Food Safety bill by Dingell

Luis of the Fresh Produce Industry Discussion Group passes on this link to the discussion draft of a food safety bill from House Energy and Commerce Chairman John Dingell, D-Mich. The marker bill was released earlier this month, and here is a summary of selected portions of the bill found at the House Energy and Commerce Web site:

Summary of Draft Food and Drug Import Safety Act of 2007
Section 2: Research on Testing Techniques for Use in Inspections of Imported Food Safety; Priority Regarding Detection of Intentional Adulteration
Amends Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) by adding a new section (p) entitled Research on Testing Techniques for Use in Inspection for Imported Food Safety.
Requires the Secretary to provide research on testing techniques and sampling methods for use of inspections on food.
Priority shall be given to research that:
1) Is conducted for the development of tests that are suitable for inspections at U.S. ports of entry.
2) Development of tests that would help detect intentionally adulterated food. Requires reports every six months on how the current research is moving towards the ultimate goal of rapid tests that can detect intentionally adulterated food.

Section 3: Imported Food Inspection User Fees
Amends Chapter VIII of the Federal Food, Drug, and Cosmetic Act by adding Section 801A.
Requires the Secretary to assess and collect user fees on food imported into the United States. Fees will go directly towards import inspections, lab testing on import samples, and research on testing techniques for intentionally adulterated food imports.
Not less than 90 percent of the fees shall be used for inspections.
Not more than 10 percent of the fees shall be used for research.
Fee is assessed on each line item of food, and may not exceed $50 per line.
Secretary granted authority to waive or reduce fee where the Secretary finds the fee to be paid will exceed the present and future costs incurred in carrying out inspections.

Section 5: Authority to Restrict Food Importation to Specific Ports of Entry
Amends Section 801 of the Federal Food, Drug, and Cosmetic Act.
The Secretary shall restrict the importation of food to ports of entry that are located in a metropolitan area with a Food and Drug Administration laboratory.
The Secretary may waive this requirement that the importation of such food through such port will not increase the probability that such food will cause serious, adverse health consequences or death; [and/or] there is a reasonable probability that the type of food will not cause serious, adverse health consequences or death
The Secretary shall transition to such a system within 5 years of enactment.

Section 6: Country of Origin Labeling
Amends Chapter IV of the Federal Food, Drug, and Cosmetic Act by adding a new Section 417.
The Secretary shall promulgate regulations within 180 days of enactment to require the labeling of food to identify the country of origin of the food.
Section 7: Safe and Secure Food Importation Program

Amends Chapter VIII of the Federal Food, Drug, and Cosmetic Act by adding a new Section 805.
Not later than 2 years after the date of enactment, the Secretary shall create a voluntary program for companies that import food and agree to abide by specific food safety and security guidelines to receive expedited movement of that company’s food through the inspection process.
Factors that the Secretary shall take into account include:
1) e company’s personnel importing the food;
2) the physical and procedural safety and security of a company’s food supply chain;
3)Sufficiency of access controls for food and ingredients purchased by a company;
4)Need for tracking and maintaining records on food and ingredients purchased by such a person or moved through the supply chain;
5)Documentation processing through a company’s supply chain;
6)Access by the Secretary to a company’s business records for review; and
7)A company’s vendor and supplier information.


Section 8: Enhanced Civil Monetary Penalties
Amends Section 303 of the Federal Food, Drug, and Cosmetic Act.
Increases civil penalties for manufacturers or importers that violate the Act. Penalties are raised to $100,000 in the case of an individual, $500,000 in the case of a company introducing or delivery, not to exceed $1 million for all adjudications in a single proceeding.
Section 9: Continued Operation of Field Laboratories
Bars the Secretary from terminating or consolidating any of the current 13 FDA field laboratories.
Bars the Secretary from terminating or consolidating any of the current 20 FDA district offices or any of the inspection or compliance functions of any of the 20 district offices.
In preparing any reorganization plan, the Secretary shall consult with personnel and unions to be affected by the plan.
Once published, the Secretary must submit a report detailing the Food and Drug Administration field organization to the Comptroller General, the Committee on Energy and Commerce, and the Senate Committee on Health, Education, Labor, and Pensions.
Government Accountability Office shall study the cost effectiveness of such a plan and its impact on food, drug, and other products regulated by FDA. GAO shall provide the study to the Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions.
Within 180 days of receipt of the GAO study, Congress may disapprove of the field organization plan.
Section 10: Recall Authority
Amends Chapter IV of the Federal Food, Drug, and Cosmetic Act by adding a new Section 417.
If the Secretary finds that there is a reasonable probability that a food would cause serious, adverse health consequences or death, the Secretary may issue an order requiring the appropriate person to cease distribution. Within 10 days of the order to cease distribution, the person has the opportunity for an informal hearing on the actions required by the order and on whether the order should be amended to require a recall. All food intended for consumption that is offered for importation into the United States would be subject to the same standards applied to such food in the United States. Any food intended for consumption that does not meet all the standards referred to in subsection (a) shall not be permitted entry into the United States. The Secretary will enforce this provision through appropriate random inspections, sampling, and testing. Each foreign facility from which food is imported into the United States must obtain a certification issued by the Secretary stating that the facility maintains a program using reliable analytical methods to ensure compliance with all U.S. standards.

TK: Meanwhile, the topic of food imports continues to get a lot of play. Here is coverage from The Oregonian on the topic of problem food imports.