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