S 510 - FDA Food Safety Modernization Act - National Key Vote
Issues Related to S 510
Nov. 30, 2010(Key vote)
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Title: FDA Food Safety Modernization Act
Vote Smart's Synopsis:
Vote to pass a bill that amends food safety laws.
- Specifies that if the Secretary determines, based on gathered information, that there is a reasonable probability that ingesting an article of food will cause series adverse health consequences or death, he or she shall provide the responsible party with an opportunity to stop distribution of or recall the food, and if the responsible party refuses to recall or stop distribution the Secretary may require them to do so (Sec. 206).
- Requires the Secretary of Health and Human Services to identify high-risk facilities and allocate resources to inspect those facilities according to the risks, which shall be based on the following factors (Sec. 201):
- The known safety risks of the food manufactured, processed, packed, or held in the facility;
- The compliance history of the facility;
- The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls;
- Whether the food at the facility meets the criteria for priority;
- Whether the food at the facility has received certification; and
- Any other criteria deemed necessary and appropriate by the Secretary.
- Requires that beginning on the date of enactment of this bill the Secretary shall increase the frequency of inspections of all facilities, as follows (Sec. 201):
- For domestic high-risk facilities, at least one inspection shall be conducted within the 5-year period following the enactment of this bill, and at least every 3 years thereafter;
- For domestic non-high-risk facilities, which include all domestic facilities that are not classified as high-risk, at least one inspection shall be conducted within the 7-year period following the enactment of this bill, and at least every 5 years thereafter;
- For foreign facilities, at least 600 inspections shall be conducted within 1 year following the enactment of this bill; and
- For foreign facilities, twice the number of inspections conducted the previous year shall be conducted each year for 5 years, beginning the year after enactment of this bill.
- Authorizes the Secretary of Health and Human Services to inspect records related to food if there is a possibility that the use of or exposure to food will cause "serious adverse health consequences or death to humans or animals" (Sec. 101).
- Authorizes the Secretary to suspend the registration of a facility if it is found that food manufactured, packed, processed or received at that facility has a "reasonable probability" of causing serious adverse health consequences or death (Sec. 102).
- Prohibits all facilities whose registrations have been suspended to import or export food into the United States (Sec. 102).
- Requires owners, operators and those in charge of a facility to evaluate hazards that could affect the packaging, processing or manufacturing of foods and identify, implement, and document "preventive controls" to minimize or prevent such hazards, with the following exceptions including, but not limited to (Sec. 103):
- If the facility is a "very small business"; or
- If the facility has average annual sales of less than $500,000.
- Requires the Secretary, no later than 18 months after the enactment of this bill, to promote regulations to (Sec. 103):
- Establish science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventive controls and documenting the implementation of preventative controls; and
- Define the terms "small business" and "very small business" as they apply to this act.
- Requires the Secretary of Health and Human Services, in conjunction with the Secretary of Agriculture, to publish proposed rules for establishing "science-based minimum standards" for the safe production and harvesting of fruits and vegetables within one year of the enactment of this bill (Sec. 105).
- Requires the Secretary to assess and collect fees from the following (Sec. 107):
- The responsible party for each domestic facility or the United States agent for every foreign facility to cover re-inspection costs;
- The responsible party for each domestic facility or an importer that does not comply with a recall order;
- Importers participating in the voluntary qualified importer program to cover administrative costs; and
- Each importer subject to re-inspection to cover re-inspection costs.
- Requires the Secretary of Health and Human Services to develop guidelines, no later than 1 year after the enactment of this bill, to be used on a voluntary basis to manage the risk of food allergy and anaphylaxis in schools and early childhood education facilities (Sec. 112).
- Requires the Secretary of Health and Human Services to notify the Secretary of Homeland Security when a food is denied entrance into the United States so that such food can be denied at any other port of entry (Sec. 115).
- Specifies that nothing in this act shall apply to a facility that (Sec. 116):
- Is required to obtain a permit or to register with the Secretary of the Treasury in order to do business in the United States; and
- Is engaged in manufacturing, processing, packing, or holding of 1 or more alcoholic beverages.
- Requires the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, to allocate resources to inspect any food item imported into the United States according to the known safety risks of the food, and the compliance history of the importer (Sec. 201).
- Requires the Secretary of Health and Human Services to perform the following no later than 2 years after the enactment of this bill (Sec. 202):
- Establish a program for the testing of food by accredited laboratories;
- Establish a publicly available registry of accredited laboratories and accreditation bodies recognized by the Secretary; and
- Require, as a condition of recognition or accreditation, recognized accredited bodies to report to the Secretary any changes that might affect accreditation.
- Requires that, no later than 30 months after the date of enactment of this bill, food testing be conducted by accredited laboratories, and results from the food tests be sent directly to the Food and Drug Administration, unless the Secretary determines that such results do not contribute to the protection of public health (Sec. 202).
- Requires the Secretary, within 270 days of the enactment of this bill, to establish pilot projects in coordination with the food industry to explore methods that would rapidly identify food recipients to prevent or mitigate a foodborne illness outbreak (Sec. 204).
- Defines a "foodborne illness outbreak" as an occurrence of 2 or more similar illnesses resulting from ingesting a certain food (Sec. 205).
- Requires the Secretary, acting through the Director of Disease Control and Prevention, to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting and usefulness of data (Sec. 205).
- Requires the Secretary to publish a press release regarding a food recall in order to inform the consumers and retailers to whom the article of food was or may have been distributed, and that this press release shall contain the following minimum information (Sec. 206):
- The name of the food;
- A description of the risk associated with the food; and
- Information about similar articles of food that are not affected by the recall.
- Requires the Administrator of the Environmental Protection Agency in coordination with the Secretaries of Health and Human Services, Homeland Security, and Agriculture, to provide support for and technical assistance to state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency (Sec. 208).
- Authorizes the Secretary to do the following (Sec. 306):
- Enter into agreements and arrangements with foreign governments to facilitate the inspection of foreign facilities; and
- Direct resources to inspections of foreign facilities, suppliers, and food types, especially those that present a high risk, to help ensure food safety and security.
Legislation - Introduced (Senate) - March 3, 2009
Title: FDA Food Safety Modernization Act
- Lamar Alexander (TN - R)
- Jeff Bingaman (NM - D) (Out Of Office)
- Richard M. Burr (NC - R)
- Roland W. Burris (IL - D) (Out Of Office)
- Robert P. 'Bob' Casey Jr. (PA - D)
- Clarence Saxby Chambliss (GA - R) (Out Of Office)
- Christopher J. 'Chris' Dodd (CT - D) (Out Of Office)
- Michael B. 'Mike' Enzi (WY - R)
- Al Franken (MN - D) (Out Of Office)
- Kirsten E. Gillibrand (NY - D)
- Judd A. Gregg (NH - R) (Out Of Office)
- Thomas 'Tom' Harkin (IA - D) (Out Of Office)
- Orrin G. Hatch (UT - R)
- John H. 'Johnny' Isakson (GA - R)
- Edward E. 'Ted' Kaufman (DE - D) (Out Of Office)
- Edward M. 'Ted' Kennedy Sr. (MA - D) (Out Of Office)
- Amy Klobuchar (MN - D)
- Robert 'Bob' Menendez (NJ - D)
- E. Benjamin 'Ben' Nelson (NE - D) (Out Of Office)
- Thomas S. 'Tom' Udall (NM - D)
- David B. Vitter (LA - R) (Out Of Office)