# FDA Food Safety Modernization Act Registration



## sqkcrk

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?


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## wildbranch2007

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.


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## sqkcrk

An e-mail from ABF. Honey is a food. That's how it fits, I guess. ABF recommends registering and then applying for an exemption. Being less expensive than the criminal and civil fines.


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## jkola404

Our state already requires that if you are over certain size that you need to have your honey house inspected and registered. They don't inspect every year but have to pay the $70 dollar fee yearly.


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## Ian

Canada has a voluntary plan in action, and I do not see it being to much longer before it become mandatory also.


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## BMAC

Being that states have to abide by federal law I will wait and see how our ag and markets handle this being they have specific honey statutes.


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## sqkcrk

Who does? NYS? What honey statutes are those?

This will be a topic of discussion during the Fall Mtng of the Empire State Honey Producers Association Meeting.


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## BMAC

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.


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## sqkcrk

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.


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## AmericasBeekeeper

We have state regulation in Florida, but the honey houses are reporting that DHS is walking in and being more critical than the state inspections. I'd hate to go to Gitmo for cob webs around the lights.


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## sqkcrk

Are people having to stop their operations and make changes? Has anyone been closed down?


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## AmericasBeekeeper

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.


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## jim lyon

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.


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## Ian

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.


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## jim lyon

Ian said:


> 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.


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.


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## Ian

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????


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## Ian

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?


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## BMAC

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.


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## Ian

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


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## sqkcrk

BMAC said:


> 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.


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## sqkcrk

Ian said:


> 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.


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## BMAC

Mark speaking of apiary inspectors, have you had one out to your yards yet?


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## sqkcrk

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.


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## BMAC

Interesting. I have not seen nor heard from him yet. I will have to call Paul early next week after I finish pulling the rest of my honey.


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## wildbranch2007

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.


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## wildbranch2007

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


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## sqkcrk

But not direct store delivery of a food item never otherwise out of my hands? I sell almost all of the honey I produce directly to those who sell it to the end consumer.


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## wildbranch2007

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.


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## loggermike

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.


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## loggermike

"The Tester-Hagan Amendment, sponsored by Democratic Sens. Jon Tester of Montana and Kay Hagan of North Carolina, defines small farms as those that average annual gross revenue of less than $500,000 over three years and that sell a majority of their products directly to consumers, restaurants or grocery stores within the same state as the farm or within 275 miles of it. Farms that meet this definition will be exempt from developing a detailed food safety plan, keeping extensive records, and complying with produce safety rules the FDA will finalize over the next two years."http://www.foodsafetynews.com/2011/11/powerful-coalition-gains-exemption-for-small-farmers/


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## wildbranch2007

I've looked can anyone find where the amendment acutally passed? I've also read that it doesn't excempt you from being inspected even though they still haven't written the requirements that I can find any way. And the fda still gets to write up after the acutal bill was passed the requirements? I agree with loggermike better to keep up with it, but most of the information I find is dated 2010, thats 2 years old, whats happened in the last two years?


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## loggermike

Will keep looking for more recent news on this. I think you are right, the inspection part will apply to everyone. And you were also right, they intend to charge $221 per hour for any follow up inspections. I call that greedy.

Just found this: The Federal Food Safety Modernization Act: Impacts in Import and 
Small-Scale Production Sectors 

http://dash.harvard.edu/bitstream/handle/1/8592051/koenig.pdf?sequence=1

"Despite the opposition, the Senate bill passed with a modified version of the Tester 

Amendment.56 Members of the House did not have the opportunity to make changes to the bill 

before it was signed into law, but they did express their reservations regarding the Tester 

Amendment. Representative Pitts voiced a common concern, stating “[w]hile we do not want to 

overly burden small facilities and small farms, we’ve learned in our committee hearings that 

food-borne pathogens don’t care if you’re a big facility or a small facility, a big farm or a small 

farm. They affect everyone.”57 Others noted that the Tester amendment may require the 

government to “exempt similarly sized companies in developing countries from our standards.”


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## wildbranch2007

a post from bee-l from a person who had read the honey packers part of the bill






http://community.lsoft.com/scripts/wa-LSOFTDONATIONS.exe?A2=ind1211&L=BEE-L&F=&S=&P=47234







I looked over the new homeland security food
regulations for honey packers. You can't even keep a broom or mop with a
wood handle in the place. Clorox under lock and key.


