FDA Registrations revisited

[DaveB]

Last year and earlier this year there were a couple of discussion threads about registering with the FDA. I know many registered, including myself but now I'm a little annoyed. I registered because it was supposed to be benign but the other day I received a call and an email from someone at the FDA in Rhode Island stating that they may need to inspect my operation. Has anyone else heard from them?

Apparently they have an inspection database that was populated with my information. I have no idea how/why because I was under the impression that maple syrup was not an high risk commodity. I'm trying to clear this up and see what the next steps are but I also wanted to see if others were receiving this attention as well.

[maple flats]

As I understand it, some have been inspected. One of my maple equipment dealers was inspected. They were told they had to finish the inside wall and ceiling surfaces (no open studs or joists) and that the concrete floor needed 2 coats of sealer. I don't know of any other requirements. They are the only one I've talked with who was inspected.

[DaveB]

As I understand it, some have been inspected. One of my maple equipment dealers was inspected. They were told they had to finish the inside wall and ceiling surfaces (no open studs or joists) and that the concrete floor needed 2 coats of sealer. I don't know of any other requirements. They are the only one I've talked with who was inspected.

If that's the case, I wonder how many sugar houses would pass inspection? I have a post and beam structure with unfinished plywood walls and ceilings like many sugar houses. I also have a wood floor with cement pad for the arch.

The inspection almost sounds like a health department inspection and I've never had to under go that. I wonder why every sugar house that registered isn't being contacted. I'll let everyone know what happens in case it's coming their way. Someone posted that maple syrup was being exempted but I guess that is not the case.

[GeneralStark]

As I understand it, some have been inspected. One of my maple equipment dealers was inspected. They were told they had to finish the inside wall and ceiling surfaces (no open studs or joists) and that the concrete floor needed 2 coats of sealer. I don't know of any other requirements. They are the only one I've talked with who was inspected.

Is this individual you are referring to a bulk producer selling to a packer?

[GeneralStark]

Just found this on the other site. I guess it was going around amongst the Maine Sugarmaker's Association. This comes direct from a FDA Compliance Officer

"Sugarhouse are not considered a “farm” because you harvest sap from the trees and process the sap into maple sugar. Because of this you are considered a “manufacturer” of maple syrup. Under the FSMA registration guidelines you are exempt from registration because your retail sales (direct to the consumer) exceed your wholesale sales. In contrast, if you were to manufacturer your syrup primarily for wholesale sales i.e. (Hannaford, Stop and Shop, etc.) and those sales are greater than 50% than you would be required to register under FSMA. Bulk producers fall into this category too, and must register with the FDA. Located on the MMPA website, is a link to the website, where you may digitally register online. Lori also recommended that people should contact her directly to explain individual circumstance and get specific questions answered. Her contact information is:



Lori A. Holmquist/Director Investigations Branch/New England District Office/Augusta, ME Phone: 781.587.7437 FAX: 207.622.8273 Blackberry: 207.465.6221"

[DaveB]

I just spoke with the man from the FDA and I think I am OK for the moment. I deliberately had him lead the conversation and answered his questions succinctly (just yes & no). He said they have two databases - one for registrations and one for inspections. When I did the registration (which he said that I needed to do) it caused my name to be added to the inspection database but it created an incomplete entry. So, they needed to determine if they had inspection jurisdiction or if it fell to state/local authorities.

He asked if we sold retail or wholesale and I asked him to define both because I wanted to make sure I was meeting their definition and not mine. They define retail as selling directly to a customer and retail as selling to a middle man at a lower rate. Based on that, we sell retail whether it's a restaurant or person. There were a few other questions about farmers markets or how are sales were conducted out of state but in the end he said that because we do not sell wholesale that we did not need to be in their inspection database.

I kind of chuckled when he said that they were getting a bunch of these lately and in order to save the tax payers money they are checking to see if these businesses are still in business or if they really met the criteria. That almost sounds to be like there was a coding issue that created all the entries and they are trying to clean it up but I can't say for certain. It still was funny that they said they were trying save tax payer money...lol.

