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On July 30, 2009,
H.R. 2749 cited as the ‘Food Safety Enhancement Act of 2009’ was passed
by the House of Representatives. It will now go to the Senate. Despite
what the title says about this being about Food Safety, it isn’t about
that. This legislation is a classic example of collectivization by
computer system. It establishes the government management structure and
requirements for the supply chain management system for food producers,
importers and exporters. [
Full Text of H.R. 2749 ]
H.R. 2749
“An Act to amend the Federal Food, Drug,
and Cosmetic Act to improve
the
safety of food in the global market, and for other purposes”.
If you own a farm,
you can keep the deed in your name, but it will be under new management
and you will become an unpaid employee of the government – induction
into government service by the incremental addition of reporting and
procedural requirements over a period of several years. Some people have tried to point to Sec. 5. USDA
exemptions to say that farms are excluded but they aren’t. The
exemption reads:
Sec. 5. USDA Exemptions.
(d) Farms – A farm is exempt from the
requirements of this Act to the
extent such farm raises animals from which food is
derived that is regulated under the Federal Meat Inspection Act, the
Poultry Products Inspection Act, or the Egg Products Inspection Act.
Your food animals are
covered under other legislation as indicated above and by the NAIS
Animal tracking system whenever the government IT System Architects can
slip it into law making it mandatory. But if you grow crops for
sale, you are still included in the H.R. 2749 legislation.
Section 101. Changes in Registration of
Food Facilities
(b) Annual Registration
(1)(A) The term ‘facility’ means any
factory, warehouse, or establishment (including a factory warehouse, or
establishment of an importer) that manufactures, processes,
packs, or holds food.
Under Section D, it
defines a ‘farm’ as being ‘an operation in one general physical location
devoted to the growing and harvesting of crops, the raising of animals
(including seafood), or both’. But you can only be considered a ‘farm’
for these purposes if you don’t sell anything you grow to anybody but a
consumer – with consumer being defined a ‘not a business’.
For the privilege of
having the government takeover management of your farm, you will have to
pay a $500 annual registration fee – subject to increases every year of
course. Failure to pay will be treated as a claim of the United States
Government against your property – presumably meaning, they can attach
it.
This legislation
defines some very expensive “science-based” analysis and reporting
requirements. Hazard and Food Safety specify Category 1 Facilities.
Farms may either be a Category 2 or Category 3 depending on whether food
is packed and labeled or whether it is just held.
- Hazard Analysis
- Food Safety Plan
– including description of recordkeeping procedures, distribution
history for tracing, storage procedures, preventative controls,
hazard mitigation, etc.
There are no
category qualifiers on the Food Defense Plan (FDP) so presumably it covers all
categories of facilities. The FDP requires the facility to identify
conditions and practices that may permit a hazard that may be
intentionally introduced including by an act of terrorism. This
assessment includes evaluating processing security, cyber security,
material security, personnel security, storage security, shipping and
receiving security, and utility security. Below, there is a
copy of the
section that contains the Food Defense Plan requirements. It's
worth reading to see what the government expects from farmers (and the
consultants they will have to hire to produce the report and do the
electronic submission).
My favorite section
in this legislation is the Access to Records section. It doesn't
appear to apply to farmers - YET but the M.O. of these writers of
legislation is that they work it like a puzzle - the frame first and
then filling in the pieces section by section. The chilling part
of it is the mandatory remote government access to the computer system
of a private business. Also, as a consumer of processed foods, item (B) is
unnerving because you have to know that when they read the report, it
will count as an inspection - rodent hairs and filth in the food
notwithstanding. Just be good at the paperwork and you'll slide
under the radar if you are a "chosen one" - a member of club -
authorized to own a business.
SEC. 106. ACCESS TO
RECORDS.
(a) Records
Access- Subsection (a) of section 414 (21 U.S.C. 350c) is amended...
...
