integrating stakeholder roles in food production, marketing and safety systems: an evolving,...
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Integrating Stakeholder Roles in Food Production, Marketing and Safety Systems: An Evolving, Multi-Jurisdictional ApproachA. Bryan Endres & Nicholas Johnson
University of Oregon School of LawCultivating our Future: New Landscapes in
Agricultural Law and PolicyOct. 1, 2010
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Agricultural Production Context
• Declining # of farms– Defining a “farm” is difficult
• Increasing size/intensity of remaining farms• Agriculture remains primary economic driver in
rural communities• Jeffersonian ideal of citizen-farmer long past• Disconnect between consumers and producers
– “Old McDonald’s Farm” is now “The Meatrix” or “Food, Inc.”
– Environmental Working Group’s publication of subsidies– USDA’s “Know your Farmer, Know your Food” program
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Corn & Soybean Production
Corn = 27.9% of harvested croplandSoy = 20.6% of harvested cropland
Source: USDA 2007 Census of Agriculture
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Declining # of Animal Producers
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Intensification of Milk Production
13% production increase38% decrease in number of dairy farms
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Egg Production by State
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 20090
2000
4000
6000
8000
10000
12000
14000
16000
CaliforniaIndianaIowaMaineOhioPennsylvania
Mill
ions
of
Egg
s
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Regulatory Paradigm
• What is the role of government in supporting/regulating an industry that:– Involves fewer members of society– Increasing is larger in scale/intensity– Provides essential sustenance to our nation and abroad– Remains primary driver of rural society
• Specifically, what is the role of government in preventing food borne illness/food safety?
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Ad Hoc, Historical, Food Safety System
• 1820 U.S. House Ag Cmte• 1825 Senate Ag Cmte• 1862 USDA established• 1862 Land-Grant Univ.• 1887 Hatch Act (experiment
station)• 1906 Meat Inspection Act• 1906 Food & Drug Act• 1914 Smith-Lever (extension)• 1927 USDA Bureau of Chemistry
reorganized to Food , Drug and Insecticide Administration
• 1933 Ag Adjustment Act
• 1938 Food, Drug & Cosmetic Act• 1940 FDA transferred from USDA
to Federal Security Agency (now Dept. Health and Human Services)
• 1940s-1970s Period of Ag Intensification
– Technology– Capital Investment
• Focus on yield and commodities
• 1970s Environmental Quality Improvement Act & others
• 1970 Egg Products Inspection Act• 1990 Organic Foods Production
Act
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USDA
Production• Quantity• Quality• Rural Economies
Food Safety
Environ-ment
“Get Big or Get Out,” Earl Butz, Secretary, USDA 1971-1976
“AMS is not a Food Safety Agency,” Rayne Pegg, Administrator, USDA, AMS Administrator, Testimony to Congress (July 29, 2009)
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FDA
Safety Production• Live
animal intended for food
FDA’s primary mission is consumer protection
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FDA: Quality as an element of Safety?
Safety
Quality- §342(a)(3) “…otherwise unfit for food”
Will consider later within context of Marketing Agreements . . .
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Multi-Dimensional Food Supply Chain
Graphic Source: Proceedings of the Frontis Workshop on Quantifying the agri-food supply chain, Wageningen, The Netherlands, 22-24 October 2004
• In an increasingly industrialized, centralized and concentrated food production system, it is critical to prevent foodborne illnesses at an early stage in the integrated supply chain
• Often the most effective place for regulation is at the farm level
• FDA lacks jurisdiction over most non-animal farm-level operations
Production(USDA)
Safety(FDA)
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Complicated System of Multi-Agency Oversight
Source: GAO: US Needs a Single Agency to Administer a Unified, Risk-Based Inspection System (1999)
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Two Recent Examples of Food Safety Failures in a Multi-Agency Jurisdictional
Environment• Fresh-Cut Leafy Greens
– Potential Pathogen: E. Coli & Salmonella– Most Recent Major Outbreak: 2006 (Spinach)– Significant problem since: 1990s– Proposed Solution: Nat’l Leafy Greens Marketing
Agreement
• Shell Eggs (discussed in paper)– Potential Pathogen: Salmonella– Most Recent Major Outbreak: Summer 2010– Significant Problem Since: 1986– Proposed Solution: Salmonella Eradication Program ( 21
C.F. R. part 118)
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The Leafy Greens Industry
• What are leafy greens? – Broadly defined, but typically includes lettuce (79% of
market), cabbage (15%), and spinach (7%); “whole head” and “fresh-cut”
• Industry members – Growers – Handlers (harvest/pack raw greens in the field) – Processors (receive, clean, cut, & package raw greens for
retail) – Retailers (grocers)
• Large growth in “fresh-cut” (bagged/“ready to eat”)– Packaged sales now represent 50% of the market
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Fresh Cut Leafy Green Retail Sales 1985-2005
1985 1994 1999 2003 2005
