permaculture

["Lawrence F. London, Jr." <venaurafarm@bellsouth.net>]

> As Sen. Hagan sits on both the HELP Committee, which has jurisdiction
> over S 510, and the Committee on Small Business and Entrepreneurship,
> her decision to co-sponsor Sen. Tester's amendments is a huge victory
> for us.  We owe her a huge thank you because her co-sponsorship
> means NC's voice can be the most important in the country.

S. 510 Food Safety Modernization Act

Healthy Local Foods Amendment – Sen. Jon Tester

The U.S. Senate is about to pass sweeping legislation providing Food and 
Drug Administration oversight
over local processors processing local product for local markets, and 
small, direct market food producers
offering fresh, wholesome local foods for farmers markets.

Sen. Jon Tester is offering an amendment that would remove these vital 
local food growers and
processors from federal oversight, leaving them –as they currently are – 
within the existing regulatory
framework of state and local health and sanitation laws and rules.

• All of the well-publicized incidents of contamination in recent years 
– whether in spinach,
peppers, or peanuts – occurred in industrialized food supply chains that 
span national and even
international boundaries. The food safety problems in this system can 
and should be addressed
without harming the local food systems that provide an alternative for 
consumers.

• The growing trend toward healthy, fresh, locally sourced vegetables, 
fruit, dairy, and value-added
products improves food safety by providing the opportunity for consumers 
to know their farmers
and processors, to choose products on the basis of that relationship, 
and to readily trace any
problems should they occur.

• Farmers and processors who sell directly to consumers and end users 
have a direct relationship
with their customers that ensures quality, safety, transparency and 
accountability. In addition,
small-scale food producers are already regulated by local and state 
authorities, and the potential
risk their products pose is inherently limited by their size. For these 
farmers and processors, new
federal requirements are unnecessary and would simply harm both the food 
producers and their
consumers.

Questions and Answers

Q: Why shouldn’t small Farmers Market vendors have to comply with the 
same regulations as
larger farmers who sell to Dole or Del Monte or other large food 
processors?

A: When produce is sold to large companies in a long industrial food 
chain, it is commingled with
produce from many farms and changes hands as it is distributed, 
transported, stored, and marketed across
long supply chains covering on average 1,500 miles and dozens of states. 
The commingling, processing,
storage, and transport times all increase the risk posed by these 
products, in addition to the much larger
number of people consuming such foods. In contrast, farmers market 
vendors sell small quantities of
their products directly to consumers very shortly after harvest, making 
their products lower risk.

In addition, even with the proposed exemption to S. 510, farmers market 
vendors still must comply with
the rules set forth by the market managers, state and local health 
officials. They also deal directly with
their customers, who do not have to wonder where the product they are 
purchasing came from – so there
is inherent transparency and traceability in Farmers Market transactions.

It is overreaching and inappropriate for the federal government to 
insert itself into this simple local
business transaction. Even if the worst case scenario were to unfold, in 
which a dangerous food borne
pathogen were to contaminate the product sold in a farmers market, it is 
well within the capacity of local
and state health officials to remedy the situation and address the problem.

Q: Doesn’t S. 510 provide numerous provisions to protect small 
businesses from complex,
expensive, burdensome and inappropriate regulations?

A: In Sec. 103, “Hazard Analysis and Risk-Based Preventive Controls”, 
the Secretary of Health and
Human Services may exercise flexibility when developing the rules under 
this section of the Act.
However, Sec. 103 contains a long list of highly prescriptive and 
specific requirements that contradict the
“flexibility.”

The prescriptive and mandatory steps in the Act include the following:

Identify and evaluate known or reasonably foreseeable hazards; develop a 
written analysis of the
hazards; identify and implement preventive controls; monitor the 
effectiveness of the preventive
controls; establish procedures that a facility will implement if the 
preventive controls are found to
be ineffective; verify that the preventive controls are adequate and the 
owner operator is
conducting monitoring and is making appropriate corrective actions and 
that the preventive
controls implemented are effectively and significantly minimizing or 
preventing the occurrence of
identified hazards including the use of environmental and product 
testing and that there is
documented, periodic reanalysis of the plan to ensure that it is still 
relevant; maintain for not less
than 2 years records documenting the monitoring of the preventive 
controls, instances of
nonconformance, testing results and other verification and corrective 
actions; prepare a written
plan that documents and describes the procedures used by the facility to 
comply with the
measurements of this section; and conduct a reanalysis whenever a 
significant change is made in
the activities conducted at a facility or every 3 years whichever is 
earlier.

