Any farmers here might be interested in this.
It is a proposed bill that will add more regulations to domestic food production and storage.
Some of the criticism is that it will shut down small time farmers because of the immense paper work and inspection requirements plus a hidden tax of $500 a year "to be adjusted with inflation".
Additionally the way crops are grown will all be controlled by the FDA.
Here is the actual bill.
http://www.govtrack.us/congress/billtext.xpd?bill=h111-2749Here is an article from the Farm-to-Consumer legal defense. I will post the conclusion first if you don't want to read the whole thing.
http://www.ftcldf.org/news/news-15june2009.htmVI. CONCLUSION
The
FSEA gives the Food and Drug Administration tremendous power while
making the agency less accountable for its actions. It fails to
describe how the resources it provides are to be allocated. The
industrial food system and food imports are badly in need of effective
regulation, but the bill does nothing to prevent FDA from concentrating
a disproportionate amount of its resources on local food producers.
The
stated purpose of the FSEA is to “improve the safety of food in the
global market.” It was disclosed at the June 3rd hearing that, out of
the 378,000 food facilities that have registered with FDA, 220,000 of
them are foreign facilities that export to the United States. Rep.
Dingell commented that the percentage of our food coming from out of
the country will increase in the future. This creates massive food
insecurity in our country, yet the bill continues to push the federal
government’s policy of food interdependence.
While
information FDA obtains may be exempt from disclosure under the Freedom
of Information Act [5 USC 52(a)], it may still be provided “to any
foreign government agency; or any international organization
established by law, treaty or other governmental action and having
responsibility–to facilitate global or regional of harmonization of
standards and requirements in an area of responsibility of the Food and
Drug Administration; or to promote and coordinate public health efforts
. . .” [section 112(b)(4)–p. 71].
Food
security is achieved by becoming as self-sufficient as possible in food
production. Lessening the regulatory burden on small farms and local
artisanal producers will improve both food security and food
safety. If the FSEA is implemented, many small producers will not have
the economies of scale to be able to comply with its onerous
requirements.
The Food Safety Enhancement
Act needs to be defeated. Any food safety bill should target
industrial food processors and imports while leaving the local food
system alone. Readers need to contact their Representatives to urge
them to oppose the bill. To contact legislators by zip code, use the
finder tool at
www.Congress.org or call the Capitol Switchboard at 202-224-3121.
Article
HR 2749 - The Food Safety Enhancement Act of 2009
On May 26, leading members of the
House Energy and Commerce Committeereleased a discussion draft of the Food Safety Enhancement Act of 2009
(FSEA). Committee members supporting FSEA include Chair Henry Waxman
(D-CA), Chair Emeritus John Dingell (D-MI), Frank Pallone (D-NJ, Chair
of the Health Subcommittee), and Bart Stupak (D-MI, Chair of the
Oversight and Investigation Subcommittee).
Even before the FSEA was formally introduced, the
Health Subcommittee held
a hearing on the discussion draft on June 3. (Six other food safety
bills have been introduced, but none have gotten a hearing yet.) The
discussion draft, with some changes, was introduced as HR 2749 on June
8 by Rep. Dingell. Rep. Pallone introduced an amendment “in the nature
of a substitute to HR 2749″ on June 10. This
version of HR 2749has been voted out of the Health Subcommittee and is now headed to the
full Energy and Commerce Committee for mark-up on June 17. The bill is
on the fast track.
Passage of the FSEA
into law would amend the Federal Food, Drug and Cosmetic Act (FFDCA).
The bill proposes a substantial increase in power and resources for the
Food and Drug Administration (FDA) and would significantly diminish
existing judicial restraints on actions taken by the agency. Although
the bill includes some provisions that could improve the mainstream
food system, many of these are vaguely worded and do not clearly
define the scope of the agency’s power, creating the potential for
inappropriate application and enforcement. Small farms and local
artisanal producers are part of the solution to the food safety problem
in this country; the bill would impose on them a one-size-fits-all
regulatory scheme and would disproportionately impact their operations
for the worse. A detailed analysis of some of the key provisions is
below [the citations are to the relevant section and page number of the
June 10 version of the bill].
