Roland McReynolds, Esq.
Carolina Farm Stewardship Association
About CFSA
 Member-based, farmer-driven non-profit with a
mission to advocate, educate, and build the systems to
support a sustainable food system in the Carolinas
centered on local and organic agriculture
 Heavily engaged in FSMA legislative process
 Active in developing comments on FSMA proposed
rules on behalf of sustainable ag
 Provides food safety training tailored to diversified and
organic farms
The Real Public Health Crisis
 Annual Deaths from Diet-Related Diseases
 Heart disease: 806,156
 Diabetes: 231,402
 Colon/rectal cancer: 54,433
 Use of Conventional Pesticides Increasing
 As much as 93% of Americans have chlorpyrifo
residues
 Implicated in diabetes, ADHD, birth defects, cancers
 Overuse of synthetic fertilizers, pesticides
contaminating aquifers, fisheries, estuaries, etc.
Processing a Higher Risk
 99% of outbreaks in leafy greens between 1999 and
2007 were from bagged, ready-to-eat products
 Cutting leafy greens post-harvest vastly multiplies
pathogen growth risk
 Shelf-life-extending packaging (clamshells) can
promote pathogen growth
 Comingling product from large number of farms makes
entire product batch vulnerable to safety lapse
New FDA Powers
 FDA can order a recall of food.
 FDA can detain food if there is a “reason to believe” the
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food is not produced in accordance with safety regs
FDA has the power to suspend the operations of any food
facility if there is a reasonable probability of causing serious
adverse health consequences or
FDA can require safety certification for imported food to be
certified
FDA must review health data every 2 years and issue
guidance documents or regulations to address the most
significant foodborne contaminants
FDA is required to establish a product tracing system
FSMA: One Statute,
Many Regulations
 Produce safety standards
 Preventive controls in food processing ‘facilities’
 Preventive controls in manufacture of animal feed
 Prevention of intentional contamination
 Sanitary transportation
 Foreign supplier verification
FSMA Rules Timeline
 Legislative deadline for implementing final produce
safety and facility preventive controls rules would have
been 2013
 Proposed produce and facilities rules published in
2013; comment period closed Nov. 22
 Northern District of CA judge has set June. 2015 as
final deadline for all FSMA rules
 FDA has already stated it will republish at least parts of
produce and facilities proposed rules for further public
comment
FSMA Rules Timeline, cont’d
 Staggered timelines for application of both rules,
based on size of business
 Produce Rule: Large farms (>$500,000) subject to
compliance 2 years after final rule publication;
Small farms (<$500,000) get 3 year phase-in;
Very Small (<$250,000) farms get 4 years
 Facilities Rule: Large firms get 1 year;
Small get 3 years; Very Small get 4 years
Proposed Produce Rule
 Key standards:
 Personnel qualifications/Worker health and hygiene training
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(SUBPART C & D)
Water (SUBPART E)
Animal-derived soil amendments (SUBPART F)
Animals (wildlife and domestic) (SUBPART I)
Facilities and food contact surfaces (equipment, tools,
instruments and controls, transport) (SUBPART L)
 Plus additional, special rules for sprouts
Proposed Facilities Rule
 Key standards:
 Good Manufacturing Practices: Updates existing GMP regulations in
21 CFR 110
 Hazard Analysis and Risk-Based Preventive Controls: Requires
every food facility to have
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written food safety plan
hazard analysis
food safety plan monitoring
corrective actions
validation of plan
periodic reanalysis and revision of plan
documentation
Congressional Protections for
Local Food, Conservation
 Scale appropriate regulations and options for small
and mid-sized farms serving local and regional markets
(Tester-Hagan Amendment)
 Ensure protection of beneficial on-farm conservation
and wildlife practices
 Complement – not contradict – National Organic
Program regulations
Congressional Protections for
Local Food, Conservation, cont’d
 Minimize extra regulations for low-risk processing that
is part of value-added production
 Streamline and reduce unnecessary paperwork for
farmers and small processors
 Allow farm identity preserved marketing as an option
in place of government trace-back controls
 Funding for training through new competitive grants
program
How Did FDA Do?
 Ag water subjected to EPA recreational water quality
standards, weekly testing
 No approved treatment for irrigation water that exceeds EPA
recreational water standards; but treating water gets farm
out of testing requirement
 No scientific basis for applying EPA recreational water
standard to irrigation water
 Far more stringent threshold than World Health Organization
irrigation water standards
 No analysis of what surface waters meet this standard
How Did FDA Do?
 Compost and manure fertilizer subject to more
stringent rules than National Organic Program
 More than doubles the length of ‘withdrawal’ period
between application of manure and harvest of produce
allowed under NOP—longer than the growing season in
most parts of the country
 No scientific basis for limitations on use of compost
 Ignores evidence of effectiveness of biological soil
amendments in controlling pathogens
 Increased use of synthetic fertilizers
How Did FDA Do?
 Local food businesses at competitive disadvantage
 Farms treated as ‘facilities’
 Small food processors sell 4% of food, will bear 73% of
compliance costs
 FDA acknowledges wide variety of ‘processing’ activities are
low risk, but regulates them as high risk anyway
 If large facilities are already in compliance, what does that
say about whether these standards will enhance prevention
of foodborne illness outbreaks?
How Did FDA Do?
 Small farms and businesses denied due process
 Statutory protections can be withdrawn for almost any
reason
 No opportunity to reinstate those protections if it turns out
FDA was wrong, or any problem is corrected
 All a farm’s product sales count toward whether farm is
protected or not, even sales of products that aren’t actually
regulated by FDA
How Did FDA Do?
 Wildlife habitat not targeted by the rules, but not
promoted by them either
 Preamble language acknowledges that habitat and
vegetation around fields does not need to be removed, and
may even support food safety
 But statutory language doesn’t encourage those practices
 Private standards and some buyers likely to continue to
pressure farms to remove habitat, buffers
Agriculture United for the
First Time Ever
 National Association of State Depts. of Agriculture calls
for ‘do over’ on proposed rules
 Produce industry outcry from large and small entities
alike
 Belated Environmental Impact Statement
Roland McReynolds
Executive Director
Carolina Farm Stewardship Association
PO Box 448
Pittsboro, NC 27312
(919) 542 2402
[email protected]
www.carolinafarmstewards.org
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FDA Food Safety Modernization Act