From: "Weston A Price Foundation"
Subject: HR 2749 Food Safety Enhancement Act of 2009
Dear Members,
HR2749, the "Food Safety Enhancement Act of 2009" has passed out of
committee and is now on the floor of the house. As you can see from the
FAQs below, this bill would be an absolute disaster for small farms and
artisan food production.
Defeating this bill is our most urgent priority at the moment. Please
take a moment to read the Frequently Asked Questions below and then
proceed with the Action items as best you are able. We will need the
concerted efforts of thousands to defeat this dismal piece of
legislation.
More HR 2749 information is posted through links at
http://tinyurl.com/mnm34s
Anyone with additional questions is encouraged to contact the
Farm-to-Consumer Legal Defense Fund directly by calling 703-208-3276 or
emailing info@farmtoconsumer.org
Sincerely,
Sally Fallon Morell
ACTIONS TO TAKE
1. Call Your Representatives
Personal contact is an effective way to change hearts and minds. To find
your representatives, use the finder tool at www.Congress.org or call the
Capitol Switchboard at 202-224-3121. When contacting your
representatives, use examples from the FAQs to explain your opposition to
HR 2749.
2. Sign the Petition
HR 2749 has been moving quickly through Congress. If you have not already
done so, please send a personal message to your legislators through the
online petition "Oppose HR 2749" at http://tinyurl.com/lwble7
3. Donate to the Fund
Help the Fund continue its valuable service - helping small farmers and
protecting your access to quality food. http://tinyurl.com/lja2vj
======
FREQUENTLY ASKED QUESTIONS (FAQs)
HR 2749 - Food Safety Enhancement Act of 2009
NOTE: Answers are based on the June 17 Waxman version that was accepted
by voice vote of the House Committee on Energy and Commerce. Page
references are noted per this version posted at http://tinyurl.com/na33dz
Q1: Does FDA have jurisdiction over INTRAstate commerce?
A1: As a federal agency, the FDA has jurisdiction over INTERstate
commerce. For example, the prohibited acts regarding adulteration and
misbranding in the current Federal Food, Drug and Cosmetic Act (FFDCA)
all refer to INTERstate commerce. However, the existing law states that
"in any action to enforce the requirements of [FFDCA] . . . the
connection with INTERstate commerce required for jurisdiction in such
action shall be presumed to exist." [1a] Combined with court decisions
addressing the connection between INTRAstate and INTERstate commerce, it
is unclear what ind of showing defendants would have to make to rebut the
presumption and avoid federal regulation. The agency's regulatory power is
limited to commerce, however, so non-commercial activities (such as
growing your own vegetables for personal consumption) are not regulated.
Under current law, a business qualifying as a "food facility" must
register with FDA, even if that business only engages in INTRAstate
commerce. [1b] In addition, the agency can inspect the records of a
business that engages solely in INTRAstate commerce if there is a
"reasonable belief that an article of food is adulterated and presents a
threat of serious adverse health consequences or death to humans or
animals." [1c]
[1a] 21 USC 379(a)
[1b] 21 USC 350(d)
[1c] 21 USC 350(c)
Q2: Would HR 2749 expand the FDA's regulation of INTRAstate commerce?
A2: Yes. Under HR 2749, FDA's regulatory control over INTRAstate commerce
would grow considerably. The bill would allow for inspections of firms
whose business is strictly within a State. [2a] It would impose, among
other requirements, a mandate for all firms in the food business to
comply with national performance standards for various foods set by the
Department of Health and Human Services (HHS). [2b] It would also require
most firms in the food business to establish a traceback system for their
products, even if those products never cross State lines. [2c]
[2a] Section 105(a)-pp. 42-43
[2b] Section 103(b)-pp. 36-37
[2c] Section 107(c)-p. 54
Q3: I have a garden and sell produce at a road-side stand on my property.
Would HR 2749 apply to me?
