The Food and Drug Administration is considering refusing admission of imports of active pharmaceutical ingredients (APIs) and finished pharmaceuticals from Boehringer-Ingelheim Pharma’s Ingelheim am Rhein, Germany facility. According to an FDA warning letter, an agency inspection found serious violations of current good manufacturing practice requirements for both types of products at the facility.
On May 21, the Foreign Agricultural Service posted the following GAIN reports:
The Bureau of Industry and Security will hold a webinar May 29 at 2:30 p.m. on certain provisions of the final rules on initial implementation of export control reform. The webinar will take the place of the normal Wednesday teleconference held by Assistant Secretary Kevin Wolf. Topics will include new provisions with respect to de minimis and the foreign direct product rule under the Export Administration Regulations, which will become effective October 15, 2013. BIS is charging $35 for the webinar. Register (here).
The Bureau of Industry and Security posted two new decision tools for use by exporters in understanding the Export Administration Regulations. One decision tool covers the new “specially designed” definition (here) adopted as part of BIS’ final rule on initial implementation of export control reform. The other assists exporters in applying the Commerce Control List order of review (here). Both tools are effective for exports beginning Oct. 15.
The U.S. District Court for Northern California extended the time period for the Food and Drug Administration and the Center for Food Safety to come up with a timeline for implementation of Food Safety Modernization Act regulations. The District Court had ordered FDA to adhere to a schedule for FSMA rulemaking in April, due to missed deadlines for rules that the court had deemed illegal (see 13042402). But concerned that its own dates would be arbitrary, the court instead ordered the Center for Food Safety and the Food and Drug Administration to agree to a timeline by May 20. The new deadline for the rulemaking schedule is June 10.
A listing of recent antidumping and countervailing duty messages from the International Trade Administration posted to CBP's website May 21, along with the case number(s) and CBP message number, is provided below. The messages are available by searching for the listed CBP message number at addcvd.cbp.gov. (CBP occasionally adds backdated messages without otherwise indicating which message was added. ITT will include a message date in parentheses in such cases.)
A Texas customs broker pleaded guilty May 14 to entry of misclassified goods, smuggling, and making false statements, in connection with a scheme where he defrauded both CBP and his clients. According to court documents, Alejandro Santos of Laredo misidentified goods duty free, and then collected the full amount of duties actually owed to CBP from clients and pocketed the difference.
Customs reauthorization legislation - an actual, tangible bill - is necessary to help shift CBP's focus back to trade facilitation and codify progress the agency has already made, Senators and industry representatives said at a May 22 hearing on S-662, the customs bill introduced by Finance Committee leaders in March. "The real question is how we reinvigorate this commitment to the trade side of CBP," said Sen. Ron Wyden, D-Ore., at the Finance Committee hearing. Senators have tried politely asking CBP to do this, through letters and in hearings, but "that hasn't worked," Wyden said. "That's why we felt we needed to have an actual piece of legislation."
Commerce Department Under Secretary for International Trade Francisco Sanchez will host a workshop with the U.S. textile and apparel industries on NAFTA compliance and Mexico’s NAFTA origin verification procedures May 29, alongside Mexican Servicio de Administracion Tributaria (SAT) chief Aristóteles Núñez. The workshop will be held at SAT headquarters in Mexico City from 10 a.m. to noon. Agenda items include NAFTA Chapter 5 rights, obligations and consequences when filling out and signing a NAFTA Certificate of Origin; verification procedures technical session including SAT´s new procedures designed to facilitate compliance; and how SAT is resolving current cases. Passports will be required to attend.
The International Trade Commission is publishing notices in the May 21 Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will appear in another ITT article):