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
 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
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
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
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
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
written food safety plan
hazard analysis
food safety plan monitoring
corrective actions
validation of plan
periodic reanalysis and revision of plan
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
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
 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
 Belated Environmental Impact Statement
Roland McReynolds
Executive Director
Carolina Farm Stewardship Association
PO Box 448
Pittsboro, NC 27312
(919) 542 2402
[email protected]

FDA Food Safety Modernization Act