Month: October 2012

FDA Biennial Food Facility Registration now AVAILABLE!

All food facilities (foreign and domestic) who have previously registered their facilities with FDA must now re-register. Under the Food Safety & Modernization Act of 2011, food facilities are now required to re-register every two years (from October 1 through December 31 of each even-numbered year). Previously registered facilities can now begin re-registering via FDA’s Food Facility Registration website. Please make sure to click the link for “Biennial Registration.”

Failure to register may result in the suspension of FDA Food Facility Registration which may ultimately lead to the FDA holds on imported goods. Domestic importers should inform their overseas suppliers to re-register ASAP.

One word of caution to importers who are asked by their overseas suppliers to act as a U.S. Agent. Don’t do it, unless you are ready to face the consequences. I know in the past that many importers have been willing to help foreign facilities by acting as their U.S. agent. Under the FSMA, the U.S. Agent is liable for FDA foreign re-inspection fees. The posted/suggested rate of of inspection for foreign facilities is currently set at $289/hour. I doubt most importers would be willing to accept this type of liability.

Let me know if you have any questions.

Jimmy Ting

jimmyting@great-world.com

 

 

Medical Device Excise Tax

A part of Obama’s Affordable Care Act included a 2.3% excise tax on medical devices. I had one importer inquire about the excise tax today and the method for paying it. Unlike the Federal excise tax on alcohol, this tax is not collected via U.S. Customs at the time of import. It will be reported on Form 720, the Federal Quarterly Excise Tax Return form.  The IRS has posted an FAQ website to answer some questions that medical device manufacturers and importers may have about the tax.

Here are some other key details about the Medical Device Excise Tax:

  • It is a 2.3% tax on revenue, not profit.
  • Medical devices purchased at retail for individual use are to be exempted. Examples include eyeglasses and hearing aids.
  • The start date is the beginning of the new year, January 1, 2013.

Politicians are working on repealing this excise tax. With only three months left until the new year, manufacturers and importers should be consulting with their CPA and various accounting advisers to discuss which items will be affected by the tax.

-Jimmy Ting

jimmyting@great-world.com

Another Antidumping & Countervailing Duty Investigation: Hardwood Plywood from China

It seems like a month can’t by without another AD and/or CVD case being brought against a product coming from China. The latest product is “hardwood plywood.” If this product sounds familiar, you may be getting it mixed up with the AD/CVD case that was opened last year.

Some interesting facts about this investigation:

  • This case against hardwood plywood was brought by a collection of U.S. manufacturers, The Coalition for Fair Trade of Hardwood Plywood. They claim to represent about 80% of the domestic plywood market.
  • They are represented by the same counsel, Jeff Levin, that let the establishment of AD and CVD duties on engineered wood flooring.
  • They are alleging dumping upwards of 300%.

You can find a timeline for the investigation on hardwood plywood from China at the following ITA website: http://www.usitc.gov/trade_remedy/731_ad_701_cvd/investigations/2012/hardwood_plywood/prelimphase.htm

Let me know if you have any questions.

-Jimmy Ting

jimmyting@great-world.com

Changes to Food Facility Registration under FSMA

Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed by President Obama on January 4, 2011. I have listed out the major changes below:

1.)    Frequency – every two years. In the past, food facilities only need register once. Under the FSMA, food facilities must re-register every two years.

2.)    Start date: The official start date was October 1, 2012. However FDA has delayed the start of re-registration until further notice (http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm?source=govdelivery). Importers should continue to watch out for when the start date opens up.

3.)    Requirement of food facilities to indicate secondary products produced (in addition to the primary product produced).

4.)    “Voluntary” additional information – FDA will be sending out a separate form after the registration is complete. This separate form will ask for “voluntary” information that will be used to determine if the facility is “high risk.” It would seem obvious that it would be in the facility’s best interests to complete the form. However importers should be very careful when completing this form. It will ask for specific information about potential hazards the preventive control measures that the facility is taking.

5.) Re-Inspection Fee: FDA will have the right to inspect food facilities. The part that importers should be aware of is that FDA will be authorized to charge a “re-inspection” fee if a re-inspection is required. For domestic food facilities, the cost of the re-inspection will be born by the domestic facility. However for foreign facilities, the U.S. agent listed on the Food Facility Registration will be responsible for the costs related to the re-inspection.

More information about Registration can be found at the following FDA website: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm

Registration should be be made via the following FDA website: http://www.access.fda.gov/

There is no fee for FDA Food Facility Registration.

Feel free to contact me with questions.

-Jimmy Ting

jimmyting@great-world.com