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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?
 
#30 ·
"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/
 
#31 ·
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?
 
#32 · (Edited)
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.”
 
#33 ·
#36 ·
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.
 
#37 ·
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.
 
#40 ·
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.
 
#42 ·
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:
 
#41 ·
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;
 
#43 ·
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?
 
#44 ·
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
 
#47 ·
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.
 
#50 ·
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?
 
#53 ·
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.
 
#52 ·
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.
 
#55 ·
...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
 
#57 ·
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?
 
#58 ·
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.
 
#59 ·
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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