Tag

for

FDA IssuesFoodFSMAImport

June 10 – FSMA Rules Will be Released!

posted by Jennifer Diaz May 22, 2013 0 comments

The U.S. Food and Drug Administration (FDA) has been court ordered to set firm dates for FSMA’s implementation.  Details of the court case forcing FDA to set these dates, and the organization that sued the FDA to make this happen follow.

Background

The Center for Food Safety (CFS), a national non-profit public interest and environmental advocacy organization, filed a lawsuit against the FDA on August 29, 2012.  The complaint alleged FDA failed to promulgate 7 food safety regulations required by the Food Safety Modernization Act (FSMA).  Congress enacted the FSMA – which was signed into law on January 4, 2011 – to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA’s inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. CFS documented the foodborne illness outbreaks since FSMA was signed into law, January 4, 2011.

Court Order

The court case is being heard by Judge Phyllis Hamilton, in the U.S. District Court for the Northern District of California.  Yesterday, May 21, 2013, Judge Hamilton ordered that the FDA and CFS have an extended deadline of June 10, 2013 to file a joint statement with a mutually agreeable proposed schedule for the outstanding food safety rules.

Rationale for Suit and Missed Deadlines

The ongoing battle between the CFS and FDA to complete this process has lasted for several months. On August 2012, the CFS filed a suit against the FDA Commissioner after the FDA missed a series of deadlines for publishing the regulations mandated by the Food Safety Modernization Act. After numerous deadlines went by without the release of the mandated rules, CFS went to court to try to force FDA to adhere to these time constraints. Following the court appearance, Judge Hamilton ruled that the FDA must come up with a new schedule for issuing the proposed rules by May 20.  This extension came about as a result of the inadequacy in time provided for the FDA and CFS to resolve their differences regarding the schedule FDA suggested to issue the proposed rules.

The FDA sent its updated schedule to CFS on May 15; however, CFS was not satisfied with the proposed timeline. Due to the fact that there were only five days left until the deadline expired, the parties filed a Joint Stipulation for Extension of Time. This extension was granted by Judge Hamilton.

New Rules Released by FDA & What’s to Come

Since CFS filed its complaint last year, FDA has released some of the key FSMA mandated rules it failed to publish on time, including preventive controls for human food and standards for produce safety, both released in early January. However, there are some rules that are yet to be released. Among them is the foreign supplier verification program (section 301).  This program is set to overhaul import safety, an establishment of regulations to ensure the safe transport of food products and a rule ensuring neutrality of third-party audits.  I think of it akin to C-TPAT (Customs-Trade Partnership Against Terrorism).  It’s a self policing and auditing type program that includes functions like  monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

I look forward to seeing and reporting on FDA’s implementation of FSMA.

U.S.Customs

Why is U.S. Customs Issuing So Many Requests for Information (CBP Form 28)?

posted by Jennifer Diaz November 7, 2010 2 Comments

WARNING!  U.S. Customs and Border Protection (CBP) has issued a record number of CBP Form 28s (Request for Information) and CBP Form 29s (Notice of Action) so far this year.  Import Specialists of CBP at ports of entry all over the United States are sending out these forms to importers demanding responses.  If the responses are not satisfactory, the CBP officer will demand payment of customs duties. What an importer states in its response to CBP may result in CBP taking no further action, assessing customs duties, issuing a monetary penalty notice, or even referring the case for criminal prosecution. 

A CBP Form 28 is entitled "Request for Information", and it demands that a response be submitted by the importer of record, in writing to CBP, within 30 days of the date of the Request.  The response is typically signed and dated by a company official, usually a corporate officer or manager.  Moreover, the company employee who signs the form certifies that the statements made by the company are true and correct.  The person who signs the CBP form is reminded that false statements on the form to CBP may result in criminal prosecution against that person.

CBP may demand records and assess penalties, demand payment of duties, or take other legal action up to 5 years after an entry of a shipment is made in the United States, according to 19 U.S.C. 1509, 19 U.S.C. 1621, and 19 CFR Part 151.  A Request for Information form may be the first step for CBP to discover violations committed by an importer.  Typically, the CBP officer demands proof that a certain product ((often a textile) qualified for the free trade agreement identified by the importer when it brought the shipment into the United States.  Another typical demand from CBP is an explanation from the importer why a shipment of a certain item from a certain country (often China) should not be subject to anti-dumping duties.  The most common problem remains that CBP believes that an importer failed to declare the proper tariff classification on the imported product, thereby attempting to avoid paying higher customs duties.

Why CBP is now issuing a record number of CBP Form 28s has not been disclosed to the public. Maybe it is the Federal Government’s misguided effort to collect additional revenue, or maybe CBP discovered that importers are not properly declaring shipments as accurately as they did in prior years.  Whatever the reason, importers and customs brokers must be careful when drafting and filing a written response to CBP. 

I am regularly hired by importers or customs brokers only after CBP has taken action against the importer or broker which resulted from not carefully responding to a CBP Form 28.  Rather than getting hired after ‘the horse is out of the barn,’ it sure would be easier for a customs attorney like me to get hired to draft the response to the CBP Request for Information.