Retail $6B
Food Service $9B
Total Sales $0 $3.3B $6.0B $8.9B $15B
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Leafy Greens Production, 1999-2008 (billions of pounds)
1999 2000 2001 2002 2003 2004 2005 2006 2007 20080
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2
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CabbageHead LettuceLeaf and Romaine Spinach
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Fresh-Cut Market Dominance by Brand, 2006
Fresh Express (Chiquita) 41%
Dole 31%
Ready Pac 8%
Earthbound Farms (Natural Selection Foods) 6%
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The Problem
• Bacterial outbreaks in leafy greens have been occurring with increasing frequency: – from 1996 through 2006, there were at least 96
outbreaks, 10,253 illnesses, and 14 deaths associated with the consumption of fresh produce (FDA data)
– Since 1999, there have been 12 outbreaks of E. coli traced back to leafy greens (FDA data)
– 2006 E. coli outbreak in bagged spinach resulted in 3 deaths and more than 100 hospitalized
– Estimated financial loss to leafy greens industry due to spinach outbreak: $37M - $74M
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Federal Regulation of Leafy Greens
• There is no universal on-farm food safety protocol for leafy greens.
• FDA oversight– FDA is charged with promoting safety of leafy greens under FFDCA, but has no
formal fresh produce safety program in place– Spending on fresh produce safety accounted for only 3% of FDA total allocated
spending in 2006-07– FDA’s job has become harder/more complex with rise of global fresh-cut produce
industry (larger production volume; longer national supply chains)
• Guidance Documents – In 1998, FDA and USDA published a document that provides guidance to industry
by outlining Good Agricultural Practices (GAPs) to minimize microbial contamination in fruits and vegetables
– Provides “best practices” guidance on water quality, manure management, worker hygiene, field and facility sanitation, transportation, etc.
– Compliance is completely voluntary (though farmers may participate in more stringent audit process)
– Does not specifically address leafy greens – Based on science that is now more than 10 years old (FDA currently revising
through a notice and comment process)
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Private Regulation of Leafy Greens
• Absence of federal standards, plus recent microbial outbreaks (financial loss), have led to industry self-regulation of leafy greens – Private “super-metrics”
• Food Safety Leadership Council– Disney, Wal-Mart, McDonald’s, Darden, Publix
– Marketing Agreements• State• Federal
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Marketing Agreements
• Agreement among industry players (growers, handlers, processors) to establish “best practice” metrics
• Approved by state or federal regulatory body • Voluntary opt-in, but metrics binding upon signatories• E.g., California Leafy Greens Marketing Agreement (CLGMA):
– Agreement between 120 leafy greens handlers (99% of CA production).
– Best practices in five major categories of risk (growing environment, soil amendments, water, worker practices, & field sanitation)
– Enforced by audits conducted by California Dept. of Ag. – Though the agreement is signed by handlers, it also affects growers:
• Many compliance requirements implemented at field level• Signatory handlers may not source greens from a grower not in compliance
with the CA LGMA.
– Similar agreement is in place in AZ; the two agreements cover approx. 90% of all leafy greens grown in U.S.
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National Leafy Greens Marketing Agreement
• Goal: Create one, national, uniform standard for measuring the safety of all leafy greens – Replicates CA agreement on a national scale. – NLGMA can be used to “push back on and help extinguish the
diverse market driven specifications and independent audits that plague growers and handlers across the country.”
• How the national marketing agreement process works: – Proponent group petitions Secretary to enter into marketing
agreement – Secretary holds “notice and comment” proceedings on the
record– Secretary enters into marketing agreement with industry group
if it “effectuates the declared policy” of the AMAA – Agreement Committee promulgates audit metrics – Agreement provisions binding on signatories
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Agricultural Marketing Agreement Act of 1937 (7 U.S.C. § 601)
• Purpose: Control supply-demand; Farm-gate prices
• Based on Agricultural Adjustment Act of 1933– Constitutionality questioned; U.S. v. Butler, 297 U.S. 1
(1936)– “Marketing agreements . . . assure producers a fair
return without the necessity for the processing tax...” Henry Wallace, Sec. USDA, testimony to Congress
• House Report No. 6 (accompanying ’33 Act)– “such agreement may be entered into only for the
purpose of effectuating the declared policy of gradually establishing and maintaining such balance between production and consumption as will reestablish for agricultural commodities their pre-war purchasing power”
– “seeks to increase the purchasing power of our farmers”
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Marketing Agreements, Food Safety & Governance
• “AMS is not a food safety agency”• AMS oversees “quality”
– Is “safety” an element of “quality”?