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## BMAC

Pretty interesting article Bob wrote. It was dedicated more to CCD with just a little blurb about the homeland security trash. A fairly interesting political spin on it as well.


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## BMAC

So did anyone figure anything out after listening to the FDA lady about FSMA on Saturday?


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## sqkcrk

Unfortunately I did not get to hear her whole talk nor get to participate in the question and answer part. I heard she declined to say who would be exempt from Inspection. I can send you the link to the literature which she passed out. But I don't know if it will do you much good. Unless you are going to register.


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## BMAC

I did a brief search on FSMA exemptions and they are NOT clearly defined as exemptions. Less I am looking in the wrong spot. It seems like a huge headache for some of the things they would require for inspection worthy operations. Then the fear of having Dept of Homeland Security come and watch just to write citations is a nauseating thought.

Did you look in the back of the blue book that lady handed out for what they look at during inspections?

Some of it has to do with searching vehicles on the property. Does that mean I have to search my own vehicles on the property in case I might be a terrorist? 

I think the whole FSMA concept was poorly put together.


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## wildbranch2007

sqkcrk said:


> Unfortunately I did not get to hear her whole talk nor get to participate in the question and answer part. I heard she declined to say who would be exempt from Inspection. I can send you the link to the literature which she passed out. But I don't know if it will do you much good. Unless you are going to register.


could you post the link so we could all see it? thanks


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## sqkcrk

Will do, this evening. Gotta go do some work. Later guys.


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## BMAC

I couldn't let this rest. I called up FDA in Maryland. They told me on the phone exemptions: Home based operations, tax code 50133 (not for profit).

So I asked for where to find our exemptions on the internet and she gave me 
http://access.fda.gov

Click on the more information under food facility registration which brought me to the following:
http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637.htm#IIId


Which within clearly states FARMS are exempt.

Sounds like I am legally NOT required to register.


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## jim lyon

I don't know, there is a lot of stuff in there to digest. It may not be as simple as you are hoping. I did notice this: 

 [sbull] The definition of farm now includes facilities that pack or
hold food, provided that all food used in such activities is grown,raised, or consumed on that farm or another farm under the sameownership;


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## wildbranch2007

BMAC said:


> I couldn't let this rest.
> Click on the more information under food facility registration which brought me to the following:
> http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637.htm#IIId
> 
> 
> Which within clearly states FARMS are exempt.
> 
> Sounds like I am legally NOT required to register.


the problem I have with all the information that I find and others post is
D. Comments on ``Who is Exempt From This Subpart?'' (Proposed Sec. <-----notice the word proposed
1.226)

In the interim final rule, the title of this section has been <--- interim final rule
changed to ``Who does not have to register under this subpart?''

The government expect you to conform to the laws/rules and you should have registered and the laws/rules haven't been written/finalized but the law has been signed by the president, I know that "things" are moving faster in real life than the government can keep up with but I originally registered 10 years ago, they have had 10 years to do something. I expect a finished version b/4 its signed, then again I don't have that high of expectations. sorta like being charged with a crime, you sign the documents and the cop says he will fill in the details later. Even better IMHO (from the thread by the same name) everyone with a honey house that I know, when I ask what they think not a one has a clue that they should have registered. now got my blood flowing will go cause some trouble. :shhhh:


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## sqkcrk

What is interesting to me is that instead of asking what do I need to do to conform to the Law people ask questions about how do I get around this? It is not clear as to who is eligible for exemption, but isn't it clear that EVERYONE is supposed to register and apply for exemption? Or face the possibility of getting served w/ a fine?


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## wildbranch2007

sqkcrk said:


> What is interesting to me is that instead of asking what do I need to do to conform to the Law people ask questions about how do I get around this? It is not clear as to who is eligible for exemption, but isn't it clear that EVERYONE is supposed to register and apply for exemption? Or face the possibility of getting served w/ a fine?


