a potential health risk existed. It would be difficult not to conclude
that many importers treated refusals and recalls as part of the cost of
doing business.
Until very recently, FDA has never had sufficient resources to con-
duct a meaningful number of foreign inspections, and the agency had
to request permission to conduct the inspection from the foreign gov-
ernment and the firm to be inspected. The foreign firms FDA wanted
Americans consume foods im-
ported from over 150 countries. A
total of 15 percent of U.S. food is
imported, with higher percentages
for certain commodities: 75 percent
of seafood, 20 percent of vegetables
and 50 percent of fruit is imported.
“W“When it comes to justifying the passage of the new law, the FDA points to the 48
million illnesses, 128,000 hospitalizations and 3,000
deaths attributed to food each year.”
to visit rarely refused inspection explicitly. Usually, the answer from
the firm was, “Yes, but not now, we’re closed for the holiday, season,
month, etc.”
The State of Food Safety Today
When it comes to justifying the passage of the new law, the FDA
points to the 48 million illnesses, 128,000 hospitalizations and 3,000
deaths attributed to food each year. Foodborne illness can be catastrophic to immune-compromised individuals, a growing segment of
our population. It can cause lifelong disease and disability, including
arthritis and kidney failure. Although these numbers have remained
fairly constant for several years, high-profile outbreaks here and
abroad attributed to imported and domestic foods have raised the
issue in the minds of most Americans. Imported vegetable protein
contaminated with melamine killed many American pets, and milk
contaminated with melamine killed and injured children in China.
Peppers, eggs, peanut butter, pistachios, spinach, cookie dough,
sprouts and cantaloupes have all been associated with recent disease
outbreaks. Many of the outbreaks in the U.S. were associated with imported foods or food ingredients. Allergen contamination leads to
many recalls but is rarely in the press.
An outbreak and subsequent recall such as the recent one involving cantaloupes is a huge drain on FDA’s limited staff. All of the available resources of the District Offices and the Center for Food Safety
and Applied Nutrition are diverted to managing the problem. In most
large outbreaks, widespread distribution networks require the involvement of many of the agency’s District Offices in locating the product,
collecting and analyzing samples and monitoring the recall. It is totally
understandable that FDA needs to move to a more preventive mode
and away from a reaction mode. That’s not to say that outbreaks will
go away, but a worthy goal is to make them less frequent and more
manageable.
The New Rules
With the passage of the FSMA,
FDA has new tools to ensure imported foods meet U.S. food safety
standards. Under the new Section
419, “Standards For Produce Safety”
of the Federal Food Drug and Cosmetic Act, the secretary of health and
human services (in coordination with
the secretary of agriculture and state
departments of agriculture, including
the National Organic Program) shall
publish a notice of proposed rule-making to establish science-based
minimum standards for the safe production and harvesting of raw agricultural commodities to minimize the
risk of serious adverse health consequences or death.
One of the main provisions of the
new law is to help ensure that food
from abroad is as safe as food produced domestically. For the first time,
importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety.
FDA will also be able to accredit qualified third-party auditors to certify that
foreign food facilities are in compliance with U.S. food safety standards.
The new law includes specific provisions for allergens, increased inspections here and abroad, biennial
registration, certification for certain
commodity/producer combinations,
inspection frequency based on risk,
enhanced recall and detention authority and suspension of registration.
The new rules also include increased
importer accountability, third-party
certification for high-risk foods, additional manpower and resources directed toward foreign inspections and
the authority to refuse entry into the
