Compliance Regulations and Guidance Affecting your Industry

FDA’s Good Importer Practices Guidance: What You Need to Know?

The U.S. FDA, among other several government agencies such as USDA, EPA, U.S. Department of Homeland Security, Customs and Border Protection etc., published a draft guidance on Good Importer Practices (GIP) in 2009. This draft guidance offers general suggestions to the importers on procedures and practices they should follow to ensure that products they import are in compliance with the U.S. safety and security requirements.

Regulations governing the trade of Electrical and Electronic goods between New Zealand and China.

The International Safe Container Act, Chapter 805 of Title 46 of the CFR, details the requirements for application and compliance with the International Convention for Safe Containers signed in 1972 in Geneva. The Act also gives the requirements for approval, examination and enforcement of these requirements. It also contains whistleblower protections. It was enacted into law in 1977.

The Security and Accountability For Every Port Act or SAFE Port Act of 2006 was passed by the United States Congress on September 30, 2006 and President Bush signed the Act into law on October 13, 2006. While the majority of the Act covers the security of US ports, titles VI to VIII provide new requirements in the areas of emergency response to disasters, trucking security, trade of precursor chemicals and internet gambling regulations.

Unfair or deceptive acts or practices.

In connection with the sale of offering for sale by retail food stores of food, grocery products or other merchandise to consumers in or
affecting commerce as ``commerce'' is defined in section 4 of the Federal Trade Commission Act, 15 U.S.C. 44, it is an unfair or deceptive act or practice in violation of section 5(a)(1) of the Federal Trade Commission Act, 15 U.S.C. 45(a)(1), to offer any such products for sale at a stated price, by means of an advertisement disseminated in an area served by any stores which are covered by the advertisement, if those stores do not have the advertised products in stock and readily available to customers during the effective period of the advertisement, unless the advertisement clearly and adequately discloses that supplies of the advertised products are limited or the advertised products are available only at some outlets.
 

No violation of Sec. 424.1 shall be found if:
    (a) The advertised products were ordered in adequate time for delivery in quantities sufficient to meet reasonably anticipated demand;
    (b) The food retailer offers a ``raincheck'' for the advertised products;
    (c) The food retailer offers at the advertised price or at a comparable price reduction a similar product that is at least comparable
in value to the advertised product; or
    (d) The food retailer offers other compensation at least equal to the advertised value.
 

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Passed by the United States Congress in 1976, the Toxic Substances Control Act (TSCA) is a United States law regulating the introduction of new or already existing chemicals. The Act does not part chemicals into categories of "toxic" and "non-toxic". Rather it prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory.

Under 19 U.S.C. §1484, the importer is responsible for using reasonable care to enter, classify and value imported merchandise, and provide any other information necessary to enable Customs to properly assess duties, collect accurate statistics and determine whether any other applicable legal requirements, if any, have been met. 
 

This rule amends the Export Administration Regulations (EAR) by adding additional persons to the Entity List (Supplement No. 4 to Part 744) on the basis of Section 744.11 of the EAR. These persons that are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. This rule also amends one entry by adding an additional address for this person listed on the Entity List. The Entity List provides notice to the public that certain exports, reexports, and transfers (in-country) to parties identified on the Entity List require a license from the Bureau of Industry and Security (BIS) and that availability of license exceptions in such transactions is limited

Effective Date: This rule is effective January 13,2010

In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to add an entity to the list of validated end-users for the People’s Republic of China (PRC) approved to receive exports, reexports and transfers of certain items under Authorization Validated End-User (VEU). Specifically, this rule amends the EAR to add one additional validated end-user and identifies eligible items for export and reexport and transfer (in-country) to one facility in the PRC. In a final rule published in the Federal Register on June 19, 2007, BIS revised and clarified U.S. export control policy for the PRC, establishing Authorization VEU and identifying the PRC as the initial eligible destination