`(2)
ADDITIONAL AUTHORITIES TO ACCESS RECORDS
REMOTELY; SUBMISSION OF RECORDS TO THE SECRETARY-
`(A)
REMOTE ACCESS IN EMERGENCIES-
If the Secretary has a reasonable belief that an article of
food presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary
may require each person who manufactures, processes, packs,
transports, distributes, receives, holds, or imports such
article of food, or any article of food that the Secretary
determines may be affected in a similar manner, to submit to
the Secretary all records reasonably related to such article
of soon as is reasonably practicable, after receiving
written notice (including by notice served personally and
outside normal business hours to an agent identified under
subparagraph (E) or (F) of section 415(a)(2)) of such
requirement.
`(B)
REMOTE ACCESS TO RECORDS RELATED TO FOOD SAFETY PLANS-
With respect to a facility subject to section 418 and 418A,
the Secretary may require the owner, operator, or agent of
such facility to submit to the Secretary, as soon as
reasonably practicable after receiving written notice of
such requirement, the food safety plan, supporting
information relied on by the facility to select the
preventive controls to include in its food safety plan, and
documentation of corrective actions, if any, taken under
section 418(e) within the preceding 2 years
`(C)
ELECTRONIC SUBMISSION- If the records required to be
submitted to the Secretary under subparagraph (A) or (B) are
available in electronic format, such records shall be
submitted electronically unless the Secretary specifies
otherwise in the notice under such subparagraph.
Now, combine the remote access with the
next section 'Traceability of Food' and the picture emerges of a
government managed network with full visibility of the supply chain for
food. Specifically, your food facility becomes a link in the
government system of control. It doesn't take a crystal ball to
figure out that initially, the remote access and trace will be used only
during an emergency but sometime down the road, there will be
legislation that will call for an open, always on, link.
SEC. 107. TRACEABILITY OF
FOOD. [emphasis added]
...
`(c) Tracing System for Food-
`(1) IN GENERAL- The Secretary shall by regulation establish a
tracing system for food that is located in the United States or is
for import into the United States.
`(2) INFORMATION GATHERING-
`(A) TRACING TECHNOLOGIES-
Before issuing a proposed regulation under this subsection, the
Secretary shall--
`(i)
identify technologies and methodologies for tracing the
distribution history of a food that are, or may be, used by
members of different sectors of the food industry, including
technologies and methodologies to enable each person who
produces, manufactures, processes, pack, transports, or
holds a food to--
`(I) maintain the full pedigree of the origin and
previous distribution history of the food;
`(II) link that history
with the subsequent distribution of the food;
`(III) establish and
maintain a system for tracing the food that is
interoperable with the systems established and
maintained by other such persons; and
`(IV) use a unique
identifier for each facility owned or operated by such
person for such purpose, as specified under section
1011; and
`(ii) to the extent
practicable, assess--
`(I) the costs and
benefits associated with the adoption and use of such
technologies;
`(II) the feasibility of
such technologies for different sectors of the food
industry; and
`(III) whether such
technologies are compatible with the requirements of
this subsection.
`(B) PUBLIC MEETINGS- Before
issuing a proposed regulation under this subsection, the
Secretary shall conduct not less than 2 public meetings in
diverse geographical areas of the United States to provide
persons in different regions an opportunity to provide input and
information to the Secretary.
`(C) PILOT PROJECTS- Before
issuing a proposed regulation under this subsection, the
Secretary shall conduct 1 or more pilot projects in coordination
with 1 or more sectors of the food industry to explore and
evaluate tracing systems for food.
The Secretary shall coordinate with the Secretary of Agriculture
in conducting pilot projects with respect to farms under this
subsection.
And of course, a "full pedigree" in a
food tracing system includes your employees - your payroll records.
But actually, this is not really a new requirement, it's just the
incremental implementation of yet another government enterprise system,
"The National
Human Resource Development (Management) System".
`(3) REGULATION-
`(A) IN GENERAL- Taking into
account information obtained through information gathering under
paragraph (2), the Secretary shall
issue regulations establishing a tracing system that enables the
Secretary to identify each person who grows, produces,
manufactures, processes, packs, transports, holds, or sells such
food in as short a timeframe as practicable but no longer than 2
business days.