no it is not clear that everyone has to register, NO ONE I KNOW EVEN KNOWS ABOUT THE LAW, I wouldn't either if you had not brought it up!!! I realize ignorance of the law is no excuse, but take a look around as I have, you are the only one that has brought up the subject in any forum that I frequent, none of the bee organizations have any thing on there web sites, at the last minuite the nyhoney produces got someone to speak and from your previous post they couldn't/wouldn't answer the question. Nothing I lookat/find is the final bill, I haven't found anything that says what the honey house must have to comply, the parts I have read say if your state already does inspections then they will still do the inspections, so I """assu me""" that things will stay the same in N.Y. as they have also not addressed how you will get inspected if your state doesn't do inspections. IMHO you must register as someone contacted you telling you to do so, no one has contacted me so I don't feel the need to register, In one of the incomplete preliminary pieces of work that I read, the EPA stated how many facilities they expected to register, so they must know(i don't really believe this) where these facilities are, and look at the number that they used it would also be quite apparent that they don't expect small honey houses to register or the number would have been considerably larger. Most of the people I have told about the inspection process and the possible $241 dollar an hr. cost to be reinspected said and I do quote here, they will continue processing honey until the get one violation and need to get reinspected, they will break up the bees into nucs and sell them off and go on vacation. They also expect that since all of them are/have been registerd beeks in NY that the state of NY or cornell at some point might point them in the correct direction. could you post the title of the blue book referenced previously so I can see if I can find that only. thanks 
I had better post or will get sent off to tailgater


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## wildbranch2007

BMAC said:


> I couldn't let this rest. I called up FDA in Maryland. They told me on the phone exemptions: Home based operations, tax code 50133 (not for profit).
> 
> So I asked for where to find our exemptions on the internet and she gave me
> http://access.fda.gov
> 
> Click on the more information under food facility registration which brought me to the following:
> http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637.htm#IIId
> 
> 
> Which within clearly states FARMS are exempt.
> 
> Sounds like I am legally NOT required to register.


I called the small buisness ass. they sent me to the fda which sent me to the same link as you posted above, problem is the government doesn't know what is going on either, if you look at the top of the document, you will find that this is the old law, not the current one in affect that they are still writing

date on the law above. October 10, 2003: now I'll go beat my head against the wall and ask the epa directly, last time it took over a year for a response.


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## sqkcrk

I got a notice from ABF, that's how I first heard about it. That's when I opened thgis Thread.

www.cfsan.fda.gov

www.fda.gov/fsma

Short of mailing you a packet, that's the best I can do.


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## wildbranch2007

thanks for the links, I had allready read most of that. I have been in contact with a large commercia beek. He got to read the information that was provided to a packer that has already been inspected, I'll quote his interpretations below if my mail account will ever open. yahoo is having tech. difficulties.

he said he is inspected by county and state, so as he reads the info provided, he doesn't have to register with the fda as they already know about him. He said he has also dropped all of his commercial accounts like super markets to eliminate the hassel that he would get from keeping them. I'll update this to his own words when my email comes back.


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## sqkcrk

I wonder why there isn't an effort against this Food Safety Act comparable to the antiSOI effort?


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## BMAC

Maybe there is an ANTI FSMA team like the anti SOI team. Which was fairly humorous and ended up getting nothing done last week.


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## wildbranch2007

sqkcrk said:


> I wonder why there isn't an effort against this Food Safety Act comparable to the antiSOI effort?


had to go look up anti soi , most everybody agrees that its probably a good idea, the problem still is they are writting it as they go, there communication skills are zero, we don't mind setting up the honey house to conform, if we knew the rules, have the time during the winter, and all the excess cash from honey sales to help fund the economy but no guidance.
How can you rise up against something when you only hear about it after its been signed into law?


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## BMAC

amen to that. 

The FDA rep didnt really have any valid answers at the meeting either.


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## sqkcrk

Mike, we have been talking about it, around it, passed each other about it, and all sorts of things in all sorts of ways in NY for going on 5 years now. It isn't Law yet. And probably won't be, unless Farm Bureau signs off on it, from what I have heard.

Lots of folks agree it isn't a good idea.


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## sqkcrk

BMAC said:


> amen to that.
> 
> The FDA rep didnt really have any valid answers at the meeting either.


I wish I had stayed in the room, but had to address the Wellness Workshop folks. The Rep has to be careful what she says or her job would be in jeapordy. Besides, she can't really say who can and who can't when the point is to get everyone on the rolls.


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## BMAC

I started a new SOI thread so SOI isnt confused with FSMA stuff.


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## deknow

...of course the farm exemption doesn't apply for buckets or barrels of honey bought in....and from the wording, it doesn't apply to your own honey if you do bring in honey from others. Of course, we already know that beekeepers commonly relabel this stuff as their own....

deknow


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## loggermike

So did everyone figure this thing out?

