FDA Food Safety Modernization Act Registration

[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.

[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/GuidanceComp...ce=govdelivery


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

[sqkcrk]

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.

[wildbranch2007]

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/GuidanceComp.../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.

[wildbranch2007]

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.

[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.

[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

[eqnox]

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.

[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.

[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?

[wildbranch2007]

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?

[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.

[wildbranch2007]

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
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/script...h.cfm?fr=1.227


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

[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.