Agriculture Reference
In-Depth Information
laboratories need to be able to achieve for detection and identi
cation of non-
authorized substances (e.g., substances for which the legal tolerance in principle is
zero). For instance, MRPL values have been established for chloramphenicol,
medroxyprogesterone acetate, malachite green, and nitrofurans by Decision 2002/
657/EC [30]. The
first MRPL list was published in Annex II of Commission Decision
2003/181/EC [31], and the most recent modi
cation was set in the Decision of the
Commission 2004/25/CE [32].
On the other hand, the principle of zero tolerance was established by the EU for
certain residues of veterinary medical products in foodstuffs. Zero tolerance is applied
to all substances that are either not approved or whose use is explicitly prohibited,
such as Group A substances.
Apart from the EU, legislation and regulations have been established regarding
human health, food safety, and environmental protection in different countries.
For instance, in the U.S., tolerances for VDs/GPAs in foodstuffs can be found in
the Code of Federal Regulations, namely, Title 21 (Food and Drugs, 556) [33], and
these values are different from those established by the EU. Therefore, for some
VDs, MRLs are comparable (e.g., the tolerance for tylosin in chicken is set at
0.2mg/kg in the U.S., whereas it has been set at 0.1mg/kg in the EU), whereas for
other substances, differences are considerably large (e.g., the tolerance for the sum
of tetracycline residues is set at 2mg/kg in calves, swine, sheep, chicken, and
turkeysintheU.S ,whereastheMRLissetat0.1mg/kgintheEU).The
differences are due to the fundamentally different ways the limits are assigned
in the U.S. compared with the international standard protocol. The U.S. assigns the
entire acceptable daily intake (ADI) to the single edible tissue in the species for
which the drug use is sought. All other countries assign the ADI across a basket of
foods as set out by the Joint FAO/WHO Expert Committee on Food Additives
(JECFA).
The Canadian Food and Drug Regulations indicate that all VDs must be authorized
by Health Canada prior to their sale and administration to prevent and treat diseases
in animals. This department consults on the development of these laws with the
Canadian public industry, nongovernmental organizations (NGOs), and other inter-
ested organizations, and MRLs for VD residues in food have also been established
(Table III in Division 15 of Part B of the Food and Drug Regulations [34]). A common
policy, between Health Canada and the Canadian Food Inspection Agency (CFIA),
regarding the use of administrative MRLs (AMRLs), was established in 2002 as a
mechanism for applying limits to authorized drugs prior to their promulgation in the
Regulations. In 2004, the VDD of Health Canada made a commitment to establish
MRLs with every notice of compliance (NOC) for food-producing animal drugs.
MRLs and AMRLs enhance health protection by identifying and measuring the risks
of VD residues to the health of consumers and as a result, appropriate action can be
taken to protect Canadians from those risks.
In addition, the Asian-Paci
c area also shows concern about food safety by
establishing MRLs for different substances in food. For instance, in Japan, the
Ministry of Health, Labour and Welfare (MHLW), through the Food Safety Basic
Law, establishes an extensive
“
positive list
”
with the MRLs for pesticides, veterinary