The
Farm-to-Consumer Legal Defense Fund is opposed to HR 2749 because it
would adversely impact small farms and food producers, without
providing significant reforms in the industrial food system. HR 2749
does not address the underlying causes of food safety problems,
including industrial agriculture practices and the consolidation of our
food supply.
I. REGISTRATION REQUIREMENTS
Under
current law, all “food facilities” are required to register with the
Secretary of the Department of Health and Human Services (HHS) [21 USC
§ 350d]. The registration requirement is for one time only and no fee
is charged. The FSEA would amend the current law to add significant
requirements.
A. ANNUAL REGISTRATION FEE
The
FSEA would require facilities to register annually [section
101(b)(1)–p. 3], rather than a one-time registration. Registrants
would also be required to pay an annual fee of $500, to be adjusted for
inflation [section 101, Part6, sec 743(b)(1)(A)–p. 10].
B. LIMITED EXCLUSION FROM REGISTRATION FOR FARMS
The
term “facility” does not include “farms” for purposes of registration
in either the current law or under the bill [21 USC § 350d(b)(1)]. But
what exactly is a “farm”? The FDA’s current regulations take a very
narrow view of what qualifies as a farm:
“…a
facility in one general physical location devoted to the growing and
harvesting of crops, the raising of animals (including seafood), or
both. Washing, trimming of outer leaves of, and cooling produce are
considered part of harvesting. The term “farm” includes:
“(i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and
“(ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.” [21 CFR § 1.227(3)] (emphasis added)
“Manufacturing/processing”
is defined as “making food from one or more ingredients, or
synthesizing, preparing, treating, modifying or manipulating food,
including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging.” [21 CFR § 1.227(6)] In other words, any farm that makes
jam, cans vegetables, or packages cut fruit would not be considered a “farm” under the regulation unless the food is consumed only on the farm!
In a subsequent
guidance document,
FDA expanded the definition of “farm”: “The term ‘farm’ also includes
facilities that manufacture/process, pack, or hold food, provided that
all food used in those activities is
grown, raised, or consumedon that farm or another farm under the same ownership.” (emphasis
added). Under the guidance document, a “farm” can process food if the
raw ingredients are grown or raised on that farm. In other words, a
farmer could make lacto-fermented foods from his own produce; but a
farmer who obtains produce from a neighbor to make such foods (unless
consumed there) would no longer be considered a “farm” and would be
subject to FDA registration.
Even under
the guidance document, many small farms and artisanal producers could
be required to register. FDA has not enforced this requirement
strictly so far, but that is no guarantee about future actions by the
agency. And if the agency were to revoke the guidance document and
enforce the registration requirement in accordance with the definition
of “farm” contained in the regulations, many farms would be required to
register and, under the FSEA, pay an annual fee.
B. ELECTRONIC REGISTRATION
The
FSEA would also mandate that registrations be submitted in electronic
format only [section 101(b)(1)(C)–p. 4]. Amish and Mennonite food
producers having to register would thus be faced with a choice of
violating either their religious faith or the law, while other food
producers could face added expense and problems if they do not have the
necessary technology. Failure to properly register would constitute
misbranding and would be a violation of the law [section 101a–p. 3].
C. UNIQUE FACILITY IDENTIFIER
All
food facilities required to register would also be required to have a
“unique facility identifier” [section 101(b)(2)(G)–p. 6]. “The
Secretary may, by guidance, specify the unique numerical identifier
system to be used . . . .” [section 206, sec. 911 (c)–p. 101]
II. QUALITY CONTROL FOR REGISTRANTS
A. HAZARD ANALYSIS & PREVENTIVE CONTROLS
Under
FSEA, the owner, operator or agent of a facility that must register
must also undertake extensive paperwork requirements including the
following:
1. Conduct a hazard analysis (or more than one if appropriate);
2. Identify, implement, and validate effective preventive controls;
3. Monitor preventive controls;
4.
