Combating Foodborne Illness: The Food Safety Modernization Act

Reading time: 6 – 9 minutes

Approximately one in four Americans get sick by foodborne illness each year [1]. Of those 76 million people, an estimated 325,000 are hopitalized and 5,000 die. Indeed, foodborne disease outbreaks reported to the CDC alone through the Foodborne Disease Outbreak Survelliance System recorded 1,247 outbreaks in 2006 [2].


The vast majority of known foodborne illnesses are associated with products regulated by the U.S. Food and Drug Administration (FDA). According to Jeff Levi, Ph.D., Executive Director of Trust for America’s Health, a non-profit, non-partisan organization working to make disease prevention a national priority [3]:

Our food safety system is plagued with problems, and it’s leading to millions of Americans becoming needlessly sick each year. The system is outdated and unable to effectively deal with today’s threats. Its current structure actually prevents the kind of coordinated, focused effort that Americans need more than ever and have a right to expect.

Supported by a grant from the Robert Wood Johnson Foundation, Trust for America’s Health recently released a report entitled Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, which examines the problems with the U.S. Food Safety System [4]. The report identifies a number of problems with the current system, including:

  • Outdated laws and policies that are focused on monitoring the end of production instead of trying to detect and prevent problems along the entire production process.
  • Insufficient statutory authority to develop an integrated risk minimization strategy.
  • Lack of modernization with food safety policies largely based on early 20th-century laws.
  • Limited legal tools for FDA enforcment of food safety standards.
  • No centralized authority that has oversight and accountability.
  • Chronic underfunding and understaffing.
  • Limited federal, state and local coordination.

The report calls for the immediate consolidation of food safety leadership within the FDA under one top administrator and the creation of a separate Food Safety Administration within the Department of Health and Human Services.

The Food Safety Modernization Act of 2009

A legislative proposal to remake the U.S. food safety system is currently being deliberated and investigated by a committee in the U.S. House of Representatives. Representative Rosa DeLauro is sponsor of H.R. 875, the Food Safety Modernization Act, which seeks to establish the Food Safety Administration (FSA) within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring food safety, improving research on contaminants leading to food safety, and improving security of food from intentional contamination [5].

While there are many postitive aspects of the bill, such as the adpotion and implementation of a national system for the registration of food establishments (i.e. improved ability to trace the food supply) and the establishment of science-based standards for (i) potentially hazardous substances that may contaminate food and (ii) safety and sanitation in the processing and handling of food, H.R. 875 represents a significant expansion of federal regulation. The FSA would set safety regulations for food establishments and food production facilities.

And therein lies the the problem with this bill: the definitions are so broad that essentially anyone growing food could be regulated. For example, the bill defines five categories of food establishment, one of which “means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).” In addition, a food production facilty is defined as “any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.”

   Talk about broad definitions that make no exclusions of any kind!

Internet hysteria aside, it’s tenable that small farms would be negatively impacted by this regulation. According to Food & Water Watch, a nonprofit consumer organization that works to ensure clean water and safe food in the U.S. and around the world, the issues include [6]:

  • Extension of electronic recordkeeping requirements to farms and restaurants.
  • Provision for food production facilities to pay a registration feed to fund the FDA’s inspection efforts.
  • Establishment of fruit and vegetable production standards and Good Agricultural Practices for produce.

These provisions would likely place a disproportionate financial burden on small farmers, making it more difficult to maintain a farm or generate a profit.

One way to avoid large-scale food contamination and widespread foodborne illness is to decentralize food production and distribution. However, the way this bill is written, the burden of regulation would effectively shut down small food producers; the end result would be the consolidation rather than the decentralization of food producers.

Another way to ensure the safety of food is to regulate food production by way of inspection. However, this method is designed to prevent food contamination altogether, not to minimize the number of infected individuals when contamination does occur. And no system, regardless of how well it is designed, will be infallible. Inspection should be one of multiple layers of security implemented by the U.S. food safety system.

Thus, while the intention of the Food Safety Modernization Act may be to fix the U.S. food safety system, it is written with definitions that are too broadly defined, leaving loopholes open for misinterpreation of the law. Further, any approach to prevent food-borne illness should encourage decentralization of food production and promote small farming, while at the same time developing an electronic tracking system to enable fast and accurate tracing of primary food supply channels. This is a formidable task given the size of the food production industry in the United States.

There are companion bills in both the U.S. House (H.R. 1332, the Safe Food Enforcement, Assessment, Standards, and Targeting Act of 2009) and Senate (S. 510, the FDA Food Safety Modernization Act of 2009), which expand FDA authority. Given the recent foodborne illness outbreaks, it’s forseeable that one of these bills is going to pass this year. Many industry groups are supporting the two bills, likely in an attempt to “avoid the structural overhall that H.R. 875 seeks to implement” [7]. Nevertheless, you should email your congressional members and ask them to oppose this poorly written piece of legislation.