The latest from FDA:http://www.fda.gov/Food/GuidanceCom...encyResponse/ucm331959.htm?source=govdelivery

Clear as mud........


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## honeyshack

When we applied to be registered and set up our standards in the honeys house, in compliance with the CFIA Inspection and Registration program, one of the things that was said to me about getting the majority of beekeepers to be a registered food producing facility was so that they could tighten honey coming in from suspect countries.
It is easier to enforce standards on sub standard producing countries when the country imposing those standards meets it themselves. I agree with that concept.
Some of the changes in our honey house are a bit of a pain...ie logs, but some are really good. Food grade paint on the walls if they are not sheeted with tin or acrylic sheets. Protective covers on the light bulbs be it florescent or incandecent. And that is a good idea because if a bulb breaks, how do you find every last speck of glass or in the case of florescent, the gas, from the honey? To great of a risk for contamination. Add into it, handwashing, floor cleaning, staff training. 
We provide a food product which feeds the world, our country or just our community. In reality we are no different than meat packing houses, canneries, grocers bakeries, and milk plants. If they have food standards to follow, why should we not?


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## wildbranch2007

I'm still waiting for the final version, I have never found it safe to try and hit a moving target.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I just love it. when they use word like "current thinking" "does not operate to bind the FDA" ya got to love it. If they wrote the constitution like they write stuff now we would all be in trouble.


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## wildbranch2007

I'm not a lawyer, what does the following mean, I never get double nots correct.

from the MSMA
1.2 Q: [Added December 2012] Has the scope of who is required to register under section 415 of the FD&C Act changed?

A: No. At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations every other year. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States (21 CFR 1.225). For purposes of section 415, the term “facility” in relevant part does not include farms, restaurants, and retail food establishments (section 415(c)(1) of the FD&C Act; 21 CFR 1.226). <--- "for purposes of section 415 in relevant part does not include farms or is this saying farms are not included



§ 1.226 21 CFR Ch. I (4–1–11 Edition) 
§ 1.226 Who does not have to register <---- who does not have to register under this subart
under this subpart?
This subpart does not apply to the
following facilities:
(a) A foreign facility, if food from
such facility undergoes further manufacturing/
processing (including packaging)
by another facility outside the
United States. A facility is not exempt
under this provision if the further manufacturing/
processing (including packaging)
conducted by the subsequent facility
consists of adding labeling or any
similar activity of a de minimis nature;
(b) Farms; <----- This subpart does not apply to the following facilities
(c) Retail food establishments;

so do farms have to register???? I couldn't resist trying to read it. My wife says the double not means farms don't have to register and she's a higher authority than the gov. here


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## BMAC

higher authorities always prevail.


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## wildbranch2007

well I'm going to my last resort, I'm going to ask my senators and rep to let me know with either a ya or nay, do you think they will actually give it to me in writting or pass the buck? I'll let you know. there good at kicking the can, I want to see if they can also pass the buck.


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## eqnox

Standard disclaimer of I'm not a lawyer and I'm just now jumping into this thread. 

However I think 99% of the people are looking at the wrong exemption on registering the honey house. 

First did the FSMA require anyone new to register with the FDA? 

No. According to the link
A: No. At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA 

http://www.fda.gov/Food/GuidanceCom...encyResponse/ucm331959.htm?source=govdelivery 


So lets go look at guide lines for Section 415 and Small Entity compliance 
http://www.fda.gov/Food/GuidanceCom...FoodDefenseandEmergencyResponse/ucm331957.htm


Scroll down about half way and..
*These Facilities DON’T Have to Register*
*Private residences of individuals*, even though food may be manufactured/processed, packed, or held in them.

*Farms* — i.e., facilities in one general location devoted to growing and harvesting crops (washing, trimming outer leaves, and cooling produce are part of harvesting) and/or raising animals (including seafood). The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.


So if you are a individual extracting and packing your honey in your home then you don't have to register.


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## sqkcrk

wildbranch2007 said:


> well I'm going to my last resort, I'm going to ask my senators and rep to let me know with either a ya or nay, do you think they will actually give it to me in writting or pass the buck? I'll let you know. there good at kicking the can, I want to see if they can also pass the buck.


I have a dollar which says you won't get an answer. If you do it won't be definitive.