`(B) SCOPE OF REGULATION- The
Secretary may include in the regulations establishing a tracing
system--
`(i) the establishment and
maintenance of lot numbers;
`(ii) a standardized format for
pedigree information; and
`(iii)
the use of a common nomenclature for food.
`(C)
COORDINATION REGARDING FARM IMPACT- In issuing
regulations under this paragraph that will impact farms, the
Secretary--
`(i) shall coordinate with
the Secretary of Agriculture; and
`(ii) take into account the
nature of the impact of the regulations on farms.
[ Both of which mean exactly
nothing ]
Importers
The section on food importers requires that
foreign facilities be registered, "certified and accredited" - which is
really nothing more than a shallow cya exercise. It sets an
indicator on the database in the registration section but it is only as
meaningful as the quality of certification agency and the honesty of the
auditor. The following are just a few noteworthy excerpts from the
section on importers.
"In issuing these
regulations, the Secretary may rely on or incorporate
international certification standards".
(6) ELECTRONIC SUBMISSION- The
Secretary shall provide in coordination with the Commissioner
responsible for Customs and Border Protection, for the electronic
submission of certifications under this section.
(Trusted
Shipper) [Note: Sec.
112 does not appear to be limited to importers and exporters.
It includes all registrants in the Food Safety Program.]
SEC. 112 REPORTABLE FOOD REGISTRY;
EXCHANGE OF INFORMATION
`(4) In carrying out this Act,
the Secretary may provide any information relating to food that
is exempt from disclosure pursuant to section 552 (a) of title
5, United States Code, by reason of subsection (b)(4) of such
section, or that is referred to in section 301(j)--
`(A) to any foreign
government agency; or
`(B)
any international organization established by law,
treaty, or other governmental action and having
responsibility--
`(i)
to facilitate global or
regional harmonization of standards and requirements in
an area of responsibility of the Food and Drug
Administration; or
`(ii)
to promote and coordinate
public health efforts, if the agency or
organization provides adequate assurances to the
Secretary that the agency or organization will preserve
the confidentiality of the information.
Usurpation of States
Rights This section is
very disturbing because they are attempting to exceed their
constitutional boundaries of regulating INTERSTATE commerce by
specifically legislating the authority to restrict the movement of food
products WITHIN state boundaries. One can see how this section
could be used to force farmers into the supply chain in case they try to
avoid being a sharecropper for the government by doing business only
within state boundaries. If the government gets away with this, it
will be the precedent they will use to require RFID chips on animals not
intended for interstate commerce and to control food sales from farms
within a state.
SEC. 133. AUTHORITY TO PROHIBIT OR
RESTRICT THE MOVEMENT OF FOOD.
(a) Prohibited Act- Section 301
(21 U.S.C. 331), as amended by sections 110 and 111, is amended
by adding at the end by adding the following:
`(ww) The violation of a
prohibition or restriction under section 304(i).'.
(b) In General- Section 304 (21
U.S.C. 334) is amended by adding at the end the following:
`(i)
Authority to Prohibit or Restrict the Movement of Food
Within a State or Portion of a State-
`(1) AUTHORITY TO
PROHIBIT OR RESTRICT THE MOVEMENT OF FOOD-
`(A) IN GENERAL-
`(i) After
consultation with the Governor or other
appropriate official of an affected State, if
the Secretary determines that there is credible
evidence that an article of food presents an
imminent threat of serious adverse health
consequences or death to humans or animals, the
Secretary may prohibit or restrict the movement
of an article of food within a State or
portion of a State for which the Secretary has
credible evidence that such food is located
within, or originated from, such State or
portion thereof.
`(ii) In carrying out clause (i), the Secretary
may prohibit or restrict the movement within a
State or portion of a State of any article of
food or means of conveyance of such article of
food, if the Secretary determines that the
prohibition or restriction is a necessary
protection from an imminent threat of serious
adverse health consequences or death to humans
or animals.
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`SEC. 418C. FOOD DEFENSE.
[emphasis added]
`(a) In General- Before a facility (as defined in section 418(i))
introduces or delivers for introduction into interstate commerce any
shipment of food, the owner, operator, or agent of the facility
shall develop and implement a written food defense plan (in this
section referred to as a `food defense plan').
