Archive for the ‘Agriculture’ Category


 

Mandatory Re-registration with FDA Due Dec 31, 2012

As customs brokers for many importers who ship U.S. Food and Drug Administration (FDA) regulated products, Pacific Custom Brokers has been actively monitoring and informing companies of the changes in U.S. FDA regulations.

As a non-domestic food facility importing FDA regulated food products into the United States, your firm is directly affected by the Food Safety Modernization Act (FSMA), which was enacted in January 2011.

 

New Biannual Registration Requirements

The new act requires that all food facilities, foreign and domestic, must re-register with FDA.  This act EXPANDS the registration mandate under the Bioterrorism Act of 2003, to state that all facilities must re-register every two (2) years between October 1 and December 31, beginning in 2012.  The re-registration module of FDA became available on October 22, 2012.

Your current registration will expire on January 1, 2013.  If re-registration is not completed prior to that date, your current registration will be considered invalid and you will be required to register anew.  This will create a new FDA registration number for your facility and all products that you import into the U.S.  In order to complete your re-registration, you will need to have the original FDA facility registration account number, your password, and your PIN.


U. S. Agent Required for Foreign (Non-U.S. Domiciled) Food Facilities

One of the requirements for registration of a foreign (non-U.S. domiciled) food facility is that a U.S. domiciled agent be appointed. The U.S. agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.

Note: When you first registered with FDA, you may have appointed one of your customers, or a custom broker, as your agent.  At the time the Bioterrorism Act took effect in 2003, there were very limited responsibilities placed on the agent.  The FSMA greatly expands these requirements, to include the financial liability of payment to FDA for all re-inspection fees.  Your current agent may not be willing to accept the liabilities involved under the new requirements, and will be given an opportunity to decline that role, which will render your re-registration invalid.

Pacific Customs Brokers can assist you with food facility registration or renewal and U.S. Agent services. Our 24 hour, 7 days a week operation is available to provide immediate answers to your regulatory questions.  Please address your comments and questions to the team at Pacific Customs Brokers at tcg@pcbusa.com or call us at 877-332-8534.

 

Read more on our blog:

Food Modernization Safety Act – Re-Registering your Facility with the FDA

U.S. Food Safety Modernization Act – Does It Affect Me?

Good to Know: FDA Food Facility Re-registration Now Open

 

To stay current on this topic, you may also want to subscribe to Pacific Customs Brokers’ weekly trade newsletter.

 

Do you have questions on the FDA food facility re-registration? Share them in our comments section below.

 

RE-Registering your Food Facility with the FDA

VeggiesIf your firm engages in the manufacture or processing, packing or holding of food, beverages, or dietary supplements for either human or animal consumption, and those goods are destined for the United States, you are required to register with the U. S. Food and Drug Administration.  Foreign facilities must also designate a U.S. agent for FDA communications purposes.

The registration regulations apply to all facilities that handles any of the following:

  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverage – including alcoholic beverages and bottled water
  • Fruits and vegetables
  • Fish and seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Canned and frozen foods
  • Bakery goods, snack food, and candy – including chewing gum
  • Live food animals
  • Animal feeds and pet food

The Food Modernization Safety Act requires that all food facilities that are required to register must renew their registration every other year, beginning in 2012.  The first registration renewal cycle will occur from October 1 to December 31, 2012.  All facilities will be required to re-register every two years thereafter.

We all know how quickly summer wanes and fall comes back around, and October will be here before we know it.  Now might be a good time to review the information submitted on your original FDA registration and to be prepared to make any adjustments or amendments that may be necessary.  While official re-registration will not be accepted until October 2012, the FDA encourages you to review and update your registration information regularly.   To electronically update your facility registration, please visit the FDA web page.

Be aware that there are a number of private firms who are available to handle your registration for a fee, however the above link will take you directly to the FDA site, and there is no charge to register or update or re-register your facility.  This allows you to retain control over the information that is provided to the FDA, and to make necessary updates promptly.

As always, Pacific Customs Brokers is pleased to assist you in answering your questions and discussing how the regulations affect your firm.  We can assist you in understanding your legal options and help cut through the red tape of importing to the United States.

CFIA – New Regulations and Informed Compliance

As an importer, you must keep current with the new and upcoming changes in regulatory requirements for all government departments.   The Canadian Food Inspection Agency (CFIA), for example, with regard to food and plant product imports, will have some changes.   The upcoming changes in regulations include:

The Food Safety Action Plan (FSAP) is a five year initiative that aims to modernize and strengthen Canada’s food safety system and increase collaboration and information sharing among government partners, industry, and consumers in the Imported Food Sector (IFS), as well as provide the Canadian Food Inspection Agency (CFIA) with an enhanced ability to communicate important information to importers to assist in mitigating food safety risks.

Imported Food Sector (IFS) products represent approximately 70% of food products sold in Canada.   An IFS product is any imported food or food ingredient for human consumption.

If you are an importer of IFS products, then becoming prepared for the full implementation of the Food Safety Action Plan (FSAP) is a MUST.   In the next two (2) years, the FSAP regulatory requirements will be enforced and if you are not in full compliance, you will be unable to import IFS products.

New regulations and informed compliance for solid wood packaging materials such as pallets, crates and dunnage.   If you are an importer of machinery or other non-CFIA regulated products, your imports will still fall under the aegis of the CFIA due the packaging materials used.   Are you and your vendors aware of the upcoming changes for all solid wood packaging materials exported from the United States?