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## wildbranch2007

eqnox said:


> A: No. At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA
> 
> 
> So lets go look at guide lines for Section 415 and Small Entity compliance
> http://www.fda.gov/Food/GuidanceCom...FoodDefenseandEmergencyResponse/ucm331957.htm
> 
> 
> 
> *These Facilities DON’T Have to Register*
> *Private residences of individuals*, even though food may be manufactured/processed, packed, or held in them.
> 
> *Farms* — i.e., facilities in one general location devoted to growing and harvesting crops (washing, trimming outer leaves, and cooling produce are part of harvesting) and/or raising animals (including seafood). The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
> 
> 
> So if you are a individual extracting and packing your honey in your home then you don't have to register.


My interpretation differs slightly, not trying to argue.
A. How do you know that you weren't required to register previously. I couldn't figure it out when they first came out with it, my previous honey house was registered, they didn't reject me. its still registered as far as I know.

my definition of a private residence would be my house, Most honey houses are seperate building.

I do agree with the farm exclusion except if you want to sell honey you are not excempt. 
or consumed on that farm or another farm <--- you can eat the honey but not sell it.

so I'm still going to get an answer from my very smart elected officials. I worked with computers my whole life, manuals must be clearly written so mistakes are not made. these things are written so that lawyers get paid to interpret them.


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## wildbranch2007

sqkcrk said:


> I have a dollar which says you won't get an answer. If you do it won't be definitive.


I couldn't say it any better than you did, when I moved to N.Y. the first time I went to the trash incinerator, they wanted to fine me $500 because my load wasn't covered, I truthfully pleaded being stupid. I then sent an email to the DOT asking what the law was as I was new in the state. Got a call on my answering machine in a dialect that I couldn't understand, asked for an email reply, they refused. Emails are legal documents.


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## sqkcrk

Tarp your load just before you get to the transfer station. Unless you have an overly zealous Trooper in your area you won't be bothered. Tarping the load requirement is to lessen the amount of trash found on the sides of roads between your house and the transfer station. But you already knew that.

Seems like one could get an unsecured load ticket for trash flying off of a load.


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## wildbranch2007

well the point of asking them was to find out for instance do I have to net the bee hives I transport or was it only for trash, I bought a cap, fixed everything


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## eqnox

wildbranch2007 said:


> My interpretation differs slightly, not trying to argue.
> A. How do you know that you weren't required to register previously. I couldn't figure it out when they first came out with it, my previous honey house was registered, they didn't reject me. its still registered as far as I know.
> 
> my definition of a private residence would be my house, Most honey houses are sepate building.
> 
> I do agree with the farm exclusion except if you want to sell honey you are not excempt.
> or consumed on that farm or another farm <--- you can eat the honey but not sell it.
> 
> so I'm still going to get an answer from my very smart elected officials. I worked with computers my whole life, manuals must be clearly written so mistakes are not made. these things are written so that lawyers get paid to interpret them.



The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown*,* raised*,or* consumed on that farm 

It is the "or" that is important. You get to pick one out of the three. I think you can make the argument that the honey is "grown" at your farm. I would say if you purchase outside honey and pack it that it would need to be registered. 

The act only provided more power to the FDA not change who needs to register. (See above link) No need to register again. 

I know a lot of people complain that they don't want the FDA harassing them but as a purchaser of honey I like to know the places were my food is prepared is clean and safe. If you have reached the stage as a producer where you need an outbuilding to process your honey, it might be a good thing to have some rules in place. In most other aspects of the law, a private residence encompasses all outbuildings on the property. An attached garage is no different that a detached garage. However I can't find a official FDA definition of residence. 

I wish you well in your quest to speak with an elected official. I would think you would have more luck in talking to the FDA and asking them to update the FAQ to speak to honey.


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## sqkcrk

No one will tell you what you don't have to do, lest they be wrong, they will only tell you what you do have to do. Then if they are wrong they aren't going to loose their job and won't embarrass their Boss.


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## loggermike

15.3 Q: Most sugar makers in Massachusetts operate from their own property, on which their private residence is also located. Are these sugar makers required to register the facility that is on their property and used for sugar production?

