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FDA Food Safety Modernization Act Registration

29K views 73 replies 11 participants last post by  wildbranch2007 
#1 ·
I Posted this Thread here because above all this will effect Commercial Beekeepers more than it will anyone else.

How has or will this mandetory registration effect you? What changes to your beekeeping operation will you have to make? If your State doesn't have Honey House Registration and Inspection Requirements what do youy expect to be the ramification of registering w/ the FDA? Obviously if one does not register one is subject to "criminal or civil penalties under the Food, Drug, and Cosmetic Act, as amended by FSMA."

How many of y'all will be registered or updated before the end of 2012?
 
#2 ·
where is honey listed in the act? i searched on it and no hits? I remeber you posting b/4 about getting a notification, is that how you found out about it. I checked my local bee club and the nyhoney produceres and no information that I can see. Penn. has honey house registration, I'll bee seeing a beek from there tomorrow and see if he has heard anything.
I was registered years ago but they never sent me any correspondence.
 
#8 ·
I expect it to be part of the fall meeting. Actually looking forward to hearing about it more. I believe the statute states something along the lines that honey and maple syrup operations are not subjected food processing licensing and thus inspection. Less of course we alter or as they put it adulterate the honey. So now I have to state I am not an expert with laws, I do not propose to be a lawyer. Just a hick in the sticks keeping bees and our wicked government off my back.

Though I often wonder why Maple Syrup production is in the same category being syrup producers alter the sap to turn it to sugar and sap can go bad very quickly if not properly handled.
 
#9 ·
We don't have mandetory Honey House Registration in NYS, but we are subject to inspection. I know folks whyo have been inspected in the past. It became obvious that there were bigger fish to fry and they just became impractical.

Honey and Maple Syrup carry few or no pathogens which can cause harm, so they have been exempt from food processing licensing and inspection, unless something is added to the honey. Such as flavorings in creamed honey.

Many other foods carry more danger if not handled properly, such as milk.

What I will predict is that no one at the eshpa fall mtng will know enough to say what is required ort how to go about doing what is required and what is minimally required. It woulkd be nice if we had an FDA or NYS Ag&Mkts expert on hand, but I doubt we will.

Be sure to say hi when you see me.
 
#12 ·
No closures I know of yet. Beekeepers in Georgia and Florida are a tight group. They might just get the heads up when inspectors leave one place going to the next. From what I hear, the inspectors are still learning, developing a sense of what is normal and what is a threat. As soon as they hit that first confrontational beekeeper/packer all bets are off. They will come down on you like cops after a high speed chase.
 
#13 ·
Haven't heard of any repercussions up this way. You learn when running a business to expect the worst from what begins as well intentioned initiatives such as this. The devil is always in the details. Your greatest fear is being at the mercy of an over zealous federal employee short on real life experiences but fresh from an FDA training seminar. I have recently seen it with the DOT (where nothing I do has changed except the time it takes to write out about $500 a year in checks) and I am expecting to eventually see it with the FDA. If I get an inspection notice my first call will be to my congressman to find out how I am supposed to comply with regulations that I have never seen.
 
#14 ·
I do believe in cleanliness and hygienic operating practices when harvesting our crop but I also point out to anyone and everyone that beekeeping is primary food production and we have to be able to work within practical guidelines for production. We produce a raw product, just as the farmer who produces grain for sale, or cattle, or eggs, or milk. Best operating practices have to be implemented, and by doing so we can help prevent source infection of food born illness but there are limits. It all has to be practical and affordable.

Here, if you package honey for sale, or package any other product for sale you have to have a registered facility and they are very strict on the standards in these facilities.
Our beekeeping industry has adapted a voluntary honey house registration plan. And this is to help give producers time to up grade and such. This is beneficial because it allows older producers to make retirement plans which will be phased out in short time, and allows younger producers to plan their capital spending with honey house registration in mind. Most all producers here are in favor of this initiative.
 
#15 ·
I would agree with that approach. We as beekeepers, though, need to know what needs to be done and what the timetable is and some degree of reason needs to be used. Is it really time well spent for FDA inspectors to be throwing their weight around at this point in time when there is no reason to think that anyone is getting sick from the product that we produce. Seems to me that the greatest threat to honey purity are off label concoctions that can taint the honey rather than problems with honey house cleanliness. Perhaps the FDA needs to spend more time looking at the end product than the process.
 
#16 ·
I absolutely agree.
AND tell me this,
If our honey does have to be processed in a registered facility, which would make our honey production documented right from the hive to the barrel,
then why would our honey still be priced against the un documented honey coming in from off shores. And by that I mean China. And if there are documents provided, does the government believe the documents behind that stuff????
 
#17 ·
A producer from around here went to Chili on a beekeeping business exploratory something or another.
On the record, the producers were very favorable and respectful of our strict Canadian food standards and guidelines.
Off the record, in the pub, the producers were laughing at our food standards and guidelines. They could not believe the extra costs the government placed on producers for tractability and registrations for facilities. To make a long story short, they told him that what happens in Chili and most every other country in the world is they give bribes. They actually budget in brides as one of their year business expenses to pass inspection and satisfy government requests.
And our honey is sold against this stuff? If food safty and food standards are that important to processors AND consumers then why are they even looking at this other stuff?
 
#18 ·
I see this registration being nothing more than an additional tax on the backs of those who are working hard for a living. It should not be up to the feds to enforce inspections and registrations on food. That is a local government function from towns/citys to state. Has honey ever caused a food borne illness?
Does honey promote food borne illness?

Though I understand this act isnt directed at honey, it will possibly affect us as beekeepers. Maybe the ABF should lobby the retarded law makers to help make sense of it all and keep us out.
 
