Hearing Quickly Held on New Bill for Imported Food and Drug User Fees, Port Restrictions on Food Imports, Etc.

The House Energy and Commerce Committee's Subcommittee on Health held a hearing on H.R. 3610 on September 26, 2007.

According to a House Energy and Commerce Committee summary, highlights of H.R. 3610 include (partial list):

Imported food and drug inspection user fees. H.R. 3610 would require the Health and Human Services (HHS) Secretary to assess and collect user fees on food imported into the U.S. For food imports, the fee would be assessed on each line item, and would not be able to exceed $50 per line.

H.R. 3610 would also require the HHS Secretary to assess and collect user fees on drugs imported into the U.S. For drug imports, the fee would be assessed on each line item, and would not be able to exceed $1,000 per line item.

H.R. 3610 would allow the HHS Secretary to waive or reduce the food and drug user fees under certain conditions.

Food imports restricted to specific ports of entry. H.R. 3610 would require the HHS Secretary to restrict the importation of food to ports of entry that are located in a metropolitan area with a Food and Drug Administration (FDA) laboratory. This requirement could be waived under certain circumstances. The time period to transition to such a system would be five years.

Origin labeling for food, drug, devices. H.R. 3610 would require the HHS Secretary to promulgate regulations within 180 days of enactment to require the labeling of foods, drugs, and devices to identify the country of origin.

Voluntary program. H.R. 3610 would require the HHS Secretary, not later than 2 years after the date of enactment, to 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.

Increased civil monetary penalties. H.R. 3610 would increase civil penalties for manufacturers or importers that violate the Federal Food, Drug, and Cosmetic Act. Penalties would be raised to $100,000 in the case of an individual, $500,000 in the case of certain companies, not to exceed $1 million for all adjudications in a single proceeding.

Field laboratories. H.R. 3610 would bar the HHS Secretary from terminating or consolidating any of the current (1) 13 FDA field laboratories and (2) 20 FDA district offices or any of the inspection or compliance functions of any of the 20 district offices. H.R. 3610 would also require the HHS Secretary to submit a report regarding FDA's field organization to specified congressional committees, etc.

Recall authority. H.R. 3610 would allow the HHS Secretary to issue an order requiring the appropriate person to cease distribution if the Secretary finds that there is a reasonable probability that a food would cause serious, adverse health consequences or death. Within 10 days of the order to cease distribution, the person would have 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. H.R. 3610's recall authority does not include recall of a food from individuals.

Inspections, etc. H.R. 3610 would require all food intended for consumption that is offered for importation into the U.S. to be subject to the same standards applied to such food in the U.S. Any food intended for consumption that does not appear to meet such standards would not be permitted entry into the U.S. This would be enforced through random inspections, sampling, and testing.

Foreign facility certification. According to H.R. 3610, no food would be permitted entry into the U.S. from a foreign facility in a foreign country unless there is: (1) a certification for such facility; or (2) a certification for such country where a facility is located.

Labeling for carbon monoxide. H.R. 3610 would require meat, poultry or seafood intended for human consumption that includes carbon monoxide to affect coloring to bear a label (containing specified language) that is prominently and conspicuously displayed for the ordinary person to understand. This provision would go into effect 30 days after enactment. H.R. 3610 would allow the HHS Secretary, after five years, the discretion to issue alternative labeling requirements.

H.R. 3610 (as introduced) available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h3610ih.txt.pdf.

House Energy and Commerce committee press release (dated 09/20/07) available at http://energycommerce.house.gov/Press_110/110nr88.shtml.

House Energy and Commerce committee summary of H.R. 3610, available at http://energycommerce.house.gov/China%20Food%20Safety/Summary%20of%20Bill.pdf.

BP Note

At their September 24-25, 2007 Government Affairs Conference, the National Customs Brokers and Forwarders Association of America (NCBFAA) issued a position paper expressing concerns about H.R. 3610, noting that the legislation, among other things, fails to recognize the magnitude and diverse range of FDA-regulated products, etc.