FoodLegal Lawyers and
Consultants In response to an article in
our April 2009 issue of FoodLegal Bulletin, we received a letter to the Editor
from Mr Steve McCutcheon as Chief Executive Officer Australia’s
food standard-setting agency, Food Standards Australia
New Zealand.
The letter outlines a division in legal responsibilities for detection and
enforcement of the regulations governing agricultural and veterinary chemicals used
in Australia
and contaminants in the food supply. Letter to the Editor from
CEO of FSANZ Dear Mr Lederman I am writing in regard to the article on regulation
of agricultural and veterinary chemicals in Australia in the March [sic] 2009 edition
of Food Legal [see our April 2009 article “Australian
regulation of agricultural and veterinary chemicals: Who is having two-headed
fish for dinner?”]. I thought there would be some value in me providing
you with a summary of the current roles of both the Australian Pesticides and Veterinary Medicines Authority (APVMA) and Food
Standards Australia New Zealand (FSANZ) in promulgation of Maximum Residue
Limits (MRLs) into food legislation. FSANZ and the APVMA have separate but defined roles
in establishing MRLs and take a collaborative approach to the advancement of
MRLs into food legislation. We have a
shared commitment to the safe and legitimate use of agricultural and veterinary
chemicals and ensuring that resulting residues in food are safe for
consumers. Further details on these
roles are outlined in Attachment 1. FSANZ is committed to ensuring that practical and
flexible mechanisms exist to consider MRLs for residues in imported food. FSANZ is currently taking a case by case
approach to each circumstance relating to MRL amendments that may be relevant
for imported foods, and considers this the most appropriate approach in the
short-term. Further details on these arrangements are also outlined in Attachment
1. You may wish to note that various opportunities exist
for industry to advocate MRL amendments such as Codex MRLs or MRLs for food
imported from another country that may differ from an APVMA MRL notification in
one of the regular FSANZ MRL Proposals. In addition, industry can consider making an Application for an MRL
amendment to FSANZ independently of a notification of the APVMA. In all these situations, to facilitate entry
of an MRL in the Australia New Zealand Food Standards Code, it is important
that industry considers precisely what MRLs are needed, provides justification
for the MRL amendment and considers what mechanism meets its needs. In regard to endosulfan, although New Zealand’s Environmental Risk Management
Authority (ERMA) withdrew the approvals for the insecticide endosulfan and
prohibited its importation, manufacture and use in New
Zealand, you should note that the use of endosulfan in New Zealand was
not considered a food safety issue by the New Zealand Food Safety Authority
(NZFSA). Moreover, the NZFSA has
publicly stated that residues of endosulfan have never exceeded established
MRLs or exceeded appropriate reference health levels in testing undertaken as
part of the Food Residue Surveillance Programme and the Total Diet Survey. Following an extensive review on endosulfan, the
APVMA’s current position is that endosulfan registrations in Australia
remain appropriate, given the scientific evidence reviewed and the controls
that are in place. Therefore, the current MRLs for endosulfan are appropriate
to account for legitimate use of this chemical. Past Australian Total Diet
Studies have found that residues of agricultural and veterinary chemicals in
food, including endosulfan, are low and that dietary exposure to these residues
is well within the reference health standards. Therefore, FSANZ considers
that public health and safety is appropriately protected by permitting
legitimate use of endosulfan in accordance with legitimate use levels in Australia. [Editor’s emphasis added] In conclusion, I hope this clarifies the current
regulatory environment for agricultural and veterinary chemicals in Australia,
the roles of the APVMA and FSANZ and the mechanism for inclusion of an MRL in
the Code. Yours sincerely Attachment 1 Role of the APVMA in
establishing maximum residue limits (MRLs) Agricultural chemical products and veterinary
chemical products are used to control pests and diseases of plants and animals
and assist producers in providing wholesome foods from healthy plants and
animals. The Australian Pesticides and
Veterinary Medicines Authority (APVMA) administers the National Registration
Scheme for Agricultural and Veterinary Chemicals in Australia. The Scheme registers and
regulates the manufacture and supply of all agricultural chemical products and