A: Under 21 CFR 1.227(b)(2), a private residence is not a "facility" and thus, is not required to be registered. A private residence must meet customary expectations for a private home and does not otherwise include commercial facilities in which a person also happens to reside. A private residence includes the parcel of real property on which the residence is located. Accordingly, if the sugar production occurs in the private home or in a detached building that meets customary expectations for use as part of the private home, such as a detached garage that has not been modified for manufacturing and processing so that it can no longer practically be used as customary for a garage, the home or building would not have to be registered. If, however, a separate building located on the real property of the private residence site is used as a sugar manufacturing or processing facility and does not have a use as customarily expected for a private residence, that facility must be registered, unless that facility qualifies for another exemption (e.g., as a retail facility; 21 CFR 1.227(b)(11))." end quote.

So if you extract in a garage between buckets of paint and cans of gas , etc. you would not have to register. but if you cleaned it all up so there was no use but honey processing, then it needs registering as a facility?
What kind of sense does that make?


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## wildbranch2007

loggermike said:


> So if you extract in a garage between buckets of paint and cans of gas , etc. you would not have to register. but if you cleaned it all up so there was no use but honey processing, then it needs registering as a facility?
> What kind of sense does that make?


thats right I remembered reading that one but going back for my last post didn't take the time to find it. Now if it said honey instead of sugar I would be in. I was planning on moving my extracting operation back into the garage anyway so I'm ok. I'm waiting to ask my politicians in hopes that we go over the fisical cliff, mayby they won't have any money left to pay people to come check on me. I really am enjoying this thread. Being from Mass. I had to go look up who the sugar manufactures are, they mean Maple syrup manufaturers I think. Now I have to go back and read it again because I thought that was addressed in another area?


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## loggermike

I assumed they meant maple syrup producers.This was the other reference to them:

9.14 Q: Are maple syrup producers “farms” and, thus, exempt from registering?

A: The response to this question depends upon the activities of the maple syrup producer. The activities of maple syrup producers customarily consist of two types: gathering sap from sugar maple trees and concentrating the sap through the application of heat to make syrup. Gathering sap is "harvesting," which is included in the definition of farm (21 CFR 1.227(b)). The “farm” is exempt from registration. However, concentrating sugar maple sap by heating is a form of manufacturing/processing (21 CFR 1.227(b)). Accordingly, a facility that concentrates sugar maple sap is performing a manufacturing/processing activity and is required to be registered, unless all of the concentrated sap is consumed on the farm or another farm under the same ownership."

Not really sure how much of this is relevant to a honey operation. I think I am going to pass on the whole thing.


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## wildbranch2007

loggermike said:


> I assumed they meant maple syrup producers.This was the other reference to them:
> 
> However, concentrating sugar maple sap by heating is a form of manufacturing/processing (21 CFR 1.227(b)). Accordingly, a facility that concentrates sugar maple sap is performing a manufacturing/processing activity and is required to be registered, unless all of the concentrated sap is consumed on the farm or another farm under the same ownership."


I can work with that, if you heat your honey you have to be inspected:thumbsup:
actually I think I have figured out what they are trying to say, unfortunatly (21 CFR 1.227(b)) isn't of the fda's web site. when it becomes available we may know if we are excempt or not.





1.2 Q: [Added December 2012] Has the scope of who is required to register under section 415 of the FD&C Act changed?

A: No. At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations every other year. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States (21 CFR 1.225). For purposes of section 415, the term “facility” in relevant part does not include farms, restaurants, and retail food establishments (section 415(c)(1) of the FD&C Act; 21 CFR 1.226). 


the above says i think that farms are excempt from section 415, except they then proceed to answer all kinds of question about farms, but I think they are actually referencing 21 CFR 1.227 for all the answers so now I'm going to look at 21 CFR 1.227.


I looked at 21 cfr 1.1227 and this gives you your defenitions, of course,as with everything else it hasn't been updated with the final changes.

and how they can answer about Maple Syrup for instance when Maple syrup isn't in 21 cfr 1.1227 is interesting.

they also referece for instance 21 CFR 1.227(b)(2). there is no 1.227(b) (2) in the below version of same.


I remember reading somewhere that they wanted to leave the authority that controled the entitiy. ie farms fda, so the epa tells the fda to modify there rules.




http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1.227


I'm with loggermike until I see something in writting.


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## wildbranch2007

I thought about it and decided I would ask first if anyone objects to me opening a question with epa, fda, and my senators, can't do rep until the new ones take offfice. Right now nobody knows the answer, on the slim chance that they do give me an answer and its negative, then you wouldn't have an out saying you didn't think you were required to file.
One objection and I'll let it pass.


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