In Sec. 105, “Standards for Produce Safety,” new FDA rules clearly apply 
to all produce sold in the
United States, including the produce marketed directly to consumers by 
small farmers and gardeners in
farmers markets. The bill’s language says that the rules “shall provide 
sufficient flexibility to be
applicable for small businesses and entities that sell directly to 
consumers and be appropriate to the scale
and diversity of the production and harvesting of such commodities.” 
This means that the FDA will be
writing rules governing the farming and harvesting practices of the 
small farms and gardeners who sell
their products in farmers markets and local restaurants featuring fresh 
local produce. Again, it is well
within the authority of local and state governments to address any 
problems that might arise from the
direct market sale of produce in farmers markets or the direct 
farm-to-school, farm-to-restaurant or farm-
to-institution programs that are increasingly being promoted and 
celebrated around the country.

In Sec. 204, there is language to allow farms covered by Sec. 105 to 
rely on their normal business records
showing immediate subsequent recipients. There is also language that 
states that the Secretary cannot
prescribe specific technologies for the maintenance of records.

Sen. Tester’s amendment is needed because it clearly defines a scale of 
production and marketing for
farms that does not have to comply with FDA farming and harvesting rules 
in Sec. 105; and for facilities
that does not have to meet the rigorous and specific, expensive and 
burdensome list mandated by Sec. 103
and the traceback and record keeping mandates of Sec. 204.

Q: Will the amendment open the doors to imports that threaten public 
health?

A: First, importers will not be able to qualify for the exemption for 
direct marketing farms because
they do not sell directly to consumers. Second, with respect to the 
exemption for small-scale processors,
the exemption only addresses Sections 103 and 204, which involve 
developing written plans and keeping

records. These paperwork requirements are not the primary or best means 
for addressing contaminated
imported food. For companies importing their products into the U.S., 
whether raw agricultural
commodities or products coming from facilities, the key public health 
protection will be the on-site
inspection and verification that the FDA can bring to bear on the 
facilities and farmers in other countries.
For that reason, bringing thousands of small U.S. farms and small local 
facilities under FDA’s jurisdiction
is counter productive because it diverts scarce public resources away 
from facilities and farms in other
countries that should be inspected to ensure public health.

Q: What is a facility?

A: In the Bioterrorism Act of 2002, Congress amended the Food, Drug and 
Cosmetics Act to broadly
define a food “facility” with the objective of registering every food 
processor, domestic or foreign, that
sells its product in the U.S. regardless of size, for national security 
purposes. S. 510 uses that same
definition of “facility” for a completely different purpose.

Pursuant to the Bioterrorism Act, FDA adopted guidance on what is and is 
not a facility. The exceptions
include:

• Farms are not facilities, unless they are adding value to their 
produce, in which case they are
facilities.

• Residences are not facilities. (Most state public health laws do not 
permit the commercial sale of
products from home kitchens, however.)

• Retail food establishments are not facilities. The guidance around 
this exemption appears
designed to establish that bakeries, delicatessens, and restaurants do 
not fall under the Food Drug
and Cosmetics Act. The House bill incorporates part of that guidance 
into the statute.

There appears to be several misconceptions about what constitutes a 
facility. Some people have
incorrectly stated that a farm that sells its value added products 
directly is exempt; however, the FDA’s
guidance specifically states that the value-added products are only 
exempt if they are consumed on the
farm. If the farmer leaves the farm and sells the jam or jelly at a 
farmers market, then his or her operation
is deemed a facility.

In the period since the Bioterrorism Act was adopted in 2002, thousands 
of facilities have registered, but
there are still thousands more who have not yet complied. In July 2009, 
the FDA reported the number of
facilities registered by state and by country. (See
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/ucm175995.htm 


All of these small businesses, many of them very tiny, will now be the 
targets of the FDA and responsible
for the rigorous and expensive requirements of Sec. 103 and 204 of the 
Act. In the House-passed version
of the Food Safety Enhancement Act (H.R. 2749) every one of these 
facilities will need to pay a $500
annual registration fee to underwrite the enforcement of this sweeping 
new law.

Prepared by:

Margie MacDonald Judith McGeary

Western Organization of Resource Councils Farm and Ranch Freedom Alliance

406.252.9672 512.243.9404

mmacdonald@worc.org jmcgeary@att.net