April 11 - Issue 59   

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Radiation from Japan

The following is from CBP's Cargo Systems Messaging Service (CSMS) Message #11-000071 dated 03/23/2011:

On March 22, 2011, FDA issued Import Alert 99-33, "Detention Without Physical Examination of Products from Japan due to Radionuclide Contamination."

Import Alert 99-33 indicates detention without physical examination (DWPE) for the specific food products of concern listed in the Import Alert that have originated from the prefectures of Fukushima, Gunma, Ibaraki, and Tochigi in Japan.

On March, 21, 2011 the government of Japan, in concert with the governments of the affected prefectures of Fukushima, Gunman, Ibaraki, and Tochigi, has stopped milk, spinach and kakina (a local Japanese vegetable) from those prefectures from being marketed either domestically or for export.

Detained products covered by the Import Alert may be released after detention by either providing evidence that:
  1. The products do not originate from the prefectures of Fukushima, Gunma, Ibaraki, and Tochigi in Japan; or
  2. The products do not contain violative levels of radionuclide contamination, by means of laboratory analysis.

Additionally, the importing community should be aware that the FDA has increased its surveillance of all products from the affected prefectures of Fukushima, Gunman, Ibaraki, and Tochigi; and has increased its surveillance of products from other areas of Japan. Importers can expect FDA to conduct many more document reviews for Japanese shipments and can expect examinations and sample collections at a much higher rate than usual. FDA Districts may be asking for additional information related to regions where products originate and to the date of shipment from that region.

Importers are advised that it may speed FDA's review process if entry documentation is provided in a timely manner and, for those shipments indicated for examination or sampling, if location and availability information is provided in a timely manner.

As indicated in the Import Alert, FDA and the Japanese government will continue to collaborate to ensure products from the affected prefectures do not pose a health risk to U.S. consumers. FDA will continue monitoring the potential for public health risks due to possible radionuclide contamination and, when appropriate, will remove the Import Alert and resume routine coverage of entries.

The FDA alert can be found at the following link:
http://www.accessdata.fda.gov/cms_ia/importalert_621.html

FDA will also be updating its "Radiation Safety" webpage: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm247403.htm

Implementation of Indian Customs EDI System v1.5

Per Public Notice No. 29/2011 from the Office of the Commissioner of Customs (Import) at Jawaharlal Nehru Custom House, Nhava Sheva (Mumbai), EDI operations at the Nhava Sheva Custom House will be switching over to an enhanced/modified software version, ICES 1.5. This software upgrade will result in a shutdown of customs system from April 1, 2011 to April 5, 2011. Local filers have been advised that the shutdown could continue for an additional day or two beyond April 5.

Link to the Public Notice No. 29/2011:
http://www.jawaharcustoms.gov.in/newsite/PublicNotices/pn2011/PN-29-11.htm

Food Safety Modernization Act, some basics

The Food Safety Modernization Act was signed into Law by President Obama on January 4, 2011.
  • Issuing recalls: For the first time, the FDA will have the authority to order a recall of food products. Up to now, with the exception of infant formula, the organization has had to rely on food manufacturers and distributors to voluntarily recall food.
  • Conducting inspections: The law calls for more frequent inspections and for those inspections to be based on risk. Foods and facilities that pose a greater risk to food safety will receive the most attention.
  • Preventing problems: Food facilities must have a written plan that spells out the possible problems that could affect the safety of their products. The plan would outline steps that the facility would take to help prevent those problems from occurring.
  • Focusing on science and risk: The law establishes science-based standards for the safe production and harvesting of fruits and vegetables. This is an important step forward. These standards will consider both natural and man-made risks to the safety of fresh produce.
  • Respecting the role of small businesses and farms: The law also provides some flexibility, such as exemptions from the produce safety standards for small farms that sell directly to consumers at a roadside stand or farmer's market as well as through a community supported agriculture program (CSA).
  • Importing food: The law provides significant enhancements to FDA's ability to oversee food produced in foreign countries and imported into the United States. Also, FDA has the authority to prevent a food from entering this country if the facility has refused U.S. inspection.

