EPA officially recognizes Israeli environmental pre-clinical studies

The new agreement with the EPA will help Israel compete globally in the environmental field.In a move that will enable Israeli environmental products to find their way more quickly to the American and European marketplace, the U.S. Environmental Protections Agency …

The new agreement with the EPA will help Israel compete globally in the environmental field.In a move that will enable Israeli environmental products to find their way more quickly to the American and European marketplace, the U.S. Environmental Protections Agency (EPA) has agreed to recognize Israeli research facilities which conduct pre-clinical tests for the registration of toxic materials, pesticides, and
other materials affecting the environment.


The agreement, which was signed by the EPA and the The Israel Laboratory Accreditation Authority (ISRAC), associated with the Ministry of Industry & Trade, is being touted as a major advancement for Israeli companies dealing with environmental issues.

The agreement is another demonstration of the close cooperation between Israel and the US and paves the way towards a Mutual Recognition
Arrangement (MRA) with the EPA on Good Laboratory Practices (GLP), due to be signed when EPA inspectors are slated to arrive in Israel in June.


Before this agreement, results from Israeli laboratories could not be used in submitting registration dossiers for toxic materials and pesticides in the U.S. The new agreement will therefore help Israel compete globally in
this field. In addition, the accord will save costs and time for trials in Israel and
the U.S., before new products are introduced in the U.S. market, and facilitate marketing there.

Bachtochem Ltd. located in Ness-Ziona, which has accreditation in everything from fruits and vegetables and medical devices, to medicinal herbs and cosmetics, is just one laboratory that will reap the benefits of this agreement. Shoshi Assa, the company’s managing director, says the agreement is “a very big step forward” for the company and it could give Bactochem international recognition as well as generating more work for the laboratory. In addition, she says this could lead to the creation of more jobs within the laboratory.

“It may also help keep more of our scientists here in Israel if there is more work. They won’t have to go abroad to find jobs,” she says.

Assa’s sentiments are upheld by Etty Feller, head of the Biology, Chemistry, and GLP Department at ISRAC in Ramat Gan. Feller says the benefits of an MRA with the EPA for both the US and Israel are far-reaching. While admitting that she is a scientist and not a marketing expert, Feller believes such an agreement can only benefit the Israeli economy.

“Studies that used to be performed abroad can now be performed here in Israel, instead of those studies being conducted in the EU or the US,” says Feller. “I think it could also create more work here and professionals in the field
will be able to stay in Israel rather than having to go overseas.”

The seeds for ISRAC were sown almost a decade ago when the Israeli government decided in 1994 to set up a National Authority for the
accreditation of testing and calibration laboratories, and empowered the Minister of Industry and Trade to execute this resolution as a voluntary scheme for laboratories wishing to be internationally recognized for their
competence in testing. ISRAC was established following the passage of the Knesset law in 1997