Wellington, New Zealand
May 11, 2004
An audit of US-based GM testing laboratory Biogenetic Services
Ltd (BGS) by the
Ministry of Agriculture and Forestry (MAF) identified that
BGS was deficient in several audited areas, including the way it
was interpreting and reporting testing results. Subsequent
MAF-sponsored tests of BGS-certified seed consignments have
revealed a very low level of GM in two of 15 consignments tested
to date.
MAF has a zero tolerance for GM material in imported seed for
sowing. MAF-accredited international laboratories undertake GM
testing and MAF routinely audits them to ensure they meet New
Zealand’s strict testing standards.
MAF’s director of plant biosecurity, Richard Ivess, said as a
precaution MAF chose to retest 15 of 52 consignments of seed
material shipped to New Zealand that had been tested by the BGS
laboratory since January 2003. These 15 consignments represent
about 80 percent of the volume of seeds in the 52 consignments
involved.
Richard Ivess said today that test results supplied to MAF by
AgriQuality GMO Services in
Melbourne
showed the presence of GM material at a very low level (less
than one GM seed per 2,000 seeds) in two of the 15 consignments
tested. The remaining 13 consignments returned negative results.
“The GM construct in one consignment has been identified as
LibertyLink T25. Maize containing LibertyLink T25 is widely
grown in the United States and Canada. While this GM construct
has been approved by Food Standards Australia New Zealand as
safe for human consumption, MAF has been advised that that the
type of maize in question is grown in New Zealand for stock feed
and is not used for human foodstuffs,” Richard Ivess said.
“One consignment remains totally in storage, as does the
majority of the other consignment, all of which will be seized
by MAF. MAF is working with the importer to determine where the
remaining seed is and whether it has been planted or harvested.
MAF will respond appropriately as soon as it has all this
information.
“MAF is now endeavouring to re-test the remaining 37 seed
consignments previously certified by BGS and shipped to New
Zealand, which represent only 20 percent of the total. MAF will
take appropriate action if any of these consignments are found
to contain GM seeds.
“Since we were advised of the preliminary results on Wednesday 5
May 2004, we have been in consultation with ERMA New Zealand, the
Ministry for the Environment, other Government agencies and
industry organisations to determine the best practicable steps
for managing this issue. These discussions continue.
“We have also discussed this matter with the seed importing
company involved and have its full co-operation with our
enquiries. MAF is continuing its standard response process,
aiming to identify locations and response options,” Richard
Ivess said.
GM maize – Questions and Answers
1) Why did MAF accredit the United States laboratory
Biogenetic Services Ltd (BGS) to test seeds being exported to
New Zealand?
New Zealand law has zero tolerance for genetically modified
organisms that have not been approved to grow here under the
provisions of the Hazardous Substances and New Organisms Act
1996. MAF requires all seed for which a commercial genetically
modified line is available that is to be imported into New
Zealand to be tested before it gets here to ensure there is no
unapproved GM seed present. As there have been no approvals to
grow GM seed in New Zealand, if GM seed is found the seeds are
not allowed into the country.
New Zealand imports a lot of corn and maize seed from the US. It
makes sense for exporters to test their seeds before they ship
them, so MAF accredited BGS as one laboratory able to do testing
for seed for sowing consignments destined for New Zealand.
2) What is the process for auditing laboratories? Why
did BGS fail its MAF audit?
MAF audits all its accredited
laboratories to ensure they meet
New Zealand’s standards for imported seeds for sowing. Details
of the audit process are available on the MAF web site.
http://www.maf.govt.nz/biosecurity/imports/plants/genetically-modified-organisms.htm
As part of this process, MAF performed a
site audit of Biogenetic Services Ltd in March 2004. This audit
identified several significant deficiencies and MAF immediately
suspended BGS’s accreditation.
A copy of MAF’s audit report into
Biogenetic Services is available on the MAF web site.
3) Why exactly did MAF suspend BGS’s accreditation?
As part of a site audit of Biogenetic
Services Ltd MAF discovered several deficiencies:
-
Non-certified controls were used
-
Results were inadequately interpreted
-
Results were inadequately reported
-
Documentation was not well managed.
4) Has the laboratory been re-accredited? When is
this likely to happen?
No. The laboratory is now pursuing an aggressive timetable for
certification to the international standard NZS/ISO/IEC 17025.
MAF will formally re-audit the laboratory to ensure it meets
these standards as part of considering reinstating BGS’s
accreditation.
5) Why did MAF accredit BGS in the first place if it
didn’t meet these standards?
BGS met the required MAF standard (refer
to question 2 web site reference) when first accredited in 2002.
6) What other action did MAF take in response to its
suspension of BGS’s accreditation?
As a precautionary approach, MAF decided
to re-test any seeds certified by BGS as being GM free that were
either en route to New Zealand from the United States, or
already here.
7) How did MAF carry out this testing and what were
the results?
MAF tested 15 out of 52 seed
consignments that had been certified as GM free by BGS and
imported into
New Zealand. 13 tested negative for the presence of GM seeds.
Two consignments reported the presence of very low levels of GM
seed.
8) How did MAF choose the 15 samples that were
re-tested, out of the total of 52? Why were only 15 samples
taken, and will the rest be tested?
These 15 samples represented 80 percent
of the volume certified by BGS that had been imported into
New Zealand. While the seed already tested represents the vast
bulk of seeds that may be planted out in New Zealand, MAF is now
moving to test the remaining 20 percent to ensure they are GM
free.
9) What were the GMOs that were discovered, and at
what level?
In the larger consignment, the precise variety identified is
LibertyLink T25, which is a variety of GM maize approved for
human consumption in New Zealand. Testing indicates presence is
at less than 0.05 percent. This translates to less than 1 seed
in 2,000 or about 50 plants out of every 100,000.