Institute corrective actions when monitoring shows that preventive
controls have not been properly implemented or were ineffective;
5. Conduct verification activities;
6. Maintain records of monitoring, corrective action, and verification; and
7. Reanalyze for hazards. [section 102(b), sec 418A(a)–p. 18]
Failure
to comply with any of these requirements would constitute adulteration
under section 102(a) [p. 17]. These requirements apply even if a
facility engages solely in intrastate commerce, such as a local baker
selling at a farmers market.
B. FOOD SAFETY PLANS
Before
a facility can ship any food in interstate commerce, a written food
safety plan must be developed and implemented. The plan must include
the hazard analysis and any reanalysis as well as a description of each
of the following elements:
- preventive controls being implemented;
- procedure for monitoring preventive controls;
- procedures for taking corrective action;
- verification
activities for the preventive controls, including validation, review of
monitoring and corrective action records, and procedures for
determining whether the preventive controls are effectively preventing,
eliminating, or reducing to an acceptable level the occurrence of
identified hazards or conditions;
- recordkeeping procedures;
- procedures for the recall of articles of food, whether voluntarily or when required;
- procedures for the trace back of articles of food, whether voluntarily or when required;
- procedures
to ensure a safe and secure supply chain for the ingredients or
components used in making the food manufactured, processed, packed,
transported or held by such facility; and
- procedures to implement the science-based performance standards issued. [section 102, sec 418A (a)(2)–pp. 24-26]
The
requirements for the hazard analysis, preventive controls and the food
safety plan will strain the time and resources of small producers,
putting many of them out of business. As a result, consumers will lose
local food sources and be forced to obtain more of the foods from the
industrial system–the system responsible for the food safety problems
in the first place.
C. RISK-BASED INSPECTIONS
Finally, all registered facilities will be subject to federal inspection even if they engage only in intrastate
commerce. In contrast, under current law, inspection can be made only
of a “factory, warehouse or establishment” of a firm engaged in interstate
commerce [21 USC 374(a)(1)] Note that the massive recalls during the
last several years have all involved facilities that shipped interstate.
The
FSEA charges the Secretary with implementing an inspection schedule
with the frequency of inspections dependent on the “risk presented by
the facility”. Under the FSEA, “any facility that manufactures or
processes raw products of animal origin” would be a high-risk facility
and could be subject to inspections as frequently as every six months
[section 105(a)–p. 36]. Refusing an inspection would constitute
adulteration under the FSEA [section 207(a)–p. 101].
III. RECORDKEEPING AND TRACEABILITY REQUIREMENTS
Beyond registration, farms would not be exempt from several onerous requirements under the FSEA.
A. RECORDKEEPING
Under
the FSEA, all food producers would have to make their records available
to FDA inspectors. Under current law, FDA can examine the records of
those in the food business (excluding farms and
restaurants) 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” [21 USC 350c(a)]. Under
the FSEA, all those in the food business, including
farms, must turn over to FDA inspectors all records “bearing on whether
the food is adulterated, misbranded or otherwise in violation of this
Act . . .” [section 106(a)–p. 39]. This requirement “applies to all
records relating to the production, manufacture, processing, packing,
transporting, distribution, receipt, holding of [food]” that is
maintained “in any format and at any location.” [section 106(a)–pp.
39-40]
In other words, FDA would now be
empowered to go on a ‘fishing expedition’ and search records without
any evidence whatsoever that there has been a violation. Even farmers
selling direct to consumers would have to provide the federal
government with records on where they buy supplies, how they raise
their crops, and a list of customers. Refusing a records inspection
would constitute adulteration [section 207(a)–p. 102].
