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October 23 2012 Issue

Tuesday, October 23, 2012
Sandler, Travis & Rosenberg Trade Report

FDA Solutions Group Helps Food Industry With New FSMA Requirements

FDA Solutions Group LLC, a Miami-based regulatory compliance company, has opened its doors just in time to assist the thousands of food industry companies affected by the new re-registration requirements of the Food Safety Modernization Act.

Under FSMA Section 102, all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the Food and Drug Administration before the end of 2012. FSMA Section102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. In addition to requiring all food facilities to re-register in 2012, FSMA requires re-registration every two years thereafter.

FDA Solutions Group is hardly a newcomer when it comes to the process of assisting new and existing food manufacturers and food importers to meet FDA registration requirements. Not only does the company have a robust and efficient registration system already in place, its principals head up the FDA practice of Sandler, Travis & Rosenberg P.A., a customs, international trade and business law firm that has been a leader in helping clients comply with FDA requirements for 35 years.

FDA Solutions Group operates independently and offers client companies the benefit of its principals’ years of experience, knowledge and expertise in FDA regulatory matters.

FDA Solutions Group doesn’t charge law firm prices for its services because it is not a law firm. Rather, the company’s fees are very competitive, in keeping with its mission of providing cost-effective registration and agency services to companies affected by the new FSMA registration rules.

Along with providing registration services, FDA Solutions Group acts as U.S. agent for its clients, a designation that now has become a risky proposition for providers who accepted U.S. agent status in the past. 

Information about FDA Solutions Group’s FSMA registration services and its other offerings can be found here or by calling (305) 702-3161.

U.S.-Panama FTA to Take Effect Oct. 31

The U.S. and Panama exchanged letters Oct. 22 indicating that all steps necessary for the implementation of their joint free trade agreement have now been taken. As a result, this FTA is scheduled to take effect Oct. 31.

According to the Office of the U.S. Trade Representative, as of that date Panama will immediately eliminate its import tariffs on more than 86% of U.S. consumer and industrial products, including information technology equipment, agricultural and construction equipment, aircraft and parts, medical and scientific equipment, environmental products, pharmaceuticals and fertilizers. Nearly half of U.S. exports of agricultural commodities to Panama will immediately become duty-free as well, including wheat, barley, soybeans, high-quality beef, bacon, and almost all fruit and vegetable products, and most of the remaining tariffs will be eliminated within 15 years. The FTA will also provide significant new access to Panama’s $22 billion services market and “includes important disciplines relating to customs administration and trade facilitation, technical barriers to trade, government procurement, investment, telecommunications, electronic commerce, intellectual property rights, and labor and environmental protection.” 

Trade Issues Facing Machinery Manufacturers to be Focus of Dec. 4 Conference

The Department of Commerce is hosting a conference Dec. 4 in Washington, D.C., on bilateral and multilateral international trade issues affecting the U.S. machinery manufacturing industries, with emphasis on tariff and non-tariff barriers to trade and global market access.

The DOC notes that machinery manufacturing is one of the largest and most competitive sectors of the U.S. manufacturing economy, with more than $160 billion in exports in 2011, and has a broad economic impact. For example, machinery industries provide technology for many other manufacturing and service industries and sales of many types of machinery are accompanied by high-value services such as specialized architecture, engineering and logistics.

As a result, DOC’s Office of Transportation and Machinery has been working for several months to identify significant trade barriers facing U.S. machinery manufacturer exporters in foreign markets. The upcoming conference will allow OTM to review what it has learned with private-sector stakeholders and to further refine its understanding of the market access challenges they face. 

Corrected Limit on Duty/Quota-Free Apparel Imports from Ecuador

The Committee for the Implementation of Textile Agreements has issued a notice correcting the quantitative limitation on imports of qualifying apparel articles eligible for duty- and quota-free treatment under the regional fabric provision of the Andean Trade Promotion and Drug Eradication Act. For the period Oct. 1, 2012, through July 31, 2013, this limit will be set at 1,239,899,947 square meters equivalent (not 1,341,030,128 as previously stated), and apparel articles entered in excess of this quantity will be subject to otherwise applicable tariffs. This limit applies only to imports from Ecuador, which is the only remaining ATPDEA beneficiary.

The regional fabric provision applies to apparel articles sewn or otherwise assembled in one or more ATPDEA beneficiary countries from fabrics or fabric components formed, or from components knit-to-shape, in one or more ATPDEA beneficiary countries from yarns wholly formed in the U.S. or one or more ATPDEA beneficiary countries (including fabrics not formed from yarns, if such fabrics are classifiable under HTSUS 5602 and 5603 and are formed in one or more ATPDEA beneficiary countries). Such apparel articles may also contain certain other eligible fabrics, fabric components or components knit-to-shape.

