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The Impact of FSMA Rules on Sustainable Agriculture and Local Food SystemsRoland 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 processActive in developing comments on FSMA proposed
rules on behalf of sustainable agProvides food safety training tailored to diversified
and organic farms
The Real Public Health Crisis
Annual Deaths from Diet-Related DiseasesHeart disease: 806,156Diabetes: 231,402Colon/rectal cancer: 54,433
Use of Conventional Pesticides IncreasingAs much as 93% of Americans have chlorpyrifo
residuesImplicated in diabetes, ADHD, birth defects, cancers
Overuse of synthetic fertilizers, pesticides contaminating aquifers, fisheries, estuaries, etc.
Processing a Higher Risk99% of outbreaks in leafy greens between 1999 and 2007 were from bagged, ready-to-eat productsCutting leafy greens post-harvest vastly multiplies pathogen growth riskShelf-life-extending packaging (clamshells) can promote pathogen growthComingling product from large number of farms makes entire product batch vulnerable to safety lapse
New FDA PowersFDA 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 regsFDA 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 standardsPreventive controls in food processing ‘facilities’Preventive controls in manufacture of animal feedPrevention of intentional contaminationSanitary transportationForeign 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 businessProduce 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 forLocal 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 forLocal 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 testingNo 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 ProgramMore 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 compostIgnores evidence of effectiveness of biological soil
amendments in controlling pathogensIncreased use of synthetic fertilizers
How Did FDA Do?
Local food businesses at competitive disadvantageFarms treated as ‘facilities’Small food processors sell 4% of food, will bear 73% of
compliance costsFDA acknowledges wide variety of ‘processing’ activities are
low risk, but regulates them as high risk anywayIf 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 processStatutory protections can be withdrawn for almost any
reasonNo opportunity to reinstate those protections if it turns out
FDA was wrong, or any problem is correctedAll 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 eitherPreamble 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 practicesPrivate standards and some buyers likely to continue to
pressure farms to remove habitat, buffers
Agriculture United for the First Time EverNational Association of State Depts. of Agriculture calls for ‘do over’ on proposed rulesProduce industry outcry from large and small entities alikeBelated Environmental Impact Statement
Roland McReynoldsExecutive DirectorCarolina Farm Stewardship AssociationPO Box 448Pittsboro, NC 27312(919) 542 2402roland@carolinafarmstewards.orgwww.carolinafarmstewards.org
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