[maple flats]

Is this individual you are referring to a bulk producer selling to a packer?
I don't know his numbers, but he only sells his Comm. and some of his B to a packer. He retails all of his grade A and some of his B. He told me his production last spring and most was grade A, but I don't recall the numbers. He had about 1000-1200 taps, all on high vac.

[red maples]

Yes that is how these read. Basically everyone is "supposed" to register with the FDA. Its pretty confusing though. So the way it does read though if you collect sap "only" you are a farm but it if toy make syrup then you are considered a food manufacturer. I have yet to see a sugarhouse (besides the Giant folks that sell mostly bulk and wholesale) that do not have open beams on ceilings and/ or walls. Sorry to those that get inspected.

[happy thoughts]

Yes that is how these read. Basically everyone is "supposed" to register with the FDA. Its pretty confusing though. So the way it does read though if you collect sap "only" you are a farm but it if toy make syrup then you are considered a food manufacturer. I have yet to see a sugarhouse (besides the Giant folks that sell mostly bulk and wholesale) that do not have open beams on ceilings and/ or walls. Sorry to those that get inspected.

It is confusing but the way I understand it is slightly different than yours.You can collect sap and make syrup and still be considered a farm as long as you sell retail directly to the public without worrying the FDA will inspect you.. But if you sell any to a packer you are subject to inspection because it goes through more than one "manufacturer" before the syrup is sold retail to consumers.

[red maples]

you may be correct... I do remember something about the retail only part from your farmers market or from the farm itself. I don't know... we'll see if it ever tricks down. if it does it does, not a whole hell of alot we can do can do about it.

I so have to say the saving tax payer $$$ is funny one. since when is anyone in Government concerned about our tax dollars. but thats another Thread ALLLLL to gether!!! but no on here as we aren't supposed to get political on here unless it concerns maple!!! So I will leave it at that!!!

[maplestudent]

I have never sold any that I have made (though I do give syrup to family & friends) and have assumed that I need not register with the FDA. Not sure if that assumption is correct. However I've been thinking of trying to expand my production by adding more tubing, using some vacuum (likely the shurflo pump method) and possibly adding another 30 to 40 trees, in hopes that maybe I can sell a little in order to offset some of the cost of making the most expensive free syrup around.

If I do that, it would seem that I would need to register. I don't have much to inspect though....since I boil outside in my back yard. And I take my tubing down. So right now I have rolls of tubing stored inside food grade storage barrels.

Can I even do that - boil outside and sell it? Legally?

[Ski Bum]

Well that's over with! It would have been easier to get into the White House!!! If you are re-upping just read the directions and re-type what they want from you. I guess it's for our own good, but I think the Feds could make it a little easier on us. I never was a computer wiz and never will be. I hope I remember all this in two years so I can do all over again. Good luck and have a great season.

[DoubleBrookMaple]

I registered last year, and received a phone call some months later. I answered all the questions, and the interviewer advised me that it was very unlikely I would get an inspection. I sell only a few gallons retail.
I renewed my registration a couple weeks ago to meet the biennial renewal requirements, as per the following off the FDA website.

"2014 Food Facility Biennial Registration Renewal
October 1, 2014 12:01am through December 31, 2014 12:59pm

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Please be advised that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31, 2014, the registration is considered expired and will be removed from your account. If you have any further questions please contact the FURLS Helpdesk: by phone 1-800-216-7331 or 301-575-0156; or by email FURLS@fda.gov. "

[red maples]

I registed last year... good luck!!! thats it. there are like 50 pages op so and there was nothing for maple I to put it in the "OTHER" column. I have to revisit it to see if need to do anything else.. not sure!!!

[gmcooper]

We registered back just before the deadline a year or two ago. I got my fancy FDA post card Saturday telling me to register or renew my registration. In fine print on bottom it say to ignore this if I have already registered.