• Role of private actors in determining standards– Consumer; Producer input– Post-agreement standard modifications
• Technically voluntary; Commercially compulsory• Accountability of Agreement Committee?
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Larger Governance Issues
• Fractured federal system• Some state action (LG), but race to bottom
concerns (Eggs)• Industry initiatives and micro-standards• Industry-Government cooperation • Structures to accommodate scale;
globalism• Consumer consciousness and involvement
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USDA
Shift internal priorities; grading used to assess quality, safety
and environmental impact
Shift agency jurisdiction
Production
Environment
USDA FDA
SafetyFarm-to-Fork
Current reform proposals?
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Structure of the NLGMA
• “Handlers” may be party to the agreement– Handler = those who “receive, acquire, sell, process, ship, distribute or import leafy greens”. Retailers
NOT included. • Administrative Committee
– “Governing body” of the NLGMA. • Made up of 23 members, who are industry handlers, producers, retailers, & importers. One seat
for a member of the public. • Has power to create operational rules and regulations, adopt metrics (after notice and comment),
receive and investigate complaints, recommend amendments and collaborate with state entities.• Technical Review Board: Reports to Committee; charged with developing program metrics (GAPs
and GMPs) that will be recommended to USDA. • Market Review Board: Reports to Committee; is to report on retail, food service, and consumer
issues that should be addressed to maximize consumer confidence in leafy greens• Inspections and audits:
– all signatories to the Agreement agree to audits (both scheduled and unannounced) by USDA inspectors to ensure compliance with GAP metrics.
• Audit metrics: – The Committee and its technical board will develop and recommend to USDA Good Agricultural
Practices (GAPs) metrics that address water quality, soil amendments, machine harvest, hand harvest, transfer of pathogens by workers, field sanitation, cross contamination through equipment, et. al.
– Audit metrics will also include traceback provisions • Certification mark
– Those in compliance with the terms of the Agreement may use a certification mark on their products.
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NLGMA Structure – Enforcement Provisions
By the agreement’s terms, any lot of leafy greens determined to be an “immediate threat to public health” as determined by Inspection Services will be reported to FDA.
Generally, a signatory “may be subject to withdrawal of audit services, loses the privilege of using the service mark, and may be subject to misbranding or trademark violations” if: it produces or acquires leafy greens without first obtaining
an audit. It ships leafy greens that have not been audited. It commingles unverified leafy greens with verified ones. It refuses to provide access to books and records.
• The agreement states that failure to comply with its terms may result in additional penalties, including injunctive relief.
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NLGMA – Pros
• The NLGMA will create a single national, verifiable inspection process for leafy greens, thereby reducing the need for onerous and overlapping “super-metrics.”
• The agreement will provide metrics that are more rigorous than current advisory guidance and that are specific to leafy greens.
• The agreement will restore consumer confidence in leafy greens, thereby increasing their marketing viability.
• Unlike government regulation, the agreement’s flexible structure allows the metrics to change as quickly as food safety science does.
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NLGMA – Cons
• A vocal minority of leafy greens growers and handlers (many of whom are small and/or organic growers) oppose the proposal. Their concerns: – USDA isn’t a food safety agency, and food safety isn’t a
marketing issue. – The agreement is voluntary in name only. – The NLGMA won’t get rid of overlapping leafy greens
regulations, including “super-metrics.” – The agreement will have an adverse impact upon the
environment. – The agreement will be prohibitively expensive for small growers
to comply with .– The agreement’s “one-size-fits-all” metrics won’t account for
regional growing variations – The agreement won’t make leafy greens any safer.
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Government Oversight in a Private Agreement
• Key touchpoints between industry regulation and government regulation in the NLGMA: – Secretary of Agriculture signs off on marketing
agreement and can terminate it at any time. – Audits are conducted by USDA inspectors and
incorporate USDA/FDA guidance on GAPs, GHPs, and GMPs.
– Per USDA/FDA Memorandum of Understanding, AMS must:
• Supply FDA lists of all facilities under continuous AMS inspection
• Investigate any report by FDA that a facility under AMS contract has not corrected “objectionable conditions” found by FDA
• “immediately advise” FDA of facilities “subject to withdrawal or suspension of service [by AMS]… because of sanitation or other current good manufacturing practice deficiencies.”
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Egg Production