Effective Date: This rule is effective January 15,2010

This rule amends the Export Administration Regulations (EAR or Regulations) by revising an existing license exception to provide a new authorization for exports and reexports of certain commodities subject to the EAR when those commodities are intended for use on the International Space Station (ISS). This rule establishes specific terms and conditions with which exports or reexports must comply in order to take advantage of the new authorization. For example, an export or reexport undertaken in accordance with the new authorization must be consigned to an eligible recipient involved in the launch of the commodity to the ISS. This new authorization is limited to commodities that are subject to the EAR that are needed at a launch destination outside the United States on short notice. This rule defines ‘short notice’ as a requirement to have a commodity manifested and at the scheduled launch site for hatch-closure (final stowage) no more than forty-five (45) days from the time the exporter or reexporter received complete documentation. ‘Complete documentation’ means the exporter or reexporter received the technical description of the commodity and purpose for use of the commodity on the ISS. This rule defines ‘hatch-closure (final stowage)’ as the final date specified by a launch provider by which items must be at a specified location in a launch country in order to be included on a mission to the ISS. BIS has determined there is a low risk of diversion and a high benefit for authorizing these types of transactions to proceed under a license exception

Effective Date: This rule is effective February 9,2010

This rule amends the Export Administration Regulations (EAR) by adding ten additional persons located in Hong Kong and Taiwan to the Entity List (Supplement No. 4 to Part 744) on the basis of Section 744.11 of the EAR. These persons that are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. The Entity List provides notice to the public that certain exports, reexports, and transfers (in-country) to parties identified on the Entity List require a license from the Bureau of Industry and Security (BIS) and that availability of license exceptions in such transactions is limited.

Effective Date: This rule is effective February 19,2010

The Bureau of Industry and Security (BIS) is publishing this final rule to amend the Export Administration Regulations (EAR) by revising the controls on certain select agents identified in Export Control Classification Number (ECCN) 1C360 on the Commerce Control List (CCL) to reflect changes that the Animal Plant and Health Inspection Service (APHIS), U.S. Department of Agriculture, recently made to the Plant Protection and Quarantine Programs (PPQ) list of select agents and toxins. The changes made by APHIS were part of a biennial review and republication of the select agents and toxins lists separately maintained by APHIS and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS). Both agencies maintain controls on the ‘‘possession, use, and transfer within the United States’’ of certain select agents and toxins, including human and zoonotic pathogens, animal pathogens, and plant pathogens. BIS maintains controls on ‘‘exports’’ of the select agents and toxins regulated by CDC and APHIS. CDC and APHIS simultaneously published the revisions to their lists of select agents and toxins on October 16, 2008. These changes became effective on November 17, 2008. BIS determined that the only changes that required amendments to the EAR were the changes to the PPQ list of select agents and toxins maintained by APHIS. This rule also amends ECCN 1E998 on the CCL to remove controls on technology for the ‘‘development’’ or ‘‘production’’ of materials controlled by ECCN 1C995. This technology was inadvertently included in ECCN 1E998 by a final rule published by BIS in September 2006 and was made subject to the anti-terrorism (AT) license requirements described therein. Effective with the publication of this final rule, this technology is once again classified as EAR99.

Effective Date: This rule is effective February 22,2010

In response to the Government of Burma’s continued repression of the democratic opposition in Burma, and consistent with Executive Order 13310 of July 28, 2003 and Executive Order 13448 of October 18, 2007, this final rule amends the Export Administration Regulations (EAR) to move Burma into more restrictive country groupings and impose a license requirement for exports, reexports or transfers of most items subject to the EAR to persons listed in or designated pursuant to Executive Orders 13310 and 13448.

Effective Date:This rule is effective October 24, 2007.

This rule imposes a license requirement for certain exports and reexports of military commodities manufactured outside the United States that are not subject to the International Traffic in Arms Regulations, regardless of the level of U.S. origin content, if those military commodities incorporate certain thermal imaging cameras that are subject to the Export Administration Regulations. This rule also removes Commerce Control List (CCL) based export and reexport license requirements with respect to 36 destinations for certain thermal imaging cameras when they are not incorporated into military commodities and if they are not being exported or reexported to be embedded in a civil product. It imposes a semi-annual reporting requirement on the transactions from which it removes the CCL based license requirements. This rule limits use of License Exception APR for reexports of certain cameras controlled by Export Control Classification Number 6A003.b.4.b and certain foreign made military commodities incorporating such cameras. This rule imposes a license requirement for software used to increase the frame rate of certain cameras. BIS is making these changes in recognition of the emerging availability of these cameras around the world, the export licensing practices of other governments and the potential use of these cameras in military applications

Effective Date:This rule is effective May 22, 2009.

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to establish export licensing requirements for Kosovo.

Effective Date:This rule is effective September 2, 2008.