For those that are less legally inclined, I have written a small breakdown of the more pertinent aspects of this law:
This bill is titled, “H.R. 2749: Food Safety Enhancement Act of 2009”, and is a sweeping addendum to the FD&C; most pertinently, sections regarding the manufacturing, packaging, and [mis]labeling of food and food products. For the most part, this bill is protocol alterations – changes to the registration of your GMP facility, performance standards, yearly registrations – but what makes me nervous is certain ambiguous portions such as this:
(b) Contents- The regulations under subsection (a)--
‘(1) may set forth such procedures, processes, and practices as the Secretary determines to be reasonably necessary--
‘(A) to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into raw agricultural commodities that are from a plant or a fungus; and
‘(B) to provide reasonable assurances that such commodity is not adulterated under section 402;
‘(2) may include, with respect to growing, harvesting, packing, sorting, transporting, and storage operations, minimum standards for safety as the Secretary determines to be reasonably necessary;
‘(3) may include standards addressing manure use, water quality, employee hygiene, sanitation and animal control, and temperature controls, as the Secretary determines to be reasonably necessary;
‘(4) may include standards for such other elements as the Secretary determines necessary to carry out subsection (a);
‘(5) shall provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply; and
‘(6) may provide for coordination of education and enforcement activities.”
The language use here is troubling: “reasonably necessary”, for example, is a broad parameter rife with possibility for political meddling. What the Secretary deems reasonably necessary depends necessarily on the clamoring of both special interest groups and the public – obviously, given the current climate, “reasonably necessary” may be the elimination of food supplements as a whole. Further, the onus is removed from any sort of congressional or judicial oversight, and the Secretary is given full authority to determine what constitutes "reasonably necessary" for the safety of the public on an ad hoc basis. Another troubling bit:
(a) In General- Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
‘(h)(1) Each facility registered under section 415 shall be inspected--
‘(A)(i) by one or more officers duly designated under section 702 or other statutory authority by the Secretary;
‘(ii) for domestic facilities, by a Federal, State, or local official recognized by the Secretary under paragraph (2); or
‘(iii) for foreign facilities, by an agency or a representative of a country that is recognized by the Secretary under paragraph (2); and
‘(B) at a frequency determined pursuant to a risk-based schedule.
‘(2) For purposes of paragraph (1)(A), the Secretary--
‘(A) may recognize Federal, State, and local officials and agencies and representatives of foreign countries as meeting standards established by the Secretary for conducting inspections under this Act; and
‘(B) may limit such recognition to inspections of specific commodities or food types.
Again, the ad hoc basis in which the Secretary will purportedly grant or disallow official inspections is alarming. It continues with (4) and (5) of Sec. 105, by stating that there is to be “risk-based” inspections set at steady intervals, depending on the classification of the facility. Seems logical, right? However, (5)(B) and (5)(C) go on to state the Secretary may alter how your facility is classified on, again, an ad hoc basis, pursuant to public safety concerns, and; further, that he may “inspect the facility with more frequency than the guidelines set in (4)”, Wait, it gets better. Sec. 107(b)(A)(B)(C)(D) go on to state that, “[...any food manufacturer...] must maintain the full pedigree of the origin and previous distribution of the food” - put otherwise: no ingredient that does not have a full pedigree down to its original cultivation may be used in any product.
Sec. 109(p)(1)(i-iii) gets even better!
(1) IN GENERAL-
‘(A) REQUIREMENT- The Secretary shall require, as an additional condition of granting admission to an article of food being imported or offered for import into the United States, that a qualified certifying entity provide a certification that the article complies with specified requirements of this Act if--...
‘(B) CONTENTS OF CERTIFICATION- Such certification shall include such information regarding compliance as the Secretary may specify, and may be provided in the form of shipment-specific certificates, a listing of certified facilities or other entities, or in such other form as the Secretary may specify.
Again, the Secretary is being given the power to decide, willy-nilly, what constitutes accreditation when dealing with foreign manufacture. The Secretary’s office decides that your manufacturer’s accreditations and proof pursuant thereto are unsubstantial? Too bad, your import will be denied. Here is the piece de resistance:
Sec. 331(c) of the FD&C states the following on detention of “prohibited substances”: “if the officer or qualified employee has credible evidence or information...” and then goes on to state that he/she may order an immediate writ of cease production and recall on the product. Sec.132(b) amends this, dangerously, in two key ways:
a) “Credible evidence or information” is replaced with “reason to believe”;
b) “Presents a threat of serious adverse health consequences to humans or animals” is replaced with, “adulterated, misbranded, or otherwise in violation with any section of this act”.
Put otherwise: if any qualified FDA officer has reason to believe that your supplement or food stuff violates this addendum in any way, your food stuff or supplement may be recalled with a ten day notice; further, if you are found to be in violation of these completely willy-nilly and ad hoc regulations, you are subject to a maximum of ten years in prison, with a maximum fine of $500,000 dollars.
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