Date: 2015-02-05
Speaker: JACKSON LEE (democrat)
Chamber: H

Mr. Chairman. let me thank the chairman. thank the mover of this legislation. my ranking member. Mr. JOHNSON. and my ranking member of the full committee. Mr. CONYERS. for their leadership and for bringing us together around a universal concept. We all are promoting jobs. Mr. Chairman. Not one of us on this floor wants to in any way undermine jobs. We want people to work. and we want small businesses to have the opportunity to thrive. What I am talking about is the reality of protecting the American people when it comes to unique issues of health care. I am not going to cite the name of this individual. but what I am going to do is to read just a paragraph from Al Kamen. Kamen. "In the Loop": "As a matter of fact. I think this is one where I think I can illustrate the point." he recalled telling her. "I dont have any problem with Starbucks if they choose to opt out of this policy as long as they post a sign that says. We dont require our employees to wash their hands after leaving the restroom. The market will take care of this. It is one example." Now. I have a different perspective. and so my amendment under this legislation asks to make an exception for rules that are dealing with consumer safety. saving lives. My amendment makes an exception for rules from the Food and Drug Administration. commonly known as the FDA. This bill. H.R. 527. seeks to reform the Regulatory Flexibility Act of 1980 and 1996 which attempted to require agencies to account better for the impact of proposed regulations on small businesses. other small entities. and to tailor final regulations to minimize adverse impacts on these entities like the Food and Drug Administration. Yes. small business can be a single franchise of a McDonalds or Burger King or Starbucks. many of them doing quite well. It could be a number of them under one businessowner. But. in fact. they do deal with the public. This bill continues to expand the reach and scope of the Regulatory Flexibility Act and would only add to already unnecessary and lengthy regulatory delays. increased meddling by regulated industries. and encourage gratuitous court challenges. The Small Business Regulatory Flexibility Act adds a host of new analytical requirements for agency policy actions. including rulemakings and guidance documents. that might affect a large number of small businesses. even if that is indirect. Because the bill defines indirect effects broadly. it would mandate costly and wasteful new analyses that could be applied to virtually any action and agency attempt to make a better life for Americans. no matter how tenuous the connection to business interests. Again. can we imagine not being able to regulate or interfere with some small business that says you do not have to wash your hands in a restaurant? It is shocking to me. Mr. Chairman. when I wrote this amendment. I had in mind one of the new issues that we have been facing. and that is the story of CRE. which is a disease that is being found on endoscopes. that has been found in a particular hospital in the far West. This disease. this rare bacteria. was likely spread through specialized endoscopes that have been cleaned according to manufacturers directions but still had some form of deadly germs. Are we suggesting that it is not an emergency to regulate or to keep or to be able to suggest that there needs to be a better cleaning process? This is just the latest example of a life -threatening disease which is calling out for action from the government. and the CDC and the FDA should not have their hands tied. In fact. the Houston Chronicle reported last week that these problems of dirty endoscopes have been tied to superbug infections in cities like Chicago and Pittsburgh in recent years. Although the bacteria werent exactly the same. the situation raises new questions about the design. this infection. and regulation of the devices. Mr. Chairman. let me tell you that our economy is doing fine. not for every single American. but it has a marked improvement. Jobs are increasing. and unemployment is under 5 percent. I would only say that this legislation needs an addition from this amendment. and I hope my colleagues will accept the Jackson Lee amendment. It is a commonsense amendment that speaks to the health and care of the American public. Mr. Chairman. I ask for support of the Jackson Lee amendment. Mr. Chair. thank you for this opportunity to briefly explain my amendment. My amendment makes an exception for rules from the Food and Drug Administration. commonly known as the FDA. This bill. H.R. 527. seek to reform the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996. which attempted to require agencies to account better for the impacts of proposed regulations on small businesses and other small entities and to tailor final regulations to minimize adverse impacts on these entities like the Food and Drug Administration. In reality. the Small Business Regulatory Flexibility Act expands the reach and scope of the Regulatory Flexibility Act and would only add to already unnecessary and lengthy regulatory delays. increase meddling by regulated industries. and encourage gratuitous court challenges. The Small Business Regulatory Flexibility Act adds a host of new analytical requirements for agency policy actionsincluding rulemakings and guidance documentsthat might affect a large number of small businesses. even if that effect is "indirect." And because the bill defines "indirect effects" broadly. it would mandate costly and wasteful new analyses that could be applied to virtually any action an agency attempts to undertake. no matter how tenuous the connection to small business interests. And according to the American Sustainable Business Council. this bill would open the door for regulated industries to manipulate the regulatory process in their favor. This undue influence would paralyze the regulatory process. creating uncertainty in the marketplace and stifling competition and innovation from small- and mediumsized entities. When I wrote this amendment I had in mind the rare bacteria like that known as carbapenemresistant Enterobacteriaceae. commonly known as CRE. This rare bacteria is being transmitted to patients even though the tools had been cleaned according to manufacturers directions but still harbored the potentially deadly germs. This is just the latest example of a lifethreatening disease which is calling out for action from the governmentand the CDC and the FDA should not have their hands tied. The Houston Chronicle reported in a story last week: The Seattle outbreak appears to be among the worst so far in the U.S.. where problems with dirty endoscopes have been tied to superbug infections in Chicago and Pittsburgh in recent years. Although the bacteria werent exactly the same. the situation raises new questions about the design. disinfection and REGULATION of the devices. critics charge. The bill reforms the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996. which attempted to require agencies to account better for the impacts of proposed regulations on small businesses and other small entities and to tailor final regulations to minimize adverse impacts on these entities like the Food and Drug Administration. Mr. Chair. the economy is doing fine now. not for every single American but it has seen a marked improvement from 2008. A bill like H.R. 527 only serves to gumup the wheels of government and business collaboration by creating new and confusing rules. When added to the existing gauntlet of procedural and analytical requirements that agencies must already navigate in order implement laws. SBRFIAs new requirements would serve only to further "ossify" rulemaking and make it nearly impossible for agencies to fulfill their congressionally mandated mission of protecting the public and responding to emerging health and environmental dangers. The Small Business Regulatory Flexibility Improvements Act also ties the hands of agencies like the FDA by forcing them to delay actions until new analyses are completed. Under current law. an agency can continue to promulgate a regulation before it has finished the regulatory flexibility analysis. if the agency head believes its mission or the law calls for more immediate action.