I read the brochures available on the FDA website, as
I am a beekeeper, and have significant financial
interests in a bakery, and a used bookstore/coffeehouse.
http://www.cfsan.fda.gov/~acrobat/fsbtreg.pdf
http://www.cfsan.fda.gov/~acrobat/fsbtpn.pdf
I noticed that they included disclaimers at
the bottom of the inside covers.
As I do a lot of work for the gummit (that ought to help
you to sleep better at night!), I have a certain amount
of skill in reading and understanding government wording,
so I thought I'd translate and explain for other beekeepers
from the point of view of one who pronounces "government"
as "gummit", as I KNOW it can get very sticky at times:
===================================================
"This guidance document is a restatement of the Food and Drug
Administration's (FDA's) current requirements for registration
of food facilities presented in simplified format and language."
TRANSLATION: The wording of the law is complete gibberish,
so we thought we'd try to explain it in plain English.
"As guidance, it is not binding on either FDA or the public."
TRANSLATION: But don't hold us to anything we say here.
The law itself, even though an incomprehensible muddle
of jargon and legalese, is the law, and it must somehow
be obeyed, even if no one ever successfully translates
it into plain English.
"FDA notes, however, that the regulation that is the basis for
this pamphlet establishes requirements for all covered activities."
TRANSLATION: So, no matter who you are, you have to stop
what you are doing and make a choice: either (A) read this,
do what it says, and hope that what we say is accurate,
or (B) hire a team of lawyers, and hope that THEY can
understand it and explain it to you. Either way, it is a
gamble, and you are betting your livelihood.
"For this reason, FDA strongly recommends that affected parties
consult the regulation at 21 CFR Part 1, Subpart H, in addition
to reading this pamphlet."
TRANSLATION: On second thought, don't believe a single word we
say in this fancy color brochure, printed at taxpayer expense.
This brochure is useless, as only the language of the law itself
is "the law". Never mind that you can't understand it, the law
says what it says, and it will certainly be explained in detail
through enforcement actions, court rulings, fines, and other
processes that we use to inform you when you have screwed up.
(If it is any consolation, we here at the FDA think that even
Congress itself does not understand this law. Think about it!
How could anyone "poison" a large number of people unless they
poison a LARGE food supply? Any random reservoir would be a
more effective target for poisoning. Why bother tracking
small-scale operations at all? We kinda like our existing recall
process, and we know it works, but we have to do as we are told.)
"The Food and Drug Administration has prepared this guidance to
restate the legal requirements set forth in 21 CFR 1.225 through 1.243
concerning registration of food facilities under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002."
TRANSLATION: We had better give you a citation to the actual
wording of the law. We've only written two paragraphs so far,
but we have realized that we are wasting our time, and maybe
mis-informing people who could be fined, criminally prosecuted,
and maybe even have their inventory confiscated.
"This guide is intended to help..."
TRANSLATION: Yeah, 'help'. That's the ticket! We are 'helping'.
"...any entity, regardless of size, to comply with the regulations..."
TRANSLATION: The immigrant street-corner hot dog and ice cream vendors
who have yet to master English beyond 'You want onions?', let alone
hear of this new regulation, will be easy to arrest, hold without due
process, and deport. This is the actual fear over at Homeland Security -
a low-yield battlefield tactical nuclear device, bought from a rouge
supply Sergeant in a breakaway Soviet republic, smuggled in via Canada
in a 55-gallon drum of maple syrup, and deployed in an ice cream vendor's
cart in Lafayette Park, right across Pennsylvania Avenue from the White House.
(We here at the FDA think that those guys at Homeland Security have been
reading far too much Tom Clancy, but we aren't going to argue with
Lebensraum-Uber-Meister Ashcroft. We don't want to be held without due
process as "enemy combatants" either. We have families too, ya know.)
"...that require domestic and foreign facilities that manufacture/process,
pack, or hold food for human or animal consumption in the United States
to register with FDA."
TRANSLATION: Yes, we are imposing requirements even on people who
are governed by the laws of other countries, not even citizens or
residents of the USofA. Don't like it? Then don't try and ship us
any food. Did you really think that we were going to comply with
any of those "World Trade" agreements, and submit our biosecurity
and health concerns to the WTO's 'Office International des Epizooties'
(OIE) for their consideration? Come on! Even their name is in French,
for Pete's sake! You know that we consider France to be a member of
the 'Axis of Inaction'. Anyway, you saw what we did in Afghanistan
and Iraq - do you REALLY want to pick a fight with the only remaining
superpower on the planet? Call now, cruise missiles are standing by
to respond to your complaints!
"This document also serves as FDA's Small Entity Compliance Guide (SECG),
in accordance with section 212 of the Small Business Regulatory Enforcement
Fairness Act (Public Law 104-121)."
TRANSLATION: This is all you are gonna get from us, so don't try to
complain that you are a small business, and can't afford to spend the
money required to figure out if you have to comply with this law, or
are exempt. Yes, we know that we are required by law to make life
easier for small businesses like beekeepers, bakers, and hot dog vendors,
but the bottom line is that we can't clearly explain something that we
ourselves don't understand.
jim ("Carpe Guttur" - Seize the throat!)
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
-- Visit www.honeybeeworld.com/BEE-L for rules, FAQ and other info ---
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
|