B. TRACEABILITY
The FSEA charges the HHS Secretary with establishing a tracing system for food:
Such regulations shall require each person who produces, manufactures, processes, packs, transports, or holds such food–
- to maintain the full pedigree of the origin and previous distribution history of the food;
- to link that history with the subsequent distribution history of the food;
- to
establish and maintain a system for tracing the food that is
interoperable with the systems established and maintained by other such
persons; and
- to use a unique identifier for each facility for such person for such purpose. [section 107(c)(2)(A)(i)–pp. 43-44]
The tracing
system must enable 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.” In issuing related regulations, the Secretary may
include:
“(A) the establishment and maintenance of lot numbers;
“(B) a standardized format for pedigree information; and
“(C) the use of a common nomenclature for food.” [section 107(c)(3)–p. 45]
“Pedigree”
is not used in reference to food anywhere in the United States Code
(USC) or the Code of Federal Regulations (CFR) nor is it referenced as
such in any dictionary. FDA is being given power to invent a new
meaning for this word. How far will the traceback extend to determine
the full pedigree? Will it go back to the animal or harvested crop (or
even seed) from which the food is produced? How will traceback be done
on multi-ingredient foods? Will part of determining the full pedigree
require tracing the inputs used in food? How large a database will be
needed to store this information? What will the cost of it be? How
many people will FDA have to hire in order to enforce traceability?
There is an exemption from the traceability requirements for direct-marketed food, “if such food is–
“(i) produced on a farm; and
“(ii)
sold by the owner, operator, or agent in charge of such farm
directly to a consumer or to a restaurant or grocery store.” [section
107(c)(4)(A)–p. 46].
For
example, vegetables grown on a farm and sold at a farmers market would
be exempt. But if that same farmer brought peaches from a neighbor’s
farm to sell at the market, the peaches would not be exempt.
IV. GROWING STANDARDS
The
FSEA will also directly impact produce farmers by authorizing FDA to
tell them how they can grow their crops. The bill would require the
HHS Secretary to establish by regulation “science-based standards for
the safe growing, harvesting, packing, sorting, transporting, and
holding of raw agricultural commodities that–(1) are from a plant or a
fungus; and (2) for which the Secretary has determined that such
standards minimize the risk of serious adverse health consequences or
death to human or animals.” [section 104(b), sec 419A(a)–p. 31]
Any
issued regulation “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.” [section 104(b), sec 419A(b)(3)–p. 32]
In
issuing the regulation, the Secretary “shall take into consideration,
consistent with ensuring enforceable public health protection, the
impact on small-scale and diversified farms, and on wildlife habitat,
conservation practices, watershed-protection efforts, and organic
production methods” [section 104(b), sec 419A(b)(7)–pp. 32-33]
Based
on the FDA’s track record with “good agricultural practices”, the
agency is unlikely to adequately address the differences between
industrial operations and sustainable farms. The danger is that FDA
will adopt regulations that treat small farms growing a diversity of
crops organically (whether certified or not) the same as a facility
growing thousands of acres of a single crop conventionally. The
regulations could be expensive and burdensome, or simply not feasible,
for small farms. Any produce that does not meet the established safety
standards would be considered adulterated under the FSEA [section
104(a)–p. 30].
Aside from produce, the
Secretary is charged with issuing “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” [section
103(b), sec 419–pp. 29-30]. Food that “has been manufactured,
processed, packed, transported, or held under conditions that do not
meet [these] standards” is considered as adulterated under the FSEA.
FDA would have the power to make pasteurization of raw milk and
irradiation of meat performance standards.
V. ENFORCEMENT POWERS
The FSEA would give FDA considerable enforcement powers. Under current law, FDA can administratively detain food if there is “credible evidence or information indicating that such article [of food] presents a threat of serious adverse health consequences or death
to human or animals” [21 USC 334(h)(1)(A)]. The FSEA would lower the
standard for detention, permitting the government to detain food
simply if there is “reason to believe that the article [of food] is adulterated, misbranded or otherwise in violation of this act” [section 132(a)–p. 82]. In other words, the agency could detain food based on a suspicion of a paperwork error.