To assist importers in becoming aware of the implications and requirements of the upcoming CFIA regulations, Pacific Customs Brokers is hosting a CFIA Seminar on Thursday February 24, 2011.   Carol Brown, LCB, CCS,   the instructor of the CFIA session, will be providing an update on the latest food licensing and wood packaging materials requirements as well as outlining basic documentation and tips to avoiding Administrative Monetary Penalty System fines. We strongly urge all persons involved in the transportation or importing of wood packaging materials and the   importing of food products to attend the CFIA Seminar.

For more information on registering for the CFIA Seminar, please email seminars@pcb.ca or contact Yvette Fox at 888.538.1566.

Are You Importing From Countries with Invasive Pests?

In order to import a product from another country into Canada, you or your customs broker must research the import requirements. Some import requirements may regulate an invasive pest (s) that is in the country of origin or the product being imported. The importance of these requirements is to ensure the safety of Canadian ecology and agriculture.

What is an invasive pest?

An invasive pest is any organism that is not native to Canada, but could make a home for itself to the detriment of any of Canada’s many climatic regions.

Not only are the products that are being imported required to be certified free of the pest in question, the packaging materials must also meet certain treatment standards or they will be refused entry into Canada.

Canada, being such an expansive country, has many different import requirements based on different climatic regions. For example, importing bell peppers from California into British Columbia requires certificates of origin or Phytosanitary Certificates certifying that the peppers are free of Light Brown Apple Moth, whereas importing those same peppers directly into Ontario requires no additional import certificates.

The Canadian Food Inspection Agency (CFIA) has published a comprehensive list of the invasive pests that Canada regulates, which includes: invasive insects, mollucs, virus, fungus, phytoplasma, plants, bacteria, nematodes, mite and unknowns that, after risk assessment, have been found to be a detriment, potential or otherwise, to Canada.  Who knew so many different things could be classified as invasive?

Contained in this list is also the plant protection directives that the CFIA uses to enforce preventative measures for each pest.  When using the CFIA Automated Import Reference System (AIRS) tool to check for import restrictions by commodity, it will also link back to each directive, but by commodity versus by pest.  Some commodities are regulated for more than one (1) pest and therefore are covered by more than one (1) directive. These directives also outline the preventative methods and documents required for importing regulated commodities.

If an invasive pest is found in the commodity or its packaging, the shipment could:

1) be refused entry;

2) require treatment before export; or

3) be destroyed.

Takeaway: Before you import, check for import regulations.  By acquiring the knowledge of which commodities are regulated and their import requirement, it will assist you in avoiding unforeseen consequences.

U.S. and Canadian Wood Packaging Materials – Informed Compliance Enforcement

In 2005, Canada and the United States implemented, but did not enforce, wood packaging materials movement requirements.   Since that time, all U.S. and Canadian manufactured wood packaging materials, such as pallets, crates, dunnage etc., have been able to move freely through the shared border of both countries without having to prove pest control treatment methods used on the wood packaging materials.

Recently, both the United States and Canada have concluded pest-risk studies associated with the movement of wood packaging materials with the decision that several pest and logistical issues can be negated by requiring all wood packaging material moving between the two countries meet International Standards for Phytosanitary Measures No. 15 (ISPM 15) (2009) regulations.

ISPM 15 is the International Phytosanitary Measure developed by the International Plant Protection Convention (IPPC). It directly addresses the need to treat wood materials of a thickness greater than 6mm used to transport products between countries. Its main purpose is to prevent the international transport and spread of disease and insects that could negatively affect plants or ecosystems. ISPM 15 affects all wood packaging material (pallets, crates, dunnages, etc.) and requires that they be debarked, then heat treated or fumigated with methyl bromide, and then stamped or branded with a mark of compliance.   Products exempt from the ISPM 15 are made from alternative material, such as paper, plastic or wood panel products (i.e. OSB, hardboard, and plywood).

Both countries understand the potential financial and logistical impacts of these new regulations on Importers, Exporters and Producers of wood packaging materials, and to that end are working on creating and clarifying their directives (Canadian Food Inspections Agency) and rules (United States government) regarding the movement of wood packaging materials. Both countries are currently in discussion regarding the issuance of a fair harmonized approach to enforcement starting with a period of “informed compliance” starting in Spring 2011 moving towards full compliance in the Summer of 2012.

During the period of “informed compliance”, wood packaging materials found or suspected to be in non-compliance with the new wood packaging regulations would be allowed to move to the destination and the carrier will be notified of the ISPM 15 requirement. However, if pests are found then the Importer may be required to treat the non-complaint materials to prevent the spread of the pests, and/or the shipment may be refused entry.   Once full enforcement comes into affect, all non-compliant wood packaging materials will be refused entry by the destination country and, should pests be detected, may require the shipment be treated, at the cost of the importer, prior to returning the shipment to the exporting country.

Suggestions From Your Broker Knows:

If you are a Producer of wood packaging materials:   Research your options on how to become registered as an ISPM 15 (2009) compliant producer, if you are not already.

If you are an Importer or Exporter:  Communicate with any party that is involved in the transportation of your imports to ensure that they are aware of the upcoming changes and are working on the transition to acceptable wood packaging materials.

If you are a transportation company:   Keep abreast of the up coming changes so that you can communicate them to your clients in order to not have your trucks delayed, and ensure that you only agree to transport ISPM 15 compliant wood packaging materials.

The memorandum regarding these regulations from the Canadian Food Inspection Agency Forestry Division, Plant Health and Biosecurity directorate can be found here.