[Michael Greer]

Why bother? Seriously, if they don't have the resources to run the program in a comprehensive way, don't even go there. I made a lot of very nice syrup last year....and then I sold it. Happy as can be, I'll do it again this year and if someone wants to know, they'll have to come and visit. My operation is pristeen and my syrup is perfect, and any intervention by the state or fed could only screw it up.

[GeneralStark]

We registered back just before the deadline a year or two ago. I got my fancy FDA post card Saturday telling me to register or renew my registration. In fine print on bottom it say to ignore this if I have already registered.

Actually what the card says is:"Please disregard this communication if you have already RENEWED your registration"

It appears that you have to renew your registration every two years, on even numbered years, so this year, 2014, is a renewal year. The renewal period is
10/1/14-12/31/14. If you don't renew it looks like they will cancel your account.

[DrTimPerkins]

I renewed the UVM PMRC registration a few weeks ago, and received this email yesterday afternoon.

Questions Regarding Whether Food Facilities are Required to Pay Registration Fees and Private Businesses Claiming or Suggesting an Affiliation with FDA
October 17, 2014
The United States Food and Drug Administration (FDA) has received a significant number of questions from food facilities regarding whether such facilities are required to pay registration fees or use third-party businesses in order to register with FDA. In response to these questions, FDA clarifies that there is no fee required to register a food facility with FDA and food facility registrants are not required to use a third-party business or “registrar” to register their facilities with FDA.
Additionally, FDA is aware that private businesses, such as “FDA Registrar Corporation” (FDA Registrar Corp.), are offering services (such as U.S. agent listing and registration renewal services) to food facilities. FDA would like to remind registrants that FDA is not affiliated with these private businesses, nor do they act on FDA’s behalf.
1. Food facilities that are required to register with FDA must register directly with FDA electronically, by mail or fax, or by CD-ROM for multiple submissions (21 C.F.R. 1.231). There is no fee to register with FDA (21 C.F.R. 1.231(d)).
A food facility may register, update, or cancel its registration itself (or authorize another person to do so on its behalf) using the Internet at http://www.access.fda.gov. Alternatively, a food facility may register, update, or cancel a registration by mail by requesting the appropriate form from U.S. FDA at 1-800-216-7331 or 301-575-0156 outside the United States, or by e-mail at furls@fda.gov.
U.S. Agents may charge a fee for their services, which is solely an issue to be decided between the food facility and the person who agrees to serve as the food facility's U.S. Agent.
2. Contrary to any suggestion by FDA Registrar Corp., food facilities do not need a certificate of registration. FDA does not issue a certificate of registration, nor does FDA recognize a certificate of registration issued by a private business. FDA issues a registration number to registered food facilities. Any registered food facility may obtain its registration number by contacting FDA.
3. Contrary to any suggestion by FDA Registrar Corp., food facilities that have registered and do not have their FURLS information or PIN should not re-register. Instead, a food facility can contact U.S. FDA for help at 1-800-216-7331 or 301-575-0156 , or by e-mail at furls@fda.gov.
A food facility will be asked to provide information on its company's letterhead signed by the owner, operator, or agent-in-charge of the facility to verify the information. Once FDA verifies the identity of the food facility, FDA will provide the facility access to its account.
Additional information on FDA food facility registration requirements, including FDA’s food facility registration regulation, can be found on FDA’s webpage at www.fda.gov. Further, additional information can be found on FDA’s webpage in the FDA Food Safety Modernization Act (FSMA) frequently asked questions section, specifically questions IC.3.8 and IC.3.11, at http://www.fda.gov/food/guidanceregu...m#registration. Registrants may also find additional information on food facility registration requirements in The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide and The Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). These guidance documents were last updated in December of 2012 and provide information on current registration requirements.
For more information about these requirements, please refer to the guidance documents and frequently asked questions referenced in this update or contact the FURLS Helpdesk by phone at 1-800-216-7331 or 301-575-0156 , or by e-mail at furls@fda.gov.