    Importing food enhancements:

    • Among the improvements is the requirement that importers verify the safety of food from their suppliers and the authority for the FDA to block foods from facilities or countries that refuse our inspection.
    • The FDA will also be working more closely with foreign governments and increasing its inspection of foreign food facilities.
    • The FDA's new import tool kit will have a huge impact on food safety given that an estimated 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.
    • Calls for the strengthening of existing collaboration among all food safety agencies whether they are Federal, state, local, territorial, tribal, or foreign. Among other provisions, the legislation directs the Secretary of Health and Human Services to improve training of state, local, territorial and tribal food safety officials and authorizes grants for training, conducting inspections, building capacity of labs and food safety programs and other food safety activities.


FDA letter to industry contains guidance on medical device imports

Due to concerns that an increasing number of imported medical devices lack sufficient entry data to allow a prompt admissibility decision to be made by United States Food and Drug Administration (FDA) personnel at the port of entry into the US, FDA's Center for Devices and Radiological Health (CDRH), has provided a Letter to Industry containing specific recommendations to facilitate the import entry review process. The submission of correct and accurate entry data and AofC codes will help expedite the entry review process and increase the likelihood that your shipment may be processed based on import system screening and that it is not held for further FDA entry review.

When an imported product arrives in the US, certain information must be provided/ transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by FDA, CBP sends the import entry information to FDA for verification to ensure that the product meets FDA requirements. Without the proper information, FDA may initiate a manual review of each line of the entry, which may lead to delays in its release to the importer/consignee. The FDA is attempting to help expedite the admissibility process for submissions that contain the correct Affirmations of Compliance (AofC) and other requested data.

Consistent and accurate supporting data also impacts radiation-emitting medical electronic products, such as medical lasers, diagnostic x-ray systems, etc. A second letter will be issued describing the import entry filing process for products subject to both the medical device and electronic product radiation regulations.

If you have any questions about the import entry review process for medical devices or any general questions regarding the entry screening process, please contact the CDRH Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov. If you have questions related to a specific detained entry, you must first contact the Import Compliance Officer in your local FDA District Office and reference the entry number for assistance.

The Letter to Industry can be found by visiting the following link:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm

Update on renewal of General System of Preferences (GSP)

As reported in last month's issue of the AIT eNewsletter, GSP is currently suspended because of a hold placed on the bill by Senator Jeff Sessions and Senator Mitch McConnell who have constituents with conflicting interests in GSP. (Senator Sessions has a sleeping bag manufacturer in his district which employs 22 people who are adversely affected by the GSP benefits given to sleeping bags from Bangladesh and Senator McConnell has a constituent company who imports sleeping bags from Bangladesh who benefits from GSP). The problem is that all other importers who benefit from GSP are negatively impacted.

It has been suggested that interested parties should contact each of their senators. A good way to initiate that conversation would be through the following website, which brings together importers who have been negatively affected by the expiration of GSP benefits: http://renewgsptoday.com/

BIS claims broader authority to revise, suspend and revoke export licenses

The Bureau of Industry and Security has issued a final rule clarifying its authority to revise, suspend and revoke export licenses. Effective March 2, this rule amends the Export Administration Regulations to indicate that BIS has the authority to take such action not only whenever it is known that the EAR have been violated or that a violation is about to occur but also to prevent licensed export transactions in which the U.S. may subsequently have an interest, including a foreign policy interest.

Copy of the Final Rule:
Text: http://www.gpo.gov/fdsys/pkg/FR-2011-03-07/html/2011-5079.htm
Pdf: http://www.gpo.gov/fdsys/pkg/FR-2011-03-07/pdf/2011-5079.pdf

Consumer Product Safety Commission introduces information database: SaferProducts.gov

Since March 11, consumers have been encouraged by the U. S. Consumer Product Safety Commission (CPSC) to visit www.SaferProducts.gov to submit Reports of harm or risks of harm, and to search for safety information on products they own or may be considering buying. This database is mandated by Congress, as part of the Consumer Product Safety Improvement Act.

Reporting product safety incidents through this new site will help CPSC identify product hazards quicker and provide consumers with safety information on products in and around the home.

The full press release can be found at:
http://www.cpsc.gov/CPSCPUB/PREREL/prhtml11/11168.html

A recalls database is also available for search:
http://www.cpsc.gov/cpscpub/prerel/api.html


If you have any questions or comments regarding the Compliance eNewsletter,
please contact Paul Codere from the Customs Brokerage Department.
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