veterinary chemical products used in Australia, up to the point of
wholesale sale. The safety and performance of all chemicals that are
used in food producing crops and animals must be assessed by the APVMA prior to
registration to ensure that the health and safety of consumers is protected. As
part of that assessment process, using data submitted with the registration
application, the APVMA determines the likely level of chemical residues
remaining at the time of harvesting or slaughter. Drawing on this information
and considering relevant health standards the APVMA recommends MRLs. No product
is registered unless these levels are safe for people consuming treated foods. Role of FSANZ in
establishing MRLs in food legislation The APVMA regularly makes
notifications to Food Standards Australia New Zealand (FSANZ) for specific maximum residue limits (MRLs) to be included in the Australia New Zealand Food Standards Code (the Code) so that the MRLs in the Code reflect the approved use of
agricultural and veterinary chemical products in Australia. FSANZ’s primary role in
developing food regulatory measures for agricultural and veterinary chemicals
is to ensure that the potential residues in food are within reference health
standards. FSANZ conducts and
reviews dietary exposure assessments in accordance with internationally
accepted practices and procedures. In assessing the public health and safety
implications of chemical residues, FSANZ considers the dietary exposure to
chemical residues from potentially treated foods in the diet by comparing the
dietary exposure with the relevant reference health standard. FSANZ will not
approve variations to limits in the Code where dietary exposure to the residues of a chemical could risk
public health and safety. The steps undertaken in
conducting a dietary exposure assessment are: The estimated dietary exposure to a chemical is
compared to the relevant reference health standard/s for that chemical in food
(i.e. the acceptable daily intake (ADI) and/or the acute reference
dose (ARfD)). FSANZ considers that dietary exposure to the residues of a
chemical is acceptable where the best estimate of this exposure does not exceed
the relevant standard/s. Standard 1.4.2-Maximum
Residue Limits Standard
1.4.2 includes MRLs in the Schedules to the Standard for permitted chemicals
along with the specific commodities or food products that may contain them.
Currently, under Commonwealth of Australia, State and Territory food
legislation (subject to exceptions for food from New Zealand) there must be no
detectable residue in a food commodity for which an MRL has not been listed in
Standard 1.4.2. It should be noted that MRLs are not direct safety
limits but are monitoring limits set to ensure that approved chemical products
are used in accordance with approved conditions of use. However, as noted above
consideration is always given to the relevant reference health standard when an
MRL is established. MRLs are included in
food legislation to allow the legal sale of safe and legitimately treated food. Relationship between Australia and New Zealand in establishing MRLs All food imported into Australia
must comply with the requirements in Standard 1.4.2, except for food from New Zealand. Australia and New Zealand
independently and separately develop MRLs for agricultural and veterinary
chemicals in food. The Trans Tasman Mutual Recognition Arrangement (TTMRA)
between Australia and New Zealand
commenced on 1 May 1998. The
following provisions apply under the TTMRA: Establishing
MRLs for foods that are not part of the APVMA Notifications FSANZ seeks comment on all amendments to MRLs in the
Code, and identifies relevant Codex MRLs as part of the consultation
documentation. FSANZ also considers submissions for legitimate MRLs that may be
different from an MRL notified by the APVMA. In addition to the regular consideration of APVMA MRLs, applications may
be made direct to FSANZ for any MRL and this would be considered in accordance
with the FSANZ Act 1991. Guidelines and formats for making an application are
available on the website of FSANZ. Key issues for FSANZ will be the
safety of the residues, the legitimacy in food and the justification for
presence in food. Therefore, industry or another regulatory agency may
advocate specific MRL amendments through the following mechanisms: Potential applicants and advocates of MRL amendments
are encouraged to contact FSANZ. --------------------------------------------------------------------------------------- FoodLegal Bulletin Editor’s
Comments
© Lawmedia Pty Ltd, June/July 2009
Steve McCutcheon
Chief Executive Officer
12 May 2009
FoodLegal Consultancy
www.foodlegal.com.au