In closing, Mr. Speaker, these are all policies that have the potential to make a real impact on this epidemic, but our work here is not complete. An epidemic of this size will take a long-term commitment to improving health insurance coverage, treatment, access, and affordability. This bill is an important step, but I want to stress that we have to do a lot more. The opioid crisis continues to get worse. A lot more needs to be done to provide treatment and expand the treatment infrastructure. More resources are needed to support the families and communities impacted by this crisis. So what we are doing today is clearly helpful, but it is not enough. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from Massachusetts (Mr. Neal), the ranking member of the Ways and Means Committee who worked so hard on this legislation as well.

Mr. PALLONE. Mr. Speaker, I yield 4 minutes the gentleman from Maryland (Mr. Cummings), the ranking member of the Oversight and Government Reform Committee.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from New York (Mr. Tonko), a member of the committee.

Mr. PALLONE. Mr. Speaker, I yield an additional 30 seconds to the gentleman from New York.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from Michigan (Mrs. Dingell), also a member of the committee.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr. Gene Green), the ranking member of our Health Subcommittee.

Mr. PALLONE. Mr. Speaker, may I inquire as to how much time remains on each side.

Mr. PALLONE. Mr. Speaker, I yield 1 minute to the gentleman from New Mexico (Mr. Ben Ray Lujan).

Mr. PALLONE. Mr. Speaker, I yield myself 1 minute. Mr. Speaker, before we conclude debate, let me just take a moment to thank everyone for all of their hard work getting this bill across the finish line. This bill represents a collection of Member ideas and policies across the political spectrum. Many people may not know this, but the staff of the House and Senate committees negotiated this bill in a matter of weeks, and that is no small feat. It took a lot of effort, long hours and weekend work to pull this off. It is a product we can all be proud of. So let me thank all legislative counsel and CBO for their efforts as well. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my time.