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Volume 16, Issue 153
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Monday, August 3, 2009
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Food Safety Reform Legislation Clears House on Second Try
The House of Representatives approved by a 283-142 vote July 30 a broad food safety reform bill that imposes new requirements on companies in the food supply chain. According to the House Energy and Commerce Committee, the measure, which was reportedly amended several times in the past week, includes the following provisions.
Registration. All food facilities operating within the U.S. or importing food into the U.S. must register with the Food and Drug Administration and pay a $500 registration fee each year (capped at $175,000 per company). Registrants are required to provide additional information pertaining to the facility, including contact information, the primary purpose and business activity of the facility, all trade names under which the facility conducts business related to food, and, for foreign facilities, the U.S. agent.
All customs brokers with respect to the importation of food must register with the FDA but are not required to pay a registration fee.
ID Numbers. Unique identification numbers will be created for all food facilities, importers and customs brokers required to register. The FDA is authorized to issue guidance specifying the unique numerical identifier system to be used, but in developing such guidance with respect to importers and customs brokers the FDA must consult with U.S. Customs and Border Protection and take into account the utilization of existing unique identification schemes and compatibility with CBP’s automated systems.
The FDA is required to refuse admission of an imported food into the U.S. for interstate commerce unless the unique facility identifiers are provided.
Entry Filings. The submission of inaccurate or incomplete information relating to imported food, and the failure to submit required information related to imported food, are prohibited acts. The FDA may require the submission of documentation or other information for articles of food that are imported or offered for import into the U.S. To the extent that the collection of documentation or other information involves CBP efforts or resources, the FDA must consult with CBP.
Safety Plans. Foreign and domestic food facilities must have written safety plans in place to identify and mitigate hazards. As part of this plan, the owner, operator or agent must conduct a hazard analysis; identify, implement and validate effective preventive controls; monitor preventive controls; institute corrective actions when monitoring shows that preventive controls have not been properly implemented or were ineffective; conduct verification activities; maintain records of monitoring, corrective action and verification; and reanalyze for hazards. The plan must also include a description of the facility’s procedures for recordkeeping, recall, trace back, supply chain safety and science-based performance standards. Safety plans and food facility records will be subject to review by FDA inspectors and third-party certifiers.
Inspections. Each registered high-risk foreign and domestic food facility must be inspected at least once every six to 12 months, each registered low-risk facility must be inspected at least once every 18 months to three years, and each registered warehouse must be inspected at least once every five years. Refusing, impeding or delaying an inspection is prohibited.
The FDA must report to Congress each year on the number of facilities inspected and the costs of implementing the risk-based inspection schedule over the preceding 12 months. The FDA can recommend changes to the inspection schedule after the second year and can implement any recommended changes with respect to low-risk facilities and warehouses six months after submitting its third report.
Recordkeeping. Each person who produces, manufactures, processes, packs, transports, distributes, receives or holds an article of food in the U.S. or for import into the U.S. must allow FDA-authorized personnel to access and copy all records relating to such article with respect to whether it may be adulterated, misbranded or otherwise in violation of this bill during an inspection. The FDA must issue regulations requiring such records to be established and maintained for no longer than three years.
Import Certification. Certain imported foods must be accompanied by a certification that they comply with specified requirements of the Federal Food, Drug and Cosmetic Act. The FDA will require certification for food imported from a particular country or region if (a) certification would assist it in determining whether to refuse to admit that food, (b) for a type of food that could pose a significant risk to health, certification would assist it in determining whether the food poses such a risk, or (c) for an article imported from a particular country, there is an agreement between the FDA and the government of that country providing for such certification. Certifications must be provided by a qualified certifying entity; i.e., an agency or representative of the government of the country from which the article originated, an individual or entity determined by the FDA or an accredited body recognized by the FDA.
Notification and Recall. Food facilities, importers, customs brokers and filers that have reason to believe an article of food is adulterated or misbranded in a manner that presents a reasonable probability that the use or consumption of, or exposure to, that article will cause a threat of serious adverse health consequences or death to humans or animals must notify the FDA of the identity and location of the article as soon as practicable. The FDA may request that any person who distributes an article of food that it has reason to believe is adulterated, misbranded or otherwise in violation of this bill
voluntarily recall that article. If the FDA has reason to believe that the use or consumption of, or exposure to, an article of food may cause serious adverse health consequences or death to humans or animals, it may require any person who distributes that article to immediately cease distribution . In addition, if the FDA obtains credible evidence or information that an article of food subject to an order to cease distribution presents an imminent threat of serious health consequences or death to humans or animals, it may issue an emergency order requiring any person who distributes that article to immediately recall it.
Expedited Imports. The FDA is authorized to establish, in coordination with CBP, a program to facilitate food imports for importers who verify that each facility involved in the production, manufacture, processing, packaging and holding of their foods has been determined to be in compliance with food safety and security guidelines developed by the FDA in consultation with CBP. The FDA is required to take into account other relevant federal programs in developing food safety and security guidelines.
Traceability. The FDA must issue trace back regulations that enable it to identify each person who grows, produces, manufacturers, processes, packs, transports, holds or sells a food item in as short a timeframe as practicable but within no more than two business days. The FDA must conduct a feasibility study, public meetings and one or more pilot projects prior to issuing these regulations.
Country of Origin Labeling. All processed food labels must indicate the country in which final processing occurred, but foods already in compliance with country of origin requirements from CBP will be deemed in compliance. In addition, all non-processed foods must be labeled with their country of origin, but such foods that already list the country of origin pursuant to Farm Bill requirements will be deemed in compliance. The FDA must promulgate implementing regulations in accordance with CBP laws and regulations with respect to country of origin marking to ensure that the country of origin of final processing for FDA purposes is consistent with the country of origin for CBP marking purposes.
Lab Testing. The FDA is required to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. In addition, labs must send certain test results directly to the FDA.
Enforcement. The FDA’s ability to administratively detain tainted food products is enhanced by allowing it to detain any article of food it has reason to believe is adulterated, misbranded or otherwise in violation of this bill. Criminal and civil penalties are strengthened.
Exportation Certificate. The FDA may impose a fee for the issuance of export certificates for foods and animal feeds.
Infant Formula. Any manufacturer of a new infant formula must submit certain safety information regarding new ingredients, and the FDA is granted additional time to review such new ingredients.
Bisphenol A. The FDA is required to notify Congress no later than Dec. 31, 2009, whether the available scientific data supports a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women and adults, for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers. If the FDA is unable to make such a determination it must notify Congress of the actions it intends to take to protect the public health.
Ceramic Tableware and Cookware. The bill imposes new requirements on ceramic tableware or cookware that includes a glaze or decorations containing lead for an intended functional purpose. Such products and their packaging must bear the statement, “This product is made with lead-based glaze consistent with Food and Drug Administration guidelines for such lead” or the product must comply with FDA regulations applicable to ornamental and decorative ceramic ware.
Source Document 1...
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