Biomedical Engineering Reference
In-Depth Information
Some studies have reported that free nanoparticles can cross cellular barriers and
that exposure to some of these nanoparticles may lead to oxidative damage and
infl ammatory reactions (Chaudhry et al.
2008
; Bouwmeester et al.
2009
).
12.3.4
Regulations
Until recently, most systems for regulating food safety were based on legal defi ni-
tions of unsafe food, enforcement of programs to remove the unsafe food from the
market, and sanctions for the responsible parties. These traditional systems cannot
respond to existing and emerging challenges to food safety because they do not
provide or stimulate a preventive approach. In the past, there was a transition to risk
analysis based on better scientifi c knowledge of food borne illness and its causes.
This provides a preventive base for regulatory measures for food safety at both
national and international levels. The risk-based approach must be supported by
information on the most appropriate and effective means to control food borne haz-
ards (Rosegrant and Cline
2003
).
All these changes lead to situations in which a single source of contamination
can widespread, even with global consequences. Developing countries in particular
are experiencing rapid changes in their health and social environments, and the
strains on their limited resources are complicated by expanding urbanization,
increasing dependence on stored foods and insuffi cient access to clean water and
facilities for safe food preparation (WHO
2002
).
The FDA FSMA (Food Safety Modernization Act) sections include the preventive
control plans where the food manufacturing facilities must develop and implement
written science-based plans that evaluate hazards that could affect food safety. In addi-
tion, the mandatory states safety standards created by the FDA and establishes science-
based minimum standards for the correct production and harvesting of horticultural
products. The mandatory inspections of food facilities are based on risk, and all high-
risk domestic facilities must be inspected within 5 years of enactment and no less than
3 years thereafter. FDA is required to establish a comprehensive product tracing system
to track movement of food products from farm to point of sale or service. The goal is
to identify sources of food borne illnesses earlier and contain outbreaks more quickly.
To assure the quality and security of food, there is a third-party certifi cation
where designated imported foods must be certifi ed by a third party with expertise in
food safety under the oversight of FDA. At the same time, a certifi cation is necessary
for high-risk food because FDA requires that high-risk imported foods have to be
accompanied by a credible third-party certifi cation or other assurance of compli-
ance as a condition to get into the U.S. In case of any problem, the process named
mandatory recall requires a recall from authorities based on a “reasonable probabil-
ity” that an article of food is adulterated, misbranded or will cause “serious adverse
health consequences or death” to people or animals, and fi nally the suspension of
registration if it is determined that the food has a reasonable probability of serious
adverse health consequences or death. A facility that is under suspension is prohib-
ited from distributing food (Ades et al.
2012
).