A3: Yes, you would now have to follow federally-established standards for
growing produce. [3a] Produce not grown as required by these standards
would be considered as adulterated under the Federal Food, Drug and
Cosmetic Act (FFDCA). [3b] Further, you would be required to make your
business records available to FDA inspectors. [3c] The inspectors would
have the power to show up unannounced without a warrant to search your
records without any evidence whatsoever that you have committed a
violation of the law. If you refuse to let the inspector see your
records, you would be guilty of adulteration under FFDCA. [3d]
[3a] Section 104(b)-pp. 38-41
[3b] Section 104(a)-p. 38
[3c] Section 106(a)-p. 48
[3d] Section 207(a)-pp. 119-120
Q4: I sell produce from my garden at a local farmers market, under HR
2749 would I have to register as a "food facility" with FDA?
A4: Farms are exempt from the registration requirement under current
law. [4a] HR 2749 would not eliminate this exemption. "Farm" is narrowly
defined under current regulations [4b]; so, it is possible that many
farms that have not registered in the past, could be required to do so if
FDA has more resources at its disposal to enforce registration.
For example, a farm that sells vegetables straight from the garden (i.e.,
no processing) would not be a "food facility". If FDA strictly interprets
the definition of "farm", a farm that sells canned vegetables at the
market would be a "food facility" because canning is considered
"processing" under the law. [4c] Under federal regulation, a farm that
processes food would not be considered a "farm" for purposes of the
registration requirement unless ALL of the processed food is consumed ON
the farm. [4d]
Under HR 2749, those who sell vegetables from the garden at farmers
markets would be required to follow federal standards for growing produce
[4e]; and their business records would be subject to random warrantless
searches by FDA inspectors even if the agency has no evidence of any
violation of the law. [4f-see Q3/A3 above]
[4a] 21 USC 350d
[4b] 21 CFR 1.227(3)
[4c] 21 CFR 1.227(6)
[4d] 21 CFR 1.227(3)
[4e] Section 104(b)-pp. 38-41
[4f] Section 106(a)-p. 48
Q5: I own a bakery and sell my goods at a local farmers market, how would
HR 2749 apply to me?
A5: HR 2749 would apply to you in the following ways:
1 - Your bakery would qualify as a "food facility" and you would need to
register with FDA each year [5a] and pay an annual fee ($500 in 2010
[5b], and increasing in future years as indexed for inflation [5c]).
2 - You would have to register in electronic format. [5d]
3 - You would be required to have a unique facility identifier number. [5e]
4 - You would be required to conduct an analysis identifying potential
hazards at your food facility; and you must implement controls to prevent
those hazards from occurring as well as a plan for what to do in the
event that any do occur. [5f]
5 - If your products cross state lines, you must develop a FOOD SAFETY
PLAN. [5g-also see Q6/A6 below]
6 - You would also be required to establish and maintain a system for
tracing the food you produce. It is uncertain at this point what this
traceability system will require, but the requirements are likely to be
extensive.
[5h]
[5a] Section 101(b)-p. 6 [4b] Section 101(b)-p. 13
[5c] Section 101(c)-p. 14
[5d] Section 101(b)-p. 7
[5e] Section 206(a)-p. 118
[5f] Section 102(a)-p. 21
[5g] Section 102, sec 418A(a)-p. 28
[5h] Section 107(c)-p. 54-58
Q6: What will a FOOD SAFETY PLAN involve?
A6: Your FOOD SAFETY PLAN would have to include a hazard analysis that
identifies potential hazards in your operation. The plan must also
include descriptions of a variety of procedures you follow to prevent
hazards from occurring and corrective actions to take if any does occur.
In addition, you would need to describe your procedures for
recordkeeping, conducting recalls, and traceback. Further, the plan must
include how you ensure a "safe and secure food supply chain" for the items
and ingredients you use as well as how you implement any
science-based performance standards required by FDA. [6a]
[6a] Section 102, sec 418A(b)-pp. 29-30
Q7: I have read a summary of HR 2749 and am alarmed by the provision
giving the Department of Health and Human Services (HHS) the power to
quarantine any geographic area within the country. How broad is this
power?
