President Donald Trump on Aug. 18 signed into law legislation that will make certain types of hearing aids available over the counter to Americans with mild or moderate hearing impairment, requiring the Department of Health and Human Services to determine whether the devices need a 510(k) premarket submission. The 510(k) submissions are required for companies that want to market an FDA Class I, II or III device not subject to a formal premarket approval, in order to demonstrate that products are safe and effective, and substantially equivalent to a legally marketed device. The language was included in the Food and Drug Administration Reauthorization Act, after Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., introduced similar language last Congress that didn’t gain traction (see 1611080028).
The U.S. and Argentina agreed to terms to allow exports of U.S. pork to the South American country for the first time since 1992, President Donald Trump announced Aug. 17. Trump “first raised” the issue with Argentina's President Mauricio Macri during an April 27 meeting in Washington, the White House said. “Pending resolution of any outstanding technical issues,” the agreement will take effect after Argentine food safety officials visit the U.S. and conduct on-site verification of the U.S. meat inspection system, the White House said. Argentina has not allowed pork imports from the U.S. in about 25 years over food safety concerns. The agreement will allow all fresh, chilled and frozen pork and pork products to be exported. Exports could total up to $10 million per year, the White House said. The Trump administration “remains focused” on expanding trade of other agricultural products between the two nations, including beef, poultry and fruits, the White House said.
There is significant room for growth in the U.S.-Argentina trade relationship, particularly in agriculture, Vice President Mike Pence said Aug. 15 during a joint press conference in Buenos Aires with Argentina's President Mauricio Macri. Macri, President Donald Trump and other officials have spoken in the last week about expanding U.S. pork access in Argentina, Pence said. Macri and Pence also discussed lemon imports from Argentina and “the interest” in importing beef from and exporting beef to the country, Pence said. An Animal and Plant Health Inspection Service final rule allowing importation of lemons from northwest Argentina into the continental U.S. took effect May 26 (see 1705020038). “Our hope is that, with the energy that our administration and that President Macri’s administration are placing behind this, we may have a breakthrough soon that will expand the economic relationship between Argentina and the United States, particularly on agricultural goods,” Pence said.
President Donald Trump on Aug. 15 extended the Commerce Department’s authority to control U.S. exports under the Export Administration Regulations through Aug. 17, 2018, the White House announced. The move extends a national emergency associated with the expiration of the Export Administration Act, which initially lapsed in 1994 and has since been renewed annually through executive action. Former President George W. Bush issued Executive Order 13222 to declare the national emergency, and the Aug. 15 Trump executive action affirms that the emergency still exists.
President Donald Trump on Aug. 2 sent to the Senate the nominations of Ted McKinney to be under secretary of agriculture for trade and foreign agricultural affairs and John Mitnick to be general counsel at the Department of Homeland Security, the White House announced. Trump tapped McKinney last month to serve in his nominated post (see 1707240034). McKinney has worked as Indiana Agriculture Department director since 2014.
President Donald Trump on Aug. 2 signed legislation that authorizes new sanctions against Iran, Russia and North Korea, the White House announced. Specifically, the bill directs the president to assess military sanctions on Iran, provides for several economic and cyber-related sanctions against Russia, and provides for several economic sanctions against North Korea. The law also provides sanctions for North Korean cargo and shipping, goods produced through North Korean convict or forced labor, and foreign persons that employ North Korean forced laborers. The legislation requires the State Department to determine whether North Korea meets criteria for designation as a state sponsor of terrorism. In an Aug. 2 statement, Trump said he favors "tough measures" to "punish and deter aggressive and destabilizing behavior."
President Donald Trump is extending for another year the national emergency declared in the 2007 Executive Order 13441, which blocks all property and interests in property in the U.S., that come within the U.S. or within the possession or control of any U.S. person, including any overseas branch, of certain persons who undermine the sovereignty of Lebanon or its democratic processes or institutions, the White House announced.
President Donald Trump sent to the Senate the nominations of Ann Marie Buerkle to chair the Consumer Product Safety Commission; C.J. Mahoney to be deputy U.S. trade representative for investment, services, labor, environment, Africa, China, and the Western Hemisphere; Daniel Kritenbrink to be U.S. ambassador to Vietnam; and Michele Sison to be U.S. ambassador to Haiti, the White House announced July 27.
President Donald Trump has nominated Consumer Product Safety Commission Acting Chairwoman Ann Marie Buerkle to chair the CPSC, and to start a seven-year term on Oct. 27, 2018, the White House announced (here). Buerkle, a Republican, previously represented New York’s 25th congressional district in the U.S. House, and worked as a New York assistant attorney general. During her time as a CPSC commissioner, Buerkle has voted against a safety standard for magnet sets (see 1703070015), spoken out against CPSC reporting requirements and civil penalties as subjective and difficult to understand (see 1606030029), and questioned the constitutionality of CPSC plans to collect user fees from importers to fund a new import screening system (see 1602260050).
President Donald Trump intends to nominate Indiana Agriculture Department Director Ted McKinney to be U.S. Agriculture Department under secretary for trade and foreign agricultural affairs, the White House announced (here). McKinney has worked in his current position since 2014, after working 19 years with Dow AgroSciences, the White House said. USDA created the position earlier this year (see 1705120030).