#20 ·
Though I understand this act isnt directed at honey, it will possibly affect us as beekeepers. Maybe the ABF should lobby the retarded law makers to help make sense of it all and keep us out.
Which is sited in the ABF announcement. That an under $500,000.00 exemption was sought by a Senator. I didn't get whether it was granted. ABF recommends complying w/ the Act and applying for an exemption. What a bother.
 
#21 · (Edited)
how are you going to argue that to a bunch of bureaucratic who have never seen outside of an office building ? To them honey is food just as everything else
But they have the ticket book. So, what are you going to do when someone says "Hey, this window w/ one pane of glass which is stationery only has one screen. It has to have two." Supposedly actually happened.

They do have the ticket book and the means of backing up the issuing of them.
 
#23 ·
Apparently I did have a visit from an Inspector. Other than the initial visit, early in the Summer, I wasn't aware that any further inspection had taken place until I got my Health Certificate/Interstate Transport Papers.
 
#25 ·
I copied some interesting points for some of questions and answers fo the new act, the first says its delayed.
FDA delays Food Safety Modernization Act Registration Process



On September 28, the Food and Drug Administration announced that due to the complex clearance and implementation process they were unequipped to implement the food facility biennial registration procedure mandated by the Food Safety Modernization Act (FSMA) that was set to begin on October 1, 2012, This delay effects food manufacturers and food wholesalers that process and package food, not retailers. The FDA has not given any timeline as to when the system would go live online and has yet to give a decision on whether or not the registration deadline under FSMA will be extended past December 31. When registration renewal does become available, the FDA will issue new guidance which will supersede the existing guidance and will address the renewal requirement which againhttp://www.cficweb.org/wp-admin/edit.php will only affect food wholesalers, not retailers. When any new information becomes available, NGA will update the membership. << now its says exluding retailers in the bill I found where I thought it also said if you only retail you do
<< not have to be inspected but I couldn't find it to copy

IC.3.8 Is there a fee for registration, updating a registration, or renewal of registration?
No. There is no fee associated with initial registration, updating a registration, or renewing a registration.


IC.1.1 FSMA has several provisions on inspections and compliance. What will be new?
For the first time, FDA has been given an inspection mandate. The legislation requires inspections to be based on risk, and the frequency of inspections to increase. It calls for all high-risk domestic food facilities to be inspected within five years of the bill’s signing and then at least once every three years after that. Further, all other domestic food facilities are to be inspected within seven years of the bill’s signing and then at least once every five years thereafter.


F.1.1 Is there a registration fee required under FSMA?
FSMA does not require a registration fee to be paid by registered facilities.


F.1.2 Will there be a fee associated with FDA inspections?
There is no fee for an initial FDA inspection. FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems.
>> no fee for inspection but a fee for reinspection.

F.2.12 Will States conduct FSMA-related reinspections?
Generally, FDA intends to conduct all reinspections that could result in the assessment of fees under FSMA, even in the case where an initial inspection was conducted under state contract.

<< so if a state does the inpection and you have issues, the feds will reinspect you and charge you the $241 dollars an hour plus travel and hotels. So it would be my guess in N.Y. << where the don't now inspect, the the feds would do it.



F.2.13 How long does the responsible party have to pay the fees?
Payment must be made within 90 days of the invoice date.



F.2.14 What happens if the responsible party or U.S. Agent does not pay?
Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.


G.5 Does FDA have sufficient funding to implement the new rule?
The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented. For example, the inspection schedule in the legislation would increase the burden on FDA’s inspection functions. Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals



<<now g5 is the one I would get everyone includeing the bee clubs, individuals, national organizations to key on, get some of the indivuduals from tailgater to write up a nice form <<letter to our congresspeople and senaters and make sure it doesn't get funded. won't help but at least would give us something to do over the winter that would be constuctive.

I like rainy days some times.:)
 
#26 ·
this is a lawyers interpretation of the part of the law that I couldn't copy about retail being excempt from inspection.


A. Covered Facilities (this is a lawyers interpretation of the actual law.)



The FSMA requires FDA to amend the definition of "retail food establishment"

5 to clarify that the sale of food directly to consumers includes the sale of food at a roadside stand or

farmers’ market, sale and distribution of food through a community supported agriculture program,

6and sale and distribution of food through any other direct sales platform as determined by FDA. FSMA, § 102(c). FDA regulations currently exempt retail food establishments from the food facility registration requirement. 21 C.F.R. § 1.226(c). This amendment will clarify that, for purposes of determining whether a facility is a "retail food establishment," direct sales to consumers include sales at a farmers’ market, roadside stand, or other direct sales platform.



gave up trying to copy the part of the law due to copy issues, but this may meen if you only retail you don't have to register
 
#28 ·
well I'm modifying my buisness plan, I will extract only enough honey to sell retail, the rest I will load up the honey supers and deliver to the people that buy wholesale from me, and they can extact it and retail it like they do now, I had allready bought a trailer to haul the supers anyway. only thing I have to look up is if (I think its called phosmet(sp) gas that some beeks use to kill the extra bees will also kill SHB. I would only lose one large purchaser of my honey as they don't have a large extracting room. the price of they honey will have to rise for the added trips to there honey houses I would think. I'm also looking into the excemptions they talk about.
 
#29 ·
I wouldn't get too excited about it yet. It looks like everyone who sells honey will have to register. (I think i already did a few years ago) but there are supposed to be exemptions from the worst of the paperwork requirements under the Testor amendment. But it seems the rules are still being written... so it will be prudent to keep up with it.

Does anyone really believe China will obey these rules? I am sure they will have all the paperwork required. :rolleyes:
 
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