In the smaller consignment, the exact variety of GM maize cannot
be identified because it was detected at such low levels. MAF
has been advised that this consignment has not been planted.
10) Does this represent a risk to human health or the
environment?
No. The variety of GM maize detected in the large seed lot is
widely grown in the United States and Canada. It is approved for
human consumption in many countries, including New Zealand,
although no one has ever applied to the Environmental Risk
Management Authority to grow it here. Furthermore, it is present
in low levels – about 50 plants out of every 100,000.
In the case of the smaller consignment, it was not planted in
New Zealand and therefore poses no threat.
11) Has any of the maize seed been planted, and if so,
where?
MAF has been advised that 1,317 bags of
seed were imported, of which 351 bags were sold to grain and
seed merchants. 966 remain in the importer’s warehouse and will
be seized by MAF.
MAF is currently gathering information
on the status and whereabouts of the 351 bags that were sold and
whether any of the seed has been planted. If MAF finds that some
seed has been planted, it will take the appropriate enforcement
action.
12) Has any of the maize already been harvested?
MAF is currently gathering that
information. It is possible that some crops may have already
been harvested.
13) If the maize has been harvested, could any of it be
in the human food chain?
MAF is currently gathering that
information, although it appears unlikely at this stage. Maize
is generally used for animal feed, either as green feed, silage
or grain. While maize is sometimes used for some food products
such as corn chips and corn flour, MAF understands from growers
that this particular variety is not used for those purposes.
14) What is MAF going to do now?
MAF is working quickly to gather all the
information it requires to determine the most appropriate
response to these findings.
15) How do we test imports of seed?
The New Zealand GM testing regime is one of the strictest in the
world.
MAF tests imported seed for sowing at the border and if there is
any indication of GM content it is not allowed in. MAF tests
every batch of corn seed for sowing (as well as maize seed) as
it comes into the country. A consignment that has been tested
offshore in a MAF-accredited laboratory, according to the method
in our import protocol, will not be tested again unless there
are genuine grounds that GM seeds are present. This means that
seed from non-GM as well as GM producing countries are certified
GM free before it is allowed into the country.
In 2002 the sample sizes for testing for
inadvertent GM content were increased from 1,400 to 3,200 seeds.
This means that the current testing process gives MAF a high
level of confidence (95 percent) that any consignment with a
level of GM presence one seed in a thousand will be detected.
16) Is a low level of GM presence inevitable?
This is difficult to predict.
With more and more GM crops being grown and traded around the
world, there will be more opportunities for GM seeds to be
present in seed supplies. On the other hand, the systems to
separate GM and non-GM crops are likely to improve, driven both
by commercial pressures and demands from governments for
assurances. It is very likely that there will continue to be
incidents like this one, where GM seeds are present
unintentionally. But with appropriate actions and ongoing
assurance systems, it should be possible to keep them isolated.
There is always a chance that low
concentrations of GM seeds may not be detected, but most of the
time they will be detected by the assurance systems that are in
place.
17) What criteria does MAF use to select laboratories
for accreditation for GM testing?
Selection of laboratories is an industry-led exercise, as MAF
cost-recovers this process from the seed importers. After
suggestion by industry of laboratories which they would be
interesting in being accredited, MAF conducts a remote “paper”
audit and assessment against the MAF interim standard
PIT.GMO.AFGMOT.
The following is assessed: detection methods used for GMOs; the
standard laboratory operating procedures used by the facility
and any national or international quality systems adhered to;
the structural aspects of the facility; the equipment available
to carry out testing and the calibration of that equipment; the
role of each staff position and staff competency; the experience
of the facility in the area of GMO testing plant material; and
the independence of the facility.
If the laboratory demonstrates a high
level of competency in this initial part of the process,
provisional accreditation may be awarded. Laboratories are fully
accredited once a site visit and assessment confirms that
facility’s operational competencies as previously assessed
remotely in step 1. Only fully accredited labs can conduct
routine regulatory GMO testing for MAF.
18) Why can’t the testing be done in New Zealand?
In principle, testing could be done in New Zealand, but no
laboratories have been accredited yet for the purpose of
enforcing the Hazardous Substances and New Organisms Act 1996.
MAF has accredited three laboratories for testing – in
Australia, France, and the USA – in order to enforce the
Biosecurity Act 1993, which is focused on imported rather than
domestic products. Importers have to pay the costs of
accreditation and the most useful laboratories are offshore
because most importers would prefer to test their seeds before
shipping.
No importers have asked MAF to accredit
any
New Zealand
laboratories for testing imported seed.
19) Why doesn’t New Zealand grow its own seeds?
New Zealand farmers use both locally produced and imported
seeds. For pasture seeds such as ryegrasses and clovers, we are
world-leaders – breeding and producing our own seeds and
exporting about $60-70 million worth of them around the globe.
For maize and many vegetable crops, the best seeds come from
large and expensive breeding programmes in the major
agricultural producing countries like the USA, Canada,
Australia, and Europe. Because of our size and climate, New
Zealand cannot produce seeds that match the quality and value of
those imported seeds.
There are other reasons as well: some crops lose their vigour
after several generations so new varieties must be imported from
time to time, and many of the best seeds are hybrids that do not
breed true – the next generation is unlikely to have the
qualities that make the variety desirable.
New Zealand farmers realise that to be internationally
competitive, it is essential that they can participate in the
seed breeding and multiplication industry, which must import
seeds.
For further information about The
New Zealand Food Safety Authority visit
www.nzfsa.govt.nz/consumers/food-safety/gm/index.htm
For further information about MAF protocols visit
http://www.maf.govt.nz/biosecurity/imports/plants/papers/gm-seeds/zea-mays-protocol.htm
xxx |