Food Protection Trends - July/August 2019 - 341

Sanitation Program (NSSP), meets biennially to update mandates and guidance for the Model Ordinance. Unlike agencies
involved with most other foods under FDA's purview, in
which the agency is authorized to develop food safety regulations, the NSSP is a cooperative program between Federal
Agencies including FDA, National Oceanic and Atmospheric
Administration (NOAA), Environmental Protection Administration and CDC, state control authorities and industry.
Vibrio policy has dominated the ISSC debate since the late
1980s. The debate has been contentious, often pitting region
against region, especially with regard to Vv when illnesses
were traced exclusively to the Gulf region. An FDA proposal
to ban harvest of Gulf oysters from May through October was
narrowly defeated in the 1990s. This was followed by a plan
in 2000 to reduce the Vv illness rate by 60% over a 7-year period. Educating high-risk consumers and increasing post-harvest processing (PHP) capacity were the key elements of this
plan. Soon after the Vv illness reduction plan was adopted,
California passed a bill to prohibit importation of Gulf
oysters from May through October unless they had undergone a PHP to reduce Vv most probable number (MPN) to
< 3 per gram. The ISSC censored California for this action,
and CA lost its voting privilege even though the policy was
effective in preventing Vv illnesses in CA (51). However, the
ISSC Vv illness reduction plan failed to meet the 60% illness
reduction goal. The industry and states requested that FDA
develop a Vv risk calculator for scenario analysis of proposed
refrigeration controls for Vv risk reduction. FDA produced
a Vv risk calculator based on the VVRA (23). Calculator
inputs were monthly average water and air temperatures, time
between harvest and refrigeration, and time to cool to 13°C
(55°F), the minimum Vv growth temperature, after the start
of refrigeration. The output was risk per 100,000 servings,
and the goal was to reduce risk from five illnesses to two per
100,000 meals. A new regime that came to FDA after the
2008 presidential election attempted to mandate PHP of
Gulf oysters during the Vv season, based on Hazard Analysis
Critical Control Point (HACCP) rules, an action that united
nearly all parties at ISSC to defeat this unilateral FDA action.
Gulf harvesters complained that they had invested heavily in
refrigerated harvest vessels in anticipation of a rapid cooling
mandate. The conference adopted a Vv control plan based on
the FDA Vv risk calculator that went into effect in 2010. FDA
was heavily criticized in the press and admonished by the
Gulf congressional delegation for overreaching its authority.
Although FDA officially maintained its position for mandatory PHP, a provision was included in the Food Safety Modernization Act (FSMA) to prevent unilateral action by FDA to
mandate PHP of oysters for Vv control.
Just as the Vv risk season began in 2010, the largest
manmade environmental disaster in history, the Deep-Water
Horizon Oil Spill, occurred in the Gulf. Virtually all state
and regulatory oversight was appropriately focused on the oil
spill, which threatened coastal areas in all Gulf states. Florida

lifted conservation bag limits in Apalachicola Bay, fearing
that the oil would wipe out the crop. Compliance to the new
cold chain mandates were largely ignored by state authorities
at a time when FDA was also occupied by the oil spill and
still clinging to mandatory PHP as their Vv policy. The result
was a near-record number of Vv illnesses in 2010, which
remained well above the VVRA baseline annual average
of 32 through 2012. FDA influence at ISSC continued to
diminish, reaching a low point at the time of the San Antonio,
TX biennial meeting in January 2014. FDA had introduced
a number of Vibrio control proposals in 2013 after the worst
Vibrio season on record; none were adopted. Most notable
was a proposal for immediate cooling (50°F within an hour
of harvest) of oysters during the Vibrio risk season. FDA
substituted a proposal to study effects of immediate cooling,
as no states were supporting the immediate cooling mandate.
MANAGING AND MITIGATING VIbRIOSIS RISK:
CHALLENGERS AND OppORTUNITIES
Vibrios will come after you
Vibrios present unique food safety challenges. They are
ubiquitous to aquatic foods and proliferate faster than any
other pathogen. Vibrios are constantly evolving, creating
more resilient and virulent strains. They cross oceans on
ships in ballast waters and likely in biofouling communities,
on ship hulls and cause pandemics unlike any other major
foodborne pathogen. Global warming is expanding their
geographical and seasonal range and creating the greatest
Vp threat at the invasion frontier. These changes have been
stimulated by misuse of antibiotics, fossil fuel dependence
and globalization, and will likely continue to increase the
vibriosis threat for the foreseeable future. Shellfish growing
areas in higher latitudes such as in Europe that have rarely
been associated with vibriosis may be a climate anomaly
away from a major outbreak and could become the vibriosis
epicenter in a warmer world. The oyster industry has no
control over the forces of nature and globalization and should
focus on adapting and preparing for an increasingly Vibriofriendly environment.
Game changer
Sometimes things have to get worse before they get better,
as happened in 2012, when the Pacific outbreak Vp strain
(O4:K12 serotype/Sequence type 36) invaded Oyster Bay,
NY (32). Reported illnesses increased by more than an
order of magnitude, causing extended closure of areas in
Long Island Sound, including major areas in Connecticut
(CT). In 2013, this outbreak strain spread from Virginia
(VA) to Massachusetts (MA) and caused over 100 reported
illnesses (6) leading to unprecedented closures and recalls.
The industry perceived this as an existential threat and
became more receptive to controls that could restore summer
operation, which is critical to their half-shell business model.
CT control authorities responded by proposing a mandate

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