All domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the U.S. Food and Drug Administration (FDA), according to the new Food Safety Modernization Act (FSMA). Registering any time between Oct. 1 and Dec. 31 will keep food companies in compliance with FSMA, according to FDA. Renewal registrations are required every two years in even-numbered years. There’s been a registration requirement for food manufacturers under the 2002 Bioterrorism Act since Dec. 12, 2003. The FSMA appears to be casting wider net, however. And now registrations can be cancelled for food safety violations. With FSMA’s start-up regulatory packages held up at the White House, and FDA not doing much talking, some food industry sources are wary about the deadlines that are now approaching. Florida-based ScoringAg, a pision of Scoring System Inc. which offers full-chain traceability and archiving systems for FSMA compliance, decided to fill that vacuum by sending its clients an email newsletter with some tips in question and answer form. A few excerpts: Q. What is a food/feed facility? A. A food facility includes any factory, warehouse (course grain/hay storage, drying or grain cleaning or mixing or conditioning facility) or establishment that manufactures, (mills, or feed grinding/mixing operation) or processes, packs, or holds (bin storage) food or feed. Manufacturing/processing activities include making food (feed or rations) chopping from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food or feed crops or ingredients. On-farm washing, trimming off outer leaves, and cooling produce are considered part of harvesting and would not require classification as a facility if done on the same day as harvesting. If you hold the harvest in a storage/cooler or warehouse you are a facility. Q. Which farms are required to register as food facilities with FDA? A. If you grow it, store it, pack it, ship it. Farms must register as food facilities with the Food and Drug Administration if they manufacture, process, pack, or hold food/feed beyond what is considered harvesting. Farmers might be eligible for exemption under the so-called Tester Amendment, named for the Montana senator who sponsored it. That will depend on how FDA defines direct marketing. And, according to Scoring Systems Inc., there is a long list of activities that will be counted as manufacturing and processing. It’s offering its consultants to help business people with questions as are many others with help the food industry interrupt what’s coming from FDA.

  • Jim

    Real Nice of Scoring Ag to provide such a all-encompassing check list of what constitutes a “facility” in the absence of FSMA rule-making.
    Their interpretation should do wonders for boosting their business…

  • Ben Mark

    Interesting. I wonder why our organizations don’t tell us. I just found out, if we registered already we have to re-register from October 1, 2012 on to get a new FDA Code.

  • Jim,
    The ScoringAg system is comprehensive and cost effective. At an annual cost of $10.00 it is just good business sense.
    Why wait for the FDA to fine you. Reinspect fees are $224 an hour. Can you afford that?

  • husna aijaz

    The following is the full text of the law:

  • Jim

    Pamela (and Dan) —
    Seems that FSN turned an advertisement for Scoring Ad into a news story.
    Farmers need objective information, not self-serving alarmist proclamations such as You Better Register Now…. Why Wait for FDA to Fine You…. etc.etc. The fact is there are many ambiguities right now due to the unfinished/unrealized regulatory process.
    And actually, farmers may be much better served by waiting for actual FDA pronouncements and definitions before thinking — or getting scared into thinking — that they have to sign up as a facility. Unregistering at a later date is a difficult process and FDA assumes your initial self-admission is the real one. Also registration kicks in a whole set of responsibilities, compliances, paperwork and inspections — which contrary to the Scoring Ag scare stories should definitely not be rushed into.
    And finally (Dan) it would be GREAT if FSN actually objectively reported on the actual facts as they are known at this time. What DOES FDA actually say at this point? Where are the inexactnesses and uncertainties in the present language? What are the ramifications? etc.
    Now THAT would be a real story — not just an embellished advertisement….

  • Ben Mark

    I don’t see the links to the registration issue as described in the article in the above link to the full text of the law. Here are links related to the facility registration:
    Link to the registration page:

  • Ted

    What’s that Jimbo — you suggest farmers should NOT be scared? This is a first for you when your NOFA message to everyone has always been; be afraid, be very afraid.
    Lifestyle farmers planning to sell food should get themselves registered right away. Getting “unregistered” (whatever the heck that is) will be far less painful than being prosecuted for evading registration prior to poisoning some innocent family and putting their kids and old folks in the hospital….or worse.