A. RECALL POWER
The
FSEA would not only expand the ability of FDA to detain food but would
also significantly increase the agency’s recall powers. The agency
already has the power to request a voluntary recall [21 CFR 7.45(a)],
administratively detain food [21 USC 334(h)(1)(A)], or file for a court
order to seize food [21 USC 334(a)(1)] or prohibit the food from
being distributed[21 USC 332(a)].
Under the FSEA, the powers of the HHS Secretary would be expanded.
The HHS Secretary may request a voluntary
recall if there is “reason to believe [the food] is adulterated,
misbranded or otherwise in violation of [the FFDCA]” [section 111(b),
sec 420(b)–p. 61].
Under the FSEA, the Secretary also would have the power to order the distribution of food to cease if there is “reason to believe
that the use or consumption of, or exposure to, an article of food may
cause adverse health consequences to humans or animals . . . ” [section
111(b), sec 420(c)–p. 62].
The
firm affected would have 24 hours to appeal the order and request an
informal hearing [section 111(b), sec 420(d)–pp. 62-63]; after
providing an opportunity for a hearing, the Secretary could either
vacate the order or amend the order to require a recall of the food [section 111(b), sec 420(e)–p. 63].
If
there is a reasonable belief that a food subject to an order to cease
distribution “presents a threat of serious adverse health consequences
to humans or animals”, the Secretary may issue an emergency recall
order without having to conduct a hearing beforehand [section 111(b), sec 420(f)–pp. 64-65].
Although
consumer groups have urged that FDA be granted mandatory recall
authority, the “reasonable belief” standard provides too much latitude
to the agency and is open to abuse, particularly absent prior judicial
review.
B. POWER TO QUARANTINE
Finally, the bill would give FDA the power to order a quarantine of a geographic location. The FSEA provides:
“If
the Secretary determines that there is credible evidence or information
that an article of food presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary may
quarantine any geographic area within the United States where the
Secretary reasonably believes such food is located or from which such
food originated. The authority to quarantine includes prohibiting or
restricting the movement of food or of any vehicle being used or that
has been used to transport or hold such food within the geographic
area” [section 133(b)(1)–pp. 83-84].
In other words, the agency can halt the movement of all
food in a geographic area. Farmers markets and local food sources
could be shut down, even if they are not the source of the dangerous
contamination. The agency could take this drastic action without any
court order. The only requirements are that the HHS Secretary “notify
an appropriate official of the State affected” and issue a public
announcement [section 133(b)(2)–p. 84].
C. CRIMINAL & CIVIL PENALTIES
The
FSEA creates severe criminal and civil penalties. Under current law,
anyone committing a violation of the FFDCA can be imprisoned for up to
three years if the violation was committed “with the intent to defraud
or mislead” [21USC 333(a)(2)]. Under the FSEA, anyone who “knowingly
violates” certain prohibitions contained in the FFDCA, such as the
prohibition against introducing adulterated or misbranded food into
interstate commerce [21 USC 331(a)], can be imprisoned for up to ten
years [section 134(a)(3)–p. 85]. Note that such actions as failing to
register a facility or not conducting a hazard analysis constitutes
“misbranding”. So, an Amish farmer who knowingly refuses to register
his facility, or a local baker who knowingly failed to fill out the
extensive required paperwork, could be thrown in jail.
The
bill also provides fines of up to $100,000 for each violation for
individuals; and a corporation or other entity can be fined up to
$500,000 for each violation. Each day during which a violation
continues shall be considered a separate offense [section 135a–pp.
85-86]. These fines can be imposed for any prohibited act, which would
include violations of the growing standards or paperwork requirements.
In contrast, under current law, civil fines are half as high and
only levied if someone has introduced or delivered for introduction
into interstate commerce adulterated food. [21 USC 333(f)(2)(A)]
While
higher penalties may be necessary to deter industrial food companies
from repeated dangerous violations, the agency has a track record of
pursuing small farmers and producers; these penalties could be imposed
to ruin people for actions that pose no threat to human health.
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