  1. Mead et al. Food-related illness and death in the United States. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25.
    View abstract
  2. 2006 Annual Listing of Foodborne Disease Outbreaks, United States. OutbreakNet Team, Centers for Disease Control and Prevention. Accessed 2009 Mar 30.
  3. New Report Calls Food Safety System Antiquated, Calls for Reform. Trust for America’s Health press release. 2009 Mar 25.
  4. Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services. Trust for America’s Health. 2009 Mar.
  5. H.R. 875: Food Safety Modernization Act of 2009. Accessed 2009 Mar 31.
  6. Background on H.R. 875. Food & Water Watch. Accessed 2009 Mar 31.
  7. H.R.875 – Food Safety Modernization Act of 2009. Accessed 2009 Mar 31.
About the Author

Walter Jessen is a senior writer for Highlight HEALTH Media.


  1. There is obfuscating language in this bill designed to confuse and redirect your attention to thinking by implication rather than specification. This is cleverly illustrated using the words “include(s)”, “exclude(s)” and custom definitions. So let’s take a look at an example.

    (a) In General- Any food establishment or foreign food establishment engaged in manufacturing, processing, packing, or holding food for consumption in the United States shall register annually with the Administrator.

    Notice that annual registration is limited to a Food Establishment or foreign food establishment. One cannot imply that this extends beyond these two entities as defined in the definitions section and only those that engage in manufacturing, processing, packing or holding food for consumption.

    Before I get to what is a Food Establishment or foreign food establishment, let me give you an example of the use of include and typical efforts employed to muddy the waters.

    To start with we must recognize that if a word is meant to be understood as having its common meaning, there is no need to define it at all. It is axiomatic that if a word is explicitly defined, it has a restricted meaning. If language such as the term “Fruit” is used and defined as “includes, apples, oranges, and pears”, it can only be understood as restricting the definition to those things listed, or no definition would be required; the word “fruit” would be understood to include apples, oranges and pears, as well as all other fruits. If the word “common” is left out of the definition, then the things used in the definition are what establish the class to which belong, and as the word is being deliberately defined, the common meaning of the word must be excluded.

    Under the definitions section:


    (A) IN GENERAL- The term ‘food establishment’ means a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.

    (B) EXCLUSIONS- For the purposes of registration, the term ‘food establishment’ does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).

    (14) FOOD PRODUCTION FACILITY- The term ‘food production facility’ means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.

    So a Food Establishment is not a farm, ranch, orchard, vineyard, aquaculture facility, confined animal-feeding operation. This is a custom definition, is specific and no other implications can be drawn as meaning something else. Note that farm, ranch …. since not custom defined, have a common definition without exclusion or inclusion. I do not have cites to their common definition.

    In addition to the above, a Food Establishment is not a restaurant, retail food establishment, nonprofit food establishment or fishing vessel (as limited in definition to section 123.3 of title 21 of CFR). Again, restaurant, retail food establishment …. have a common definition without exclusion or inclusion.

    There is a specific class of actions as custom defined by ‘Process’, all of them being Commercial.

    (19) PROCESS- The term ‘process’ or ‘processing’ means the commercial slaughter, packing, preparation, or manufacture of food.

    Note this means Commercial slaughter, commercial packing, commercial preparation, commercial manufacture of food.

    There is another specific class of actions not defined but listed as holds, stores, or transports. Common definitions apply here.

    Also, there is a geographical constraint that limits this to any State. What is a State?

    (20) STATE- The term ‘State’ means–

    (A) a State;

    (B) the District of Columbia;

    (C) the Commonwealth of Puerto Rico; and

    (D) any other territory or possession of the United States.

    This is important since we move to the only other entity required to register annually, a foreign food establishment.

    (16) FOREIGN FOOD ESTABLISHMENT- The term ‘foreign food establishment’ means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.

    Look at what has happened here. The Food Establishment custom definition does not apply since the location is specific and “located outside the United States” and does not fall within the confines of a ‘State’. Therefore the exclusions of “(14) Food Production Facility” do not apply.

    This makes this particular entity far more reaching than the restrictive entity of a “Food Establishment” located in a ‘State’.

    What does all this mean?

    If you do not fall under the custom definition of a “Food Establishment” you are not required to register. If you are not required to register then there is no categorization of you as a Category 1 thru 5, you can’t be assigned a registration number, there is no inspection, monitoring, or reporting requirements. This is however not a statement that you are not obligated to practice good health standards.

  2. Besides writing our congressman, what else can we do to help combat this growing problem? Grow our own. Fast. Hope for the best.