Compliance Resources to Help you Stay Current

FDA Import Program: How to Comply with Regulatory Requirements?

U.S. Customs and Border Protection (CBP) and FDA work concurrently during the import entry process and rely on each other’s import requirements to determine the admissibility of a product. The typical import process begins with the CBP service, which collects tariffs that have been placed on imported goods. There are some basic steps that should be considered to start the import process with CBP. Once the import process starts, FDA will be involved as another government agency as it has overlapping jurisdiction over the product.

The Reason Supply Chain Responsibility is a Must

Supply chain management – a term coined in the early ‘80s when globalization and outsourcing spread their wings to seek offshore hubs to reduce costs, and source labor and materials closer to their operational and production setups in emerging economies. While supply chain management found its definitions and parameters, the need for supply chain responsibility came quick at its heels.

Laying Down the Law: Japan’s Message to UK and EU Over Brexit

“There are numerous Japanese businesses operating in Europe, which have created 440, 000 jobs. A considerable number of these firms are concentrated in the UK. Nearly half of Japanese direct investment intended for the EU in 2015 flowed to the UK, and the UK was one of the major destinations for Japan’s investment stock within the EU as of the end of last year.”

                                                                                                                  - Ministry of Foreign Affairs of Japan

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.

This article gives an overview and summary of the International Safe Container Act.

The FDA will soon be implementing a new import screening tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT. This system is expected to improve the current electronic screening system by targeting higher risk products and minimizing delays in shipping lower risk products.

This article gives a brief overview of the PREDICT tool and recent developments in its implementation.

US President Obama recently announced more sanctions against the current Syrian regime led by President Bashar el Assad. Syria has been rocked by anti-government protests and violence for much of 2011.

These new sanctions have been taken pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (IEEPA) and Syria Accountability and Lebanese Sovereignty Restoration Act of 2003 (Public Law 108-175) (SAA).

This article discusses the details of these additional sanctions and how American businesses are expected to comply.
 

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.

This article describes the background to the act, its various titles and provisions.

A Multilateral Export Control Regime (MECR) is an international body that states use to organize their national export control systems. There are currently four regimes: The Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies, The Nuclear Suppliers Group (NSG) for the control of nuclear related technology, The Australia Group (AG) for control of chemical and biological technology that could be weaponized and The Missile Technology Control Regime for the control of rockets and other aerial vehicles capable of delivering weapons of mass destruction.

The U.S Congress passed the Hazardous Materials Transportation Act (HMTA) in 1975 in response to extensive illegal dumping of hazardous material. Its stated purpose is "to provide adequate protection against the risks to life and property inherent in the transportation of hazardous material in commerce by improving the regulatory and enforcement authority of the Secretary of Transportation."

The Industrial Relations Act 1979 seeks to consolidate and amend the law relating to the prevention and resolution of conflict in respect of industrial matters, the mutual rights and duties of employers and employees, the rights and duties of organizations of employers and employees, and for related purposes. It is comprised of seven parts. The important parts of the legislation and what they cover are explained in the following Table:

The Telecommunications Industry Association (TIA) issued a news release officially filing its 2011 1377 Report to the United States Trade Representative (USTR). The USTR is required to report in detail on the compliance, effectiveness, and implementation of U.S. telecommunications trade agreements. This detail requirement comes under Section 1377 of the Omnibus Trade and Competitiveness Act of 1988.

Privacy advocates criticized the U.S. Department of Commerce’s call on self-regulation for the online ad industry and the proposed "safe harbor" from the enforcement actions of the Federal Trade Commission (FTC).

The new report calls for a "Dynamic Privacy Framework" that would revitalize Fair Information Practice Principles (FIPPs). The paper recommends the creation of a Privacy Policy Office within the Commerce Department that would help develop voluntary privacy codes of conduct within a multi-stakeholder negotiation process.

The report drew flak due its shortfalls on the two areas, though some privacy advocates acclaimed the recognition of privacy issues. Many of the concerns surround the enormous gap between consumer privacy expectations and business reality in the online environment, where the general public is subjected to hidden tracking devices that are becoming increasingly sophisticated. The Commerce Department strongly supports greater adherence to the well-known Fair Information Practice Principles.

It also discusses the need to reform the Electronic Communications Privacy (ECPA) Act since cloud computing has drastically risen, and law enforcement agencies are concerned with data stored or traversing by service providers, keeping in line with the goals of the Digital Due Process coalition that the Electronic Frontier Foundation (EFF) is helping to steer.

Digital Due Process coalition

The "Digital Due Process" coalition includes major Internet and telecommunications companies like Google, Microsoft, and AT&T as well as advocacy groups such as the American Civil Liberties Union (ACLU) and the Center for Democracy & Technology (CDT). The coalition has joined together to preserve traditional privacy rights and clarify legal protections in the face of a rapidly changing technological landscape.

Electronic Communications Privacy Act

The Electronic Communications Privacy Act (ECPA) of 1986 was enacted by the United States Congress to extend government restrictions on wire taps from telephone calls to include transmissions of electronic data by computer. The ECPA has come under a cloud of criticism over the years including its failure to protect all communications and consumer records. Under the ECPA, a governmental agency can easily demand consumer data stored on servers from service providers with a written statement certifying that the information is relevant to an investigation of foreign counterintelligence with no judicial review required.
 

Source

http://www.eweek.com/c/a/Security/Commerce-Online-Privacy-Report-Gets-Mixed-Grades-661990/

https://www.eff.org/press/archives/2010/03/30

http://en.wikipedia.org/wiki/Electronic_Communications_Privacy_Act

The onset of technology has helped businesses move to being paperless offices. Availability of real-time information has all the more increased efficiency and control. Financial institutions are able to exercise more control in terms of transactions. This has helped to integrate all the functional partners for the smooth conduct of trade across borders. Transperancy in global trade has increased which has brought to the fore many ineficiencies of the old system.

Global economic sloowdown had its repercussion on all factes of market including trade. Trade pricing have seen downward trend in the last year. Recovery has been slow but experts feel the price will reach a more realistic level based on the demand-supply trend. Onus is on the banks to better understand the nature of business of their clients so as to make a detailed risk assessment and provide needed financial support.