FDA Changes?

[Brewer636]

I haven't found much info on the changes that Senate Bill 150 would require for breweries. It appears that since we're under FDA regulation currently, the HACCP requirements would be increased, and likely other data and record keeping requirements as well. With the bill likely to pass in the coming month, I'd like to have a greater sense of the impact on small brewers (any selling more than $500,000 per year), as well as the compliance costs. Any good brewery focused sources of info on this? I know the local food movement is screaming mad about this legislation, but I'm not sure what it means for us.

[seattlefng]

we're under fda regulation?

[HinduKush]

It appears that since we're under FDA regulation currently,

When did that happen and please site references, links, etc.

[Brewer636]

FDA jurisdiction

The Law:
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.

Who must register?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.

Domestic facilities are required to register whether or not food from the facility enters interstate commerce.


The registration process is not difficult, but the compliance issues coming down the road may be another story.

[Gordie]

Its generally accepted that we're under the jurisdiction of the TTB to the exclusion of the FDA. Senate Bill 510, which just got out of the Senate by a vote of 75-25 (albeit with some procedural problems) specifically reiterates that alcoholic beverage producers are exempted from all but 8 of the FDA regs, and those are applicable if you're messing with food. So if you're a brewpub - yes. Package brewery - no.

[Brewer636]

Registration

From the TTB's website:

The Bioterrorism Act and the related FDA regulations affect TTB-regulated industry members who are: Bonded wine premises, breweries (including microbreweries and brewpubs that pack any beverages for off-site sale), distilled spirits plants, and alcohol beverage distributors, importers, warehouses, and wholesalers. If you have a question concerning the Bioterrorism Act's applicability to you, contact the FDA.

I know the Senate and House versions of the current bill (SB 510) still need to be reconciled, but do you have a link to the exemptions we're hoping for?

[anda]

Section 116 (http://www.govtrack.us/congress/bill...?bill=s111-510) states the exclusions for alcohol related facilities. We are all still regulated, have to register (and pay the increased fees), and have to comply with the import regulations of the Act. And the FDA has to coordinate with the TTB if they want to initiate any recalls. Even though breweries will be exempt, there will be fees associated with the registration now. I've seen anywhere from $100 per year to $500. But, I don't think those figures are set yet.

-Anda

https://www.legalbrewing.com

[Brewer636]

Thanks for the details on this legislation. The reference you offered allowed me to trace the specific sections of the Act easily. It doesn't appear too overbearing for small brewers at this point, thankfully.

Nice beer related legal blog you're offering. Good job.

[Gordie]

Sorry - should have been clearer. I was just talking about FDA jurisdiction. Bioterrorism registration is its own animal.

In the meantime, FYI and not that it matters much, with regard to SB 510, although the bill passed out of the Senate, there are issues in the house relating to a section that imposes a fee related to recalls of contaminated products. If those fees are subject to definition as taxes, the bill would have needed to have been originated in the House (bills containing any new taxes are to be originated in the House, not the Senate, by constitutional provision) and the Senate's passage would be of no legal effect. I'm no parliamentarian but I'm pretty confident that someone in the House has a procedural shell game to in mind to move it along...

[dogfishqc]

Something that interests me as well is the possibility of the requirement by the FDA for Brewers to post nutritional information on labels. I have been hearing this but cannot find good clear info on if and where this stands. Anybody out there know where I could find out some more on this?
Thanks,
Chad

[sbruslind]

FDA, TTB, beer nutritional labeling

Let me get these links into the Probrewer searchable database for FDA and TTB questions-

Good overview, pretty recent, FDA position on beer labeling-

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm166239.htm

note the links to FDA-TTB coordination.

On to the TTB-
Proposed rulemaking has been ongoing since the last century. Keep up on the developments by bookmarking
http://www.ttb.gov/beer/beer-rulemaking.shtml. Sign up for e-mail updates.

Following that list, I pull up a 2007 Federal Register publication of proposed wine and beer labels. Comments were extended into 2008.

http://edocket.access.gpo.gov/2007/pdf/E7-14774.pdf

This publication shows pictures of proposed labels.

The TTB presentation I saw at the Brewers/Vintners Symposium (UC Davis) in 2009 indicated that a final ruling and implementation schedule was imminent, which means in the next 5 years (2012-2014?) with a recognition that old label runs need to be worked off in an cost effective manner.

The event I'd like to attend, or have Probrewer cover, is the TTB national workshop, put on in Cincinnati every other year. Maybe contract Gary Spedding to attend and blog?
Anyone else find more recent progress on a 'Serving Facts' labeling roll out?
Happy New Year,
Scott Bruslind

https://www.analysislaboratory.com

[meadowstream]

This is a reply to the original post.

With the exception of fees, doing an HACCP analysis and using it to inform documentation and validation of the brewing process is pretty straightforward.

In general, you would take the steps of your brewing process and identify the critical-to-quality attributes in play for each step (many steps would have none) and then figure out what risk there is to each attribute (temp, sanitary conditions, yeast viability, etc.) at each step. For high risk items, you identify tests that you can execute and document to show that risk is not present, and for low risk items you just run simple verification/commissioning type tests.

This applies on the lab side, too, where you have identified release assays and criteria.

For a drug company this is a hassle but for a brewery it should be helpful and not costly - could even save money in short order because it makes you think about efficiency and quality from a new angle.

Hope this was on topic... I have examples of HACCP and FMECA forms if anyone needs them.

[sbruslind]

Alcohol labeling article on Fox News

fair and balanced-

http://www.foxbusiness.com/markets/2011/02/18/alcohol-nutrition-facts-brewing-stir/?intcmp=prn_baynote-js_Alcohol_Nutrition_Facts_Brewing_a_Stir

The HACCP topic is a good one. Maybe a post an example in the Probrewer library?
Best,
Scott

https://www.analysislaboratory.com

[gointomexico]

zombie resurection, fda regestration

I just did the fda regestration online after reading this, it was a cinch.

[GarySped]

Scott, I just got back to looking at the site and made a few posts today before finding this one. It is still up in the air as to the nutritional rulings but it is coming from the FDA (each state has to make its own decisions on interpreting the rules) but so far only if served in restaurants do you need to have nutritional information - protein, total carbs and sodium. It might be worth getting this average info on each beer in your portfolio in case consumers ask. Unless you radically change formulas or styles you'd only need to do this once for these parameters and that is fairly inexpensive for information that could be called for and to know what you are dealing with nutritionally for your consumers. If mandates come down the pike for the type of nutriional labeling seen on foods then that could get very expensive. I hope it won't go that far but you might need to deal with allergen statements and that can get a bit iffy and expensive.

If they only require the basis - folks - I say don't rock the boat. I personally think the FDA would like to oust the TTB and control beer and then we would be in totally different territory.