The Impact of FSMA Rules on Sustainable Agriculture

The Impact of FSMA Rules on Sustainable Agriculture and Local Food Systems Roland Mc. Reynolds, 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 Mc. Reynolds Executive Director Carolina Farm Stewardship Association PO Box 448 Pittsboro, NC 27312 (919) 542 2402 roland@carolinafarmstewards. org www. carolinafarmstewards. org