[lpakiz]

I received the same email yesterday. I have not yet renewed my FDA registration, so it looks like this Emailing is not related to renewals.

[Michael Greer]

I especially like the line, "US agents May charge a fee for their services, whis is solely an issue to be decided between etc." This sounds like an open invitation for bribes and the kind of off-the-books, old boy, and it's who-you-know bull that I don't want to have any part of.

[lpakiz]

Michael,
Read the correspondence a bit closer. The agents they are referring to are the people who will, or are, offering to register FOR you. They are a private company, hoping to make a buck doing something for you that you can do yourself, for free.
The EMail is from the government, warning you about this deceptive practice.

[GeneralStark]

I especially like the line, "US agents May charge a fee for their services, whis is solely an issue to be decided between etc." This sounds like an open invitation for bribes and the kind of off-the-books, old boy, and it's who-you-know bull that I don't want to have any part of.

I think you are misinterpreting what is being stated. They are using the term "Agent" to refer to someone that would act on behalf of a food facility and its owners to handle their registration matters for them. In this case, the agent could charge a fee for their services, but is not an employee or representative of the FDA. Instead they are a private contractor with no affiliation with the FDA.

It's like hiring an accountant to do your taxes. You pay the accountant for their services and the accountant determines the amount to be paid. You don't need to hire an accountant, but you may choose to and that is ok.

I think the issue is that individuals are attempting to take advantage of people by suggesting their private firm must handle the FDA registration process and that there is a fee involved. You pay, and they run away.

[RC Maple]

I can't find the thread now but it was a similar thread on registration - after reading it I thought the card I received from FDA could be disregarded since it was a biennial registration and I just registered last year. That must be incorrect - I just received a card in the mail too. Do we have to renew every year and the word biennial is meaningless?

[DoubleBrookMaple]

Do we have to renew every year and the word biennial is meaningless?

RC.... We both registered last year, which was an odd year (2013). We must all renew on even years.

[GeneralStark]

Has anyone else been receiving phone calls from the FDA?

[batsofbedlam]

Yup! Answered a few simple questions and was told we were to small to be visited.

[maple flats]

It sounds like maybe the Feds are making the renewal in even years regardless of where in a 2 yr. cycle you initially register. I registered in 2012, will renew before 12/31.

[JoeJ]

I received a phone call from the FDA in August to update my information. Nothing was said or asked about a renewal. Got an official FDA email in early October reminding me to renew my registration by Dec 31. Last week I got FDA postcard reminding me to "Renew and Update" my registration. I followed the postcard instructions and disregarded the postcard because I already renewed after the last reminder. What a waste of time and money.

[Jmsmithy]

We're having helluva time logging back on to update/re-register. Being an insurance agent I'm keenly aware of Federal websites and their completely disastrous quality (eg. Good 'Ol Obamacare !) so I was very careful to record username/password/pin/reg # etc etc...and...SURPRISE!!! Can't login!! Sent them an email Monday. If no response after tomorrow I'll try to get someone by phone for 730 Monday am.

Unreal.

[red maples]

So I did call Lori Holmquist, (her info is on I think the first page of this tread) and she said I am exempt from registering with the FDA because I sell Greater than 50% of my crop retail. As long as don't sell to a big food chain store (market basket, hannaford's Etc) then I am OK.

Cool she is even going to email me all the proper stuff so that if I get asked why I can pull the documentation. She's going to send me a link for the FDA website so I can go in and cancel my reg.

Sweet!!!

[southfork]

Had my FDA inspection today. Went very well, inspector extremely helpful.

[sapmaple]

Just re-registered with fda web site using my ID and PW. worked fine except made me change the PW Hopefully done for 2 years now that I'm on even year

[mellondome]

Southfork,
Your inspection was with the federal food and drug administration? Or with your state department of agriculture?

[southfork]

Had two previous inspections with the Department of Ag. This was a call from the FDA and all paperwork was on FDA letterhead. They may be contracting inspectors from various states, not certain.