`(b) Contents- The food defense plan shall include each of the
following elements:
`(1) A food defense assessment
to identify conditions and practices that may permit a hazard
that may be intentionally introduced, including by an act of
terrorism. This assessment shall evaluate processing security,
cybersecurity, material security (including ingredients,
finished product, and packaging), personnel security, storage
security, shipping and receiving security, and utility security.
`(2) A description of the preventive measures being implemented
as a result of such assessment to minimize the risk of
intentional contamination.
`(3) A description of the procedures to check for and identify
any circumstances in which the preventive measures are not fully
implemented or were ineffective.
`(4) A description of the procedures for taking corrective
actions to ensure that when preventive measures have not been
properly implemented or have been ineffective, appropriate
action is taken--
`(A) to reduce the
likelihood of recurrence of the failure; and
`(B) to assess the consequences of the failure.
`(5) A description of evaluation
activities for the preventive measures, including a review of
records provided for under paragraph (6) and procedures to
periodically test the effectiveness of the plan.
`(6) A description of the facility's record-keeping procedures,
including records documenting implementation of the procedures
under paragraphs (3), (4), and (5).
`(c) Hazard- For purposes of this
section, the term `hazard that may be intentionally introduced,
including by an act of terrorism' means a hazard
for which a prudent person who, as
applicable, manufactures, processes, packs, transports, or holds
food, would establish preventive measures because the hazard has
been identified by a food defense assessment by application of--
`(1) a targeting assessment tool
recommended by the Secretary by guidance; or
`(2) a comparable targeting assessment tool.
`(d) Food Defense Hazards Identified
by the Secretary-
`(1) ESTABLISHMENT- The
Secretary may establish by regulation or guidance preventive
measures for specific product types to prevent intentional
contamination throughout the supply chain. The owner, operator,
or agent of a facility shall implement any preventive measures
identified by the Secretary under this paragraph.
`(2) ALTERNATIVE MEASURES- Such regulation or guidance shall
allow the owner, operator, or agent of a facility to implement
an alternative preventive measure to one established by the
Secretary, provided that, in response to a request by the
Secretary, the owner, operator, or agent can present to the
Secretary data or other information sufficient to demonstrate
that the alternative measure effectively addresses the hazard.
`(e) Requirement to Reassess and Revise-
`(1) REQUIREMENT- The
owner, operator, or agent of a facility shall--
`(A) review the food defense
assessment under subsection (b)(1) for the facility and, as
necessary, revise the food defense assessment under
subsection (b)(1) for the facility--
`(i) not less than
every 2 years;
`(ii) if there is a change in the process or product
that could affect the food defense assessment; and
`(iii) if the Secretary determines that it is
appropriate to protect public health; and
`(B) whenever there is a change in the food defense
assessment, revise the preventive measures under
subsection (b)(2) for the facility as necessary to ensure
that for all hazards identified, the risk is minimized, or
document the basis for the conclusion that no such revision
is needed.
`(2) NONDELEGATION- Any revisions ordered by the Secretary under
this subsection shall be ordered by the Secretary or an official
designated by the Secretary. An official may not be so
designated unless the official is the director of the district
under this Act in which the facility involved is located, or is
an official senior to such director.
`(f) Recordkeeping- The owner, operator, or agent of a facility
shall maintain, for not less than 2 years, records documenting the
activities described in subsections (b) and (e).
`(g) Access to Plan-
`(1) ON INSPECTION- An officer
or employee of the Secretary shall have access to the food
defense plan of a facility under section 414 (a) only if the
Secretary, through an official who is the director of the
district under this Act in which the facility is located or an
official who is senior to such a director, provides notice under
section 414(a)(1)(C).
`(2) NONDISCLOSURE- A food defense plan, and any information
derived from such a plan, shall be exempt from disclosure under
section 552 of title 5, United States Code.'.
(3) PROHIBITION- Section 301(j) (21 U.S.C. 331(j)) is amended by
inserting after `entitled to protection' the following: `or a
food defense plan, or any information derived from such a plan,
under section 418C'.
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