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  • From: "Lawrence F. London, Jr." <lflj@intrex.net>
  • To: permaculture <permaculture@lists.ibiblio.org>
  • Subject: [permaculture] HR 2749 Food Safety Enhancement Act of 2009
  • Date: Thu, 02 Jul 2009 22:06:04 -0400


--- On Fri, 6/26/09, Weston A Price Foundation <info@westonaprice.org>
wrote:


From: Weston A Price Foundation <info@westonaprice.org>
Subject: HR 2749 Food Safety Enhancement Act of 2009
Date: Friday, June 26, 2009, 5:55 PM



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
kind 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


Our postal address is
PMB #106-380
4200 Wisconsin Avenue, NW
Washington, District of Columbia 20016
United States





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