[Congressional Record (Bound Edition), Volume 156 (2010), Part 12]
[Senate]
[Pages 17687-17689]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 THE FDA FOOD SAFETY MODERNIZATION ACT

  Mr. ENZI. Mr. President, the United States has one of the best food 
safety systems in the world. However, even the best of systems have 
room for improvement. That is why my colleagues and I worked together 
over the past year to produce a bill that has broad bipartisan support. 
Food safety is not a partisan issue. We all want the safest food supply 
possible and the Food Safety Modernization Act makes significant 
improvements in that direction.
  This is not a perfect bill. If it were solely up to me, there are 
several provisions that I would have done differently. However, this 
bill provides real improvements for our food system by placing a 
greater emphasis on prevention and targeting government involvement to 
the areas of greatest need.
  The American food industry is made up of hundreds of thousands of 
processors, distributers, and retailers of all sizes, both foreign and 
domestic. When you say ``food industry'' many think of the Nations 
largest food processors that carry the brand names with which we are 
familiar.
  In truth, ``industry'' also consists of tens of thousands of small 
businesses across the country. It also includes over 2 million farmers, 
both large and small, in the United States that provide the food that 
we consume at our tables. This bill recognizes the diversity of all 
these individuals and organizations and protects their ability to 
continue to grow safe food for our families.
  The bill also recognizes the vital role played by State and local 
officials. Our State officials are on the front lines when it comes to 
responding to food safety concerns and this bill makes sure that they 
will have the resources they need to do their jobs. Specifically, the 
bill provides training and education of State, local, and tribal 
authorities to facilitate the implementation of new standards under the 
law.
  My colleagues, including Senators Harkin, Gregg, Durbin, Burr and 
Dodd, have recognized all these challenges in this process and have 
worked together to prepare a bill that makes improvements to all 
aspects of our food system.
  I am particularly pleased with the efforts the group has made in the 
managers' package that focus on providing flexibility for small and 
very small food processors. This bill provides small processors 
additional time to comply with new food safety practices and 
guidelines. The bill also requires the FDA to publish user-friendly 
small

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entity compliance guides to assist firms with the implementation of new 
practices. This way, small businesses in the food system, know exactly 
how to plan to adopt any new practices that could apply to them.
  This bill also protects farms. Farmers remain exempt from 
registration under the Bioterrorism Act and any new produce safety 
standards must consider the unique practices that farmers use to grow 
or market their food. This includes consideration for farmers that use 
specific conservation practices or grow organic foods under the Organic 
Foods Production Act.
  Small entities that produce food for their own consumption or market 
directly to consumers are also not subject to registration under this 
bill. This ensures that individuals can continue to provide food to 
their communities through farmers markets, bake sales, public events 
and organizational fundraisers. Some have confused this bill with 
provisions in other food related bills and it is not true that S. 510 
regulates backyard gardens or potluck dinners. All across Wyoming, 
people grow their own food and contribute dishes to organizational 
fundraisers and this bill continues the practice of making sure those 
individuals aren't subject to federal regulation.
  However, if the amendment tree is filled so amendments cannot be 
submitted, I will likely oppose any further cloture.
  I want to again recognize and thank my colleagues who have worked on 
this bill. I look forward to considering this bill on the floor and 
appreciate those Members that have helped make this bill a bipartisan 
effort.
  Mr. INOUYE. Mr. President, I am pleased that through the leadership 
of the Health, Education, Labor, and Pensions--HELP--Committee, S. 
510--the Food and Drug Administration--FDA--Food Safety Modernization 
Act--Food Safety Act--will be taken up on the floor of the Senate. I 
believe that consideration of the Food Safety Act represents positive 
steps toward better protections for the safety of the American people.
  I am also pleased that a few of the provisions from my Commercial 
Seafood Consumer Protection Act--Seafood Safety Act--that I introduced 
on September 29, 2010, have been incorporated into S. 510. I am, 
however, disappointed that more of the Seafood Safety Act could not be 
included, and will continue to work on passage of the full bill.