A7: Under HR 2749, the HHS Secretary would have the power to prohibit ALL
MOVEMENT of ALL FOOD within a geographic area. No court order is needed
to exercise this power. The Secretary only has to notify the appropriate
official of the State(s) affected and issue a public announcement. [7a]
[7a] Section 133(b)-pp. 98-99
Q8: I am a raw milk consumer. Is it true that under HR 2749 would give
FDA the power to institute a complete ban on the sale of raw milk?
A8: Yes, HR 2749 requires the HHS Secretary to issue "science-based
performance standards . . . applicable to foods or food classes." The
Secretary is to "identify the most significant foodborne contaminants and
the most significant resulting hazards . . . and to minimize to an
acceptable level, prevent or eliminate the occurrence of such hazards."
[8a] FDA would have the power to make pasteurization of all raw milk a
performance standard. Based on both its public statements and its record
of taking enforcement actions against farmers, FDA is vehemently opposed
to the consumption of raw milk and would like to ban its distribution.
Even if FDA does not issue a performance standard requiring
pasteurization, the likelihood is that if HR 2749 passes into law, the
agency will be increasing its enforcement actions against raw milk
producers whose products cross state lines. FDA has indicated that raw
milk is a priority item with the agency; with the passage of HR 2749, it
would have much greater resources to go after raw milk than it did
before. FDA could take enforcement action directly or through state
agencies funded by FDA.
The way to stop this threat is to support HR 778, a bill that would, in
effect, end the ban on raw milk for human consumption in interstate
commerce. [8b] If you have not already done so, contact your
Representative and Senators asking them to co-sponsor and/or vote for HR
778. You may send a message to them through the petition service by
clicking on "Support HR 778 Now" at http://tinyurl.com/lwble7
[8a] Section 103(b)-p. 37
[8b] 21 CFR 1240.61
Q9: I purchase products from an Amish producer who has said he would not
register his facility because the electronic filing requirement violates
his religious beliefs. What are the criminal and civil penalties he could
be facing if he is charged with violating the law?
A9: Under HR 2749, failing to register a food facility would constitute
"misbranding." [9a] If any of the "misbranded" products are introduced or
"delivered for introduction into interstate commerce", the producer could
be sentenced to up to ten years and be assessed criminal fines. [9b]
Under HR 2749, anyone knowingly violating certain prohibitions contained
in the FFDCA such as the prohibition against introducing adulterated or
misbranded food in interstate commerce, could face these penalties.
In addition, the Amish producer could be facing substantial civil
penalties. Under HR 2749, any individual who knowingly violates a
provision of section 331 of FFDCA (prohibited acts) relating to food, can
be fined up to $100,000; a corporation can be fined up to $7.5 million.
[9c]
[9a] Section 101(a)-p. 6
[9b] Section 134-p. 100
[9c] Section 135(a)-p. 101
Q10: I'm a farmer who sells products direct to consumers. I want to
protect the privacy of those who purchase from me and do not want to turn
over to FDA any customer information I have in my records. What are the
potential penalties if I refuse?
A10: Under HR 2749, FDA would have access to all records relating to the
food producer's distribution of products. Failing to provide records to
FDA would constitute adulteration. [10a] The criminal penalty for
refusing access to records would be up to ten years imprisonment. [10b]
The civil fines could be up to $100,000 for an individual and $7.5
million for a corporation. [10c]
[10a] Section 207(a)-pp. 119-120
[10b] Section 134-p. 100
[10c] Section 135(a)-p. 101
More HR 2749 information is posted through links at
http://tinyurl.com/mnm34s
Anyone with additional questions is encouraged to contact the
Farm-to-Consumer Legal Defense Fund directly by calling 703-208-3276 or
emailing info@farmtoconsumer.org
We update our email list at the end of each month, to be removed from our
member email list, email info@westonaprice.org
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