  • Farms must register as food facilities with the Food and Drug Administration IF THEY:
    Manufacture, process, pack, or HOLD FOOD/FEED BEYOND what is considered harvesting, and
    Direct market less than 50% of their product.
    In this instance, direct marketing means direct farmer-to-consumer sales and does not apply – like in other direct marketing specifications in the Act – to stores and restaurants.
    Manufacturing/processing activities include making food/feed from one or more ingredients, or synthesizing, preparing, treating, shelling, drying, modifying, or manipulating food/ crops or ingredients. Examples of manufacturing/processing include: Grains and other foods/feeds
    Cutting, Silage, Hay Processing
    Cooking, Grain Roasting
    Baking, Cotton Ginning
    Cooling, Drying, conditioning
    Pasteurizing, Proponic acid treating grain
    Mixing, Commingling
    Formulating, Hulling
    Bottling, sizing, sorting
    Milling, Mixer/grinder TMR / rolling/ flaking
    Grinding, Nut Hulls,
    Extracting juice, Shelling
    Distilling, DDG’s
    Labeling, or
    On farm washing, trimming of outer leaves of, and cooling produce are considered part of harvesting and would not require classification as a facility if done on the same day as harvesting.

  • Ben Mark

    Jim, I hope you had a chance to educate yourself about the FDA requirements by reading the FDA pages. It is unlikely FDA will send an invitation letter to unregistered facilities and beg them to register now. FSN is doing an excellent job informing their readers what’s going on. There are other news magazines out there, telling their readers the facts and the consequences of not registering: “FDA’s New Registration Powers Include Food Suspension Authority”
    FSMA: [[Page 124 STAT. 3893]] “(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls… FDA recognized these one-day snapshots of some people’s opinion are not going to work. Doesn’t almost every recalled product have some kind of certification? What I see and read: FSMA is all about daily documentation of prevention practices of sanitation. If there is a system on the market as described by Pamela that’s cheap what is to argue about it?

  • Brent

    Jim seems to be advising producers to blow it off, he suggests some food producers can fly undetected beneath the radar. Maybe so right up until they make some people sick or even when some annoyed whistleblower turns them in.
    When you’re introducing food into the system it is only a matter of time until you are scrutinized. Now USDA scrutiny will include a look at your registration documents. That should happen before hearing lame arguments about how you think you qualify for the Tester exemptions. Argue all you like, argue all the way to court. Hell, argue all the way to the bank…this time to withdraw funds to cover the fines.
    Do the smart thing, the responsible thing for once and just get registered. Use your own precautionary principle philosophy of “just label it”, if that helps you get a grip. Just do it — puny claims of ignorance will not grant you any do-overs after you’ve sickened a bunch of kids.

  • Ray Webb

    If someone things they are “Testered” and have a facility for storage, cooling and/or processing they will have to register with FDA as I see it. I don’t read about an exemption for FDA Facility Registration.

  • Meg

    According to the FDA website , the scope of of who is required to register under the act has not changed, so if you are not required to have registered under the previous regulations, you will not be required to register now. I agree with Jim, this is a glorified advertisement! The registration process is fairly quick and easy.
    Pamela, reinspection fees have nothing to do with the registering of facilities. A company will only have to pay those fees if the FDA has to return to your facility and ‘reinspect’. Also if AG charges $10 annually and you only have to register every other year it is kind of a waste of time any money. In the amount of time it takes to provide AG your facility informaiton, you could be registered with the FDA.
    Ben & Brent, you can only re-register between Oct-Dec, so the ‘register now’ is a scare tactic to get you to sign up with the company.

  • Ray Webb

    Meg wrote: According to the FDA website, the scope of of who is required to register under the act has not changed, so if you are not required to have registered under the previous regulations, you will not be required to register now.
    Meg and Jim, you had better have a lawyer read you the new requirements covering a product holding after harvest that you intended to sell into the food or feed chain later on. Guess you did not open all links to the FDA site. The Farm description from FDA has changed if you know. Brent’s comment,that should happen before hearing lame arguments about how you think you qualify for the Tester exemptions.
    BTW I checked with ScoringAg and found out this is a record keeping and traceback system and not a registration page for FDA as assumed by Meg.
    People making comments should be better informed and educated.

  • For everyone’s information the renewal system is still down but the FDA Facility Registration system for new accounts is up and running. This is for the large amount of businesses that never signed up for the FDA Bio-terrorism 2002 law for food defense as it was voluntary at that time. Now this will be every two years.

  • Jeffjward

    This is a malfunctioning government. I have been trying to reregister for the last week. The system would not accept the Account ID No. or password. I called and got put endlessly on hold. Ok. Maybe that was Hurricane Sandy. I finally reached someone at the help number. The FDA had changed my facility ID no. slightly with no notice to me. Then they changed their selected password by one character, again with no notice to me. I finally was able to get into the system and attempted to change my password with no success. We are still not reregistered. Gubnerment at its best.