KEEPING MARKETS OPEN: SUCCESSES IN REDUCING TECHNICAL BARRIERS TO AMERICAN EXPORTS
A new USTR report on key technical barriers that American exporters face includes information about USTR's 2009 successes in breaking down these barriers around the world. Key USTR progress in breaking down technical barriers to trade includes:
CHINA: INTERNET FILTERING SOFTWARE AND MEDICAL DEVICES
Internet Filtering Software: In May 2009, China's Ministry of Industry and Information Technology proposed a measure that would have required imported and domestically-produced computers sold in China to be pre-installed or packaged with a Chinese-produced internet filtering software program called Green Dam. The requirement would have gone into effect in July 2009, leaving only two months for compliance by U.S. companies. U.S. officials, as well as a broad coalition of global industry groups and other countries, expressed serious concerns about this proposed measure and urged China to revoke it. In June 2009, China announced that it was suspending the measure indefinitely.
Medical Device Regulations: The United States has expressed a number of concerns with China's regulatory regime for medical devices. First, China maintains two separate authorities -- the State Food and Drug Administration (SFDA) and the State Authority of Quality Supervision, Inspection and Quarantine (AQSIQ) -- to enforce regulations with similar, but not identical, requirements for medical devices. This overlap results in redundant regulatory procedures with no apparent public health benefit. For example, in April 2009, AQSIQ circulated draft Regulations on the Recall of Defective Products at the same time that the Ministry of Health and SFDA were in the process of developing recall procedures.
Second, in April 2009, SFDA proposed a measure to require all medical devices to be registered in the country of export or in the manufacturer's legal residence before they would be accepted for registration in China. This requirement had the potential to block, or inordinately delay, sales of safe, high-quality medical devices to the Chinese market, as manufacturers may decide, for reasons unconnected with the quality or safety of their products, not to seek to have their devices approved in the countries in which they are produced or in the producers' home countries.
In October 2009, China announced that the Ministry of Health and SFDA would serve as the sole regulatory authorities for medical device recalls, and that SFDA would not implement the home-country registration requirement.
ECUADOR: CONFORMITY ASSESSMENT
On November 25, 2008, Ecuador's National Quality Council adopted resolutions that would have required importers of a number of specific products (e.g., safety glass, transformers, ceramic and porcelain house wares and tableware, white goods and appliances, auto parts, cement, plastic, steel and aluminum products, matches, batteries, and lubricants) to demonstrate that they conformed to new Ecuadorian product requirements by providing a certificate of conformity from an accredited certification body. Because Ecuador did not publish these resolutions and notify them to the WTO before adopting them, interested parties had no opportunity to submit comments on them, importers were unable to comply with the new requirements, and some U.S. manufactured goods subject to the new requirements were held at the border.
The United States raised concerns regarding this measure, including its lack of transparency and the difficulties the new certification requirement had caused for many U.S. exporters, in particular that they were finding it difficult to identify test laboratories accredited to test many of the products subject to Ecuador's new requirements. Ecuador rescinded the new resolutions in early 2009 and notified the rescission to the WTO.
INDIA: FOOD AND DISTILLED SPIRITS NUTRITIONAL LABELING
In January 2009, India's Ministry of Health proposed amendments to its nutritional labeling requirements that would have required producers of proprietary foods to list their products' formulations on the label. The United States and other trading partners raised concerns.
In February 2009, India eliminated the requirement that producers include product formulations on the label. The Ministry of Health also indicated that it would exempt producers of distilled spirits from the requirements to include nutritional information and expiration dates on labels. The revised measure entered into force in June 2009, after India provided a three-month delay in enforcement at the request of the United States and other stakeholders. The United States continues to raise concerns regarding other provisions of the Ministry of Health's changes to its nutritional labeling requirements.
KOREA: TESTING REQUIREMENTS
Lithium ion batteries: U.S. consumer electronics producers expressed concerns about Korean measures that required lithium ion batteries used in electronics products such as laptops and cell phones to be tested at one of four Korean laboratories. U.S. industry expressed concern that this requirement would lead to bottlenecks and delays for U.S. exports to Korea. U.S. officials raised this issue with Korea and, in September 2009, Korea published final measures that will allow non-Korean laboratories to test lithium-ion batteries for conformity with Korean safety requirements.