Medical Supply Company Fined for Exports to Iran

The Treasury Department’s Office of Foreign Assets Control has announced that a U.S. medical supply company has agreed to pay $18,900 to settle potential civil liability for alleged violations of the Iranian Transactions Regulations. OFAC alleged that the company exported $5,241 in goods or services to a person in a third country with knowledge or reason to know that they were intended specifically for transshipment to Iran.

OFAC states that the base penalty amount for the alleged violations is $21,000 and that the settlement amount reflects consideration of the following facts and circumstances.

- the conduct demonstrated reckless disregard for U.S. sanctions requirements and involved a pattern of concealment whereby the company masked the identities of its Iranian customers

- management level staff were involved with and/or were aware of both the reckless conduct and the fact that the goods or services were destined for Iran

- the company did not have a compliance program in place at the time of these alleged violations and did not voluntarily self-disclose to OFAC

- the exports at issue likely would have been licensed by OFAC under existing licensing policy

- the company has not been the subject of prior OFAC enforcement action and cooperated with this investigation 

New Foreign-Trade Zone Established in West Tennessee

The Foreign-Trade Zones Board has authorized the establishment of FTZ 283 under the alternative site framework with a service area of Dyer, Gibson, Haywood, Lake, Lauderdale, Madison, Obion and Tipton counties in Tennessee, adjacent to the Memphis U.S. Customs and Border Protection port of entry. Authority for sites 2, 3, 4, 6, 7, 8 and 9 will terminate if not activated within five years and authority for site 5 will terminate if not activated within ten years. In addition, authority for site 10 will be terminated if no foreign-status merchandise is admitted for a bona fide customs purpose within three years.

IPR Recordation and Enforcement Forms Under Review by CBP

U.S. Customs and Border Protection is accepting comments through Dec. 21 on the proposed extension without change of information collection requirements concerning the regulations relating to the recordation and enforcement of trademarks and copyrights. Trademark and trade name owners and those claiming copyright protection may submit information to enable CBP to identify violating articles at the borders. In addition, parties seeking to have merchandise excluded from entry must provide proof to CBP of the validity of the rights they seek to protect. 

Applicants Sought for NAFTA Binational Panel Roster

The Office of the U.S. Trade Representative is seeking applications from those interested in being included on a roster of individuals who may be called to serve on NAFTA binational panels that review antidumping and countervailing issues. Applications for membership on this so-called Chapter 19 roster during the period April 1, 2013, through March 31, 2014, should be received no later than Nov. 30.

Article 1904 of NAFTA provides that a party involved in an AD or CV proceeding may obtain review by a binational panel of a final AD or CV determination of one NAFTA party with respect to the products of another. Binational panels decide whether such determinations are in accordance with the domestic laws of the importing party and must use the standard of review that would have been applied by a domestic court of the importing party. A panel may uphold the determination or may remand it to the national administering authority for action consistent with the panel’s decision. Panel decisions may be reviewed in specific circumstances by a three-member extraordinary challenge committee selected from a separate roster of 15 current or former judges.

Chapter 19 roster members must be citizens of a NAFTA country, must be of good character and high standing and repute, and are to be chosen strictly on the basis of their objectivity, reliability, sound judgment and general familiarity with international trade law. Aside from judges, roster members may not be affiliated with any of the three NAFTA countries. 

Applicants Sought for NAFTA Binational Panel Roster

The Office of the U.S. Trade Representative is seeking applications from those interested in being included on a roster of individuals who may be called to serve on NAFTA binational panels that review antidumping and countervailing issues. Applications for membership on this so-called Chapter 19 roster during the period April 1, 2013, through March 31, 2014, should be received no later than Nov. 30.

Article 1904 of NAFTA provides that a party involved in an AD or CV proceeding may obtain review by a binational panel of a final AD or CV determination of one NAFTA party with respect to the products of another. Binational panels decide whether such determinations are in accordance with the domestic laws of the importing party and must use the standard of review that would have been applied by a domestic court of the importing party. A panel may uphold the determination or may remand it to the national administering authority for action consistent with the panel’s decision. Panel decisions may be reviewed in specific circumstances by a three-member extraordinary challenge committee selected from a separate roster of 15 current or former judges.

Chapter 19 roster members must be citizens of a NAFTA country, must be of good character and high standing and repute, and are to be chosen strictly on the basis of their objectivity, reliability, sound judgment and general familiarity with international trade law. Aside from judges, roster members may not be affiliated with any of the three NAFTA countries. 

AD/CV Notice: Honey from Argentina

Agency: International Trade Commission.
Commodity: Honey.
Country: Argentina.
Nature of Notice: Termination of sunset reviews of antidumping and countervailing duty orders in light of their revocation as of Aug. 2, 2012. 

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