With minor exceptions, if you are a petfood, treat, chew or nutritional supplement manufacturer, domestic or foreign, now is the time to renew your food facility registration with the US Food and Drug Administration (FDA). Even if you first registered less than two years ago, or recently updated your information with FDA, action on your part is still required. Failure to renew as mandated by law could have serious regulatory consequences. So, even though your product is actually manufactured or distributed by a third party, it may be prudent to remind your co-packer and/or holder of your goods of this requirement as well.
The Bioterrorism Act of 2002 established the requirement that, except for the private residences of individuals (e.g., a pet treat manufacturer working out of a home kitchen), each domestic or foreign facility that manufactures, processes, packs or holds food, as defined in 21 CFR 1.227, for human or animal consumption in the US must register with FDA. If you have multiple facilities, each must be registered separately. When the Act was first enacted, it was intended as a one shot deal; i.e., you registered, then you were in compliance in perpetuity. However, one outcome of the Food Safety Modernization Act (FSMA) of 2011 was to convert registration to a biennial event. Now, every even-numbered year, facilities must renew their registrations.
The registration period this year is between October 1, 2014 and December 31, 2014. If not registered by 11:59 p.m. (I assume it would be Eastern Standard Time, though FDA doesn't specify) of the last day, the registration will be considered expired and will be removed from your account. While not absolutely mandated at this time, the vastly preferred method of registration is online (those who do not have "reasonable access" to the Internet alternatively may submit applications by paper, fax or CD-ROM, although FDA warns of inefficiencies and potential delays by these methods). Hopefully, there are no bugs in the system akin to the healthcare insurance signup problems experienced by many last year. Regardless, FDA "encourages" registrants to access the site early in the renewal period.
I recall an FDA official once describing the process of facility registration as "easier than doing your taxes." I don't know about you, but my accountant makes a good living trying to figure mine out! Fortunately, FDA indicates that for purposes of renewal, an abbreviated process will be made available for those who do not have any changes in information.
Still, it would be prudent to have the following information on hand before going to the site, even if just to confirm that the correct information is in the system.
- Facility name, address, phone number and emergency contact phone number
- Parent company name, address and phone number (if applicable)
- Name, address and phone number of the owner, operator or agent in charge
- Email address for the contact person of the facility or, in case of a foreign facility, the US agent for the facility
- All trade names the facility uses
- Applicable food product categories, as listed on the registration form
- Name, address and phone number of a foreign facility’s US agent, and phone number of the facility’s emergency contact if it is someone other than the US agent
- Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
- Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so
- Facility fax number
- Preferred mailing address, if different from that of the facility
- Fax number and email address of the owner, operator or agent in charge of the facility
- Fax number and email address of the parent company (if applicable)
- For a foreign facility: the fax number of its US agent
- Type of activity conducted at the facility (e.g., processing, packing, etc.)
- Type of storage (if it's a holding facility)
- Approximate dates of operation (if the facility's business is seasonal)
FDA emphasizes the necessity to denote the food product categories applicable to a facility. For petfoods, possible categories include "Pet Food," "Pet Treats or Pet Chews" and "Pet Nutritional Supplements (e.g., vitamins, minerals)." While some of these categories may have been optional fields in previous versions of the registration form, they are now mandatory.