February 5 2013 Issue
FDA Affirms Rule Increasing Chance of Administrative Detentions of Imported Food
The Food and Drug Administration has adopted without change a May 2011 interim final rule concerning administrative detentions of potentially adulterated or misbranded human or animal food. As specified by the Food Safety Modernization Act, this rule allows the FDA to order administrative detention of any article of food that is found during an inspection, examination or investigation if it has reason to believe that the article of food is adulterated or misbranded. Previously the FDA was only able to order such detentions if it found credible evidence or information indicating that the article of food presented a threat of serious adverse health consequences or death to humans or animals.
The FDA believes this authority will further help it to prevent potentially harmful food from reaching U.S. consumers. The agency noted in the interim final rule that it had never administratively detained an article of food despite having the authority to do so but that under the new criteria it is more likely to use administrative detention in situations where it might previously not have; e.g., where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
In response to comments on the interim final rule the FDA has provided the following information.
- Decisions on whether the FDA has “reason to believe that an article of human or animal food is adulterated or misbranded” are fact-specific and will therefore be made on a case-by-case basis.
- The FDA will continue to use its advisory action tools, such as warning letters and untitled letters, to achieve voluntary compliance and voluntary corrective action to address adulteration or misbranding violations, as appropriate.
- Given the procedural and substantive differences between administrative detention and detention that occurs during import admissibility review, confusion between the two is unlikely; however, when the FDA gives written notice in either circumstance it will make clear which type of detention is involved.
- The FDA intends to issue notice of termination of administrative detention on the same day the decision is made whenever practicable. If the FDA fails to issue a termination notice and the detention period expires (a maximum of 30 days from the date the detention was ordered) the detention is deemed to be terminated.
- The responsibility for paying the storage costs of administratively detained food is a matter to be resolved between the private parties involved. An owner, operator or agent in charge of the place where the food is located can request modification of a detention order to allow the food to be moved or destroyed if they do not want to store it.
Trade Liberalization Talks Between U.S. and Taiwan to Resume in March
U.S. and Taiwanese officials announced Feb. 1 that they will resume discussions under their bilateral Trade and Investment Framework Agreement by the end of March. Although the TIFA talks have been suspended since 2007 due largely to Taiwan’s restrictions on imports of beef containing a growth additive commonly used by U.S. producers, that issue was resolved last July. An agenda for the upcoming discussions has not been finalized but could include issues such as investment, intellectual property rights, pharmaceutical and medical equipment pricing, and technical barriers to trade.
While Taiwanese officials see the TIFA discussions as a steppingstone to broader initiatives such as membership in an eventual Trans-Pacific Partnership Agreement, the U.S. is taking a more cautious approach. De facto U.S. Ambassador to Taiwan Raymond Burghardt said the upcoming talks will be “a vehicle for regaining confidence in our bilateral trade relationship” and that the U.S. will want to “see how things go” before considering adding Taiwan to the TPP or a possible U.S.-Taiwan free trade agreement. Burghardt added that Taiwan will need to enact further economic and trade reforms before it can be considered “a credible candidate for that kind of tough, comprehensive agreement on trade and investment.”
AD/CV Duty Order Issued on Hangers from Vietnam
Agency: International Trade Administration.
Commodity: Steel wire garment hangers.
Nature of Notice: Issuance of antidumping and countervailing duty orders.
Details: The merchandise subject to this order is steel wire garment hangers fabricated from carbon steel wire, whether or not galvanized or painted, whether or not coated with latex or epoxy or similar gripping materials, and whether or not fashioned with paper covers or capes (with or without printing) or nonslip features such as saddles or tubes. Subject products are currently classified under HTSUS 7326.20.0020 and 7323.99.9080. Specifically excluded are (a) wooden, plastic and other garment hangers not made of steel wire; (b) steel wire garment hangers with swivel hooks; (c) steel wire garment hangers with clips permanently affixed; and (d) chrome plated steel wire garment hangers with a diameter of 3.4 millimeters or greater.
ITA Seeks U.S. Companies to Export Goods or Services for Air Transportation Systems
The International Trade Administration is requesting responses from U.S. vendors capable of exporting goods or services for the implementation of Next Generation Air Transportation System (NextGen) solutions that meet the requirements of the International Civil Aviation Organization’s Aviation System Block Upgrade initiative. The NextGen solutions address the ASBU-designated performance improvement areas of airport operations, globally interoperable systems and data, optimum capacity and flexible flights, and efficient flight paths. The ITA is developing a Web-based NextGen Solutions Vendors Guide intended to be used by foreign air navigation service providers, airport operators and government authorities to identify U.S. goods and services that can be used to help implement ICAO-consistent NextGen solutions.
Vendors interested in being listed should submit their company name, Web site address, contact information, and aviation solution category(ies). Responses are due no later than March 29 and may be submitted by phone or email (202–482–4125; e-mail NextGenVendors@trade.gov). The ITA notes that responses will serve as a certification that the vendor is a U.S. exporter as defined by 15 USC 4721(j); i.e., a U.S. citizen; a corporation, partnership or other association created under the laws of the U.S. or of any state; or a foreign corporation, partnership or other association more than 95% of which is owned by persons described above, that exports or seeks to export goods or services produced in the U.S.
22 Individuals Barred from Defense Trade for Export Violations
The Department of State has imposed statutory debarment under the International Traffic in Arms Regulations on 22 persons convicted of violating or conspiring to violate Section 38 of the Arms Export Control Act. As a result, these individuals are prohibited from participating directly or indirectly in the export of defense articles, including technical data, or in the furnishing of defense services for which a license or other approval is required. In addition, any person who has knowledge that another person is subject to debarment or is otherwise ineligible may not, without disclosure to and written approval from State’s Directorate of Defense Trade Controls, participate directly or indirectly in any ITAR-controlled export in which such ineligible person may benefit or in which they may have a direct or indirect interest.
The period for debarment is generally three years from the date of conviction. Export privileges may be reinstated only at the request of the debarred person followed by the necessary interagency consultations, after a thorough review of the circumstances surrounding the conviction, and a finding that appropriate steps have been taken to mitigate any law enforcement concerns. Unless export privileges are reinstated, the person remains debarred.
Foreign Regulatory Changes Could Affect Exports of Cables, Foods, Oil/Gas Industry Items
According to the National Institute of Standards and Technology, the World Trade Organization has been notified of regulatory changes that may affect exports of specific products to the following countries. For information on how these restrictions may affect your business, contact ST&R.
Israel – revised mandatory standards on electric cables, cords and insulated conductors (comments due by March 29)
Kuwait – draft technical regulation on squash seeds (comments due by March 31)
Mexico – Jan. 8 effective date of amended official standard on food and beverages for infants and young children
Saudi Arabia – fuel dispensers, sound level meters, automatic gravimetric filling instruments, gas chromatographic systems, dynamic measuring systems for liquids other than water, and radiation protection instrumentation (comments due by March 31)
Ex-Im Bank Asked to Finance Exports of Aircraft to UAE, Morocco, Israel
The Export-Import Bank of the United States has received separate applications for final commitment for long-term loans or financial guarantees to support the export of U.S.-manufactured aircraft, as follows.
- Boeing 777 cargo aircraft to Dubai, United Arab Emirates, to provide cargo services globally
- Boeing 737 aircraft to Morocco to be used for medium-haul passenger air service between Morocco and destinations in Europe, Africa and the Middle East
- Boeing 737 aircraft to Israel to be used for short-haul passenger air service between Israel and destinations in Europe
Comments on these applications are due no later than March 4.
Trade Liberalization Talks Between U.S. and Taiwan to Resume in March