FDA Food Safety Modernization Act
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Transcript FDA Food Safety Modernization Act
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
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
(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
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