  The Seafood Safety Act will strengthen the partnership between the 
Secretary of Commerce, the Secretary of Health and Human Services, HHS, 
the Secretary of the Department of Homeland Security, DHS, the Federal 
Trade Commission, FTC, and other appropriate Federal agencies, to 
coordinate Federal activities for ensuring that commercially 
distributed seafood in the United States meets the food quality and 
safety requirements of Federal law. The bill provides for no new 
jurisdiction and does not alter any existing jurisdiction given to FDA 
or any other agency. The bill does not include any authorization of 
appropriations, but seeks only to strengthen existing partnerships and 
share information.
  The bill remains largely unchanged since I introduced it in the 110th 
Congress, but this version incorporates the FTC as an additional 
partner since they have broad existing authority for consumer and 
inter-state commerce fraud issues.
  Specifically, the bill requires the Secretaries of Commerce, HHS, 
DHS, and the FTC to enter into agreements as necessary to strengthen 
cooperation on seafood safety, seafood labeling, and seafood fraud. 
Those agreements must address seafood testing and inspection; data 
standardization for seafood names; data coordination for the purposes 
of detection and prosecution of violations regarding importation, 
exportation, transportation, sale, harvest, or trade of seafood; 
seafood labeling compliance assurance; and information-sharing for 
observed noncompliance. The bill also increases the number of 
laboratories certified to inspection standards of the FDA and allows 
the Secretary of Commerce to increase the number and capacity of NOAA 
laboratories responsible for seafood safety testing. It allows for an 
increase in the percentage of seafood import shipments tested and 
inspected to improve detection of violations. Finally, the bill allows 
the Secretary of HHS to refuse entry of seafood imports from countries 
with known violations, and also allows the Secretary to permit 
individual seafood shipments from recognized and properly certified 
exporters.
  Again, I am grateful for the leadership shown by the HELP Committee 
and Chairman Harkin on S. 510, yet I remain committed to the Seafood 
Safety Act and look forward to continuing to work to ensure its 
passage.
  Mr. HATCH. Mr. President, I rise today to express my mixed emotions 
on S. 510, the FDA Food Safety Modernization Act.
  With past recalls on spinach, peppers, cookie dough, peanuts and 
peanut products, there appears to be an increase in the frequency of 
foodborne outbreaks. The Centers for Disease Control and Prevention, 
CDC, estimates that foodborne disease cause approximately 76 million 
illnesses in the U.S. each year, including an estimated 325,000 
hospitalizations and 5,000 deaths. These statistics are strong evidence 
that our current food safety laws and regulations are antiquated and 
should be updated.
  We live in a global food economy, but our Nation's current food 
safety laws and regulations are geared predominately to a local and 
domestic market. As a result, there are new safety challenges that have 
risen from this global market that must be addressed.
  As the former chairman and ranking member of the Senate HELP 
Committee--it was then known as the Senate Labor Committee--I have a 
little history on this issue. As chairman of the committee, I 
introduced the Food Safety Amendments with the intent of ensuring a 
safer food supply, similar to the goal of the legislation before the 
Senate today.
  I would like to point out that S. 510 is one of the few bipartisan 
pieces of legislation currently in the Senate. We had Republicans and 
Democrats working across the aisle to come up with solid policies to 
address some of the major gaps in our current food safety system. And 
as we deliberated these policies, it was important to me to protect 
existing laws that already have solid consumer protections. One of 
those laws is the Dietary Supplement Health and Education Act of 1994.
  Briefly, DSHEA clarified the regulatory structure of supplements to 
ensure that individuals would continue to have access to safe 
supplements and information about their use. Under DSHEA, Congress set 
out a legal definition of what could be marketed as a dietary 
supplement.
  We created a safety standard that products have to meet. We allowed 
the FDA to develop good manufacturing process standards for 
supplements. We clarified which claims could be made about these 
products and we said those statements must be truthful and not 
misleading.
  Furthermore, the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act of 2006 created a mandatory adverse event reporting, 
AER, system for dietary supplements and over-the-counter drugs. My 
friend and chairman of the Senate HELP Committee, Tom Harkin, and I 
worked on this law very closely with Senator Mike Enzi, who was 
chairman of the HELP Committee at the time, the late Senator Ted 
Kennedy, who was the ranking member of the HELP Committee at the time, 
and Senator Dick Durbin on this important legislation. Our legislation 
created a system to provide the government with information about 
serious adverse events associated with dietary supplements and over-
the-counter drugs. It provides Federal authorities with a better and 
more effective tool to become aware and to respond to any problems that 
might occur.
  I am grateful and appreciative to the sponsors of the bill for 
including provisions to preserve the DSHEA and AER laws' consumer 
protections as part of S. 510.

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  In addition, I have heard from many of my constituents that they are 
concerned with the international harmonization provisions in this bill 
and its impact on the availability and affordability of dietary 
supplements--in particular, the Codex Commission which is an 
international organization that provides guidelines for food safety. 
Rest assured that the Commission's guidelines on vitamin and mineral 
food supplements will not affect the regulation of dietary supplements 
in the United States unless Congress decides to adopt the provisions.
  Another issue I want to mention is the importance of promoting small 
businesses. Without a doubt, small businesses are the engine for 
economic growth in America and represent a powerful vehicle for 
opportunity. Small businesses contribute greatly to Utah's economy, and 
I am committed to doing all I can to promote job creation, grow our 
economy, and ensure America's businesses are competitive in the global 
marketplace.
  So I am pleased that S. 510 considers the needs of small businesses. 
It accomplishes this by requiring the FDA to publish user-friendly 
guidance to assist firms with the implementation and compliance of new 
practices. It also gives small food facilities additional time to 
comply with the new food safety practices and guidelines. In addition, 
the legislation also requires the FDA to coordinate its outreach 
activities with the National Institute of Food and Agriculture of the 
U.S. Department of Agriculture, USDA, in order to educate and train 
growers and small food facilities about the new requirements from this 
bill.
  Finally, I wanted to address concerns raised by the Utah farming 
community, particularly small farmers. First, this bill preserves the 
current jurisdictional separation between the USDA and the FDA. In 
other words, this bill does not change those who are currently subject 
to USDA regulation versus those who are subject to FDA regulation under 
the existing laws. Second, this bill does not change the existing 
definition of a facility currently required to register with the FDA. 
This means that farms that are currently exempt from registering with 
the FDA under the Bioterrorism Act of 2002 continue to remain exempt. 
Finally, small entities that produce food for their own consumption or 
market directly to consumers or restaurants are not subject to 
registration or the new recordkeeping requirements under this bill. 
This includes food sold through farmers' markets, personal or backyard 
gardens, bake sales, public events and organizational fundraisers.
  Unfortunately with all those great provisions that I just mentioned, 
there is still one major concern that I cannot overlook, the cost of 
the bill. The Congressional Budget Office, CBO, has estimated that the 
legislation will cost $1.4 billion over 5 years. We need to rein in the 
out-of-control government spending, especially in today's fiscal 
environment. We simply cannot continue to drive up the national debt. 
We cannot sustain trillion-dollar deficits. More government spending 
will push the Nation over a precipice from which we may not be able to 
recover.
  Even though this spending is discretionary, it troubles me that if 
future appropriations are not sufficient to cover the cost of the bill, 
Congress would be unintentionally giving the FDA an unfunded mandate. 
If this happens, the FDA would either simply not be able to live up to 
its new responsibilities or would be forced to shift funds from other 
important and already strapped agency programs like the regulation of 
prescription drugs, medical devices, and/or biologics. The latter could 
cause significant harm to the American public. So it is with deep 
regret that I cannot support S. 510 without it being paid for. However, 
I am committed to working with my Senate colleagues to find ways to 
offset the cost of the bill.
  The ACTING PRESIDENT pro tempore. The Senator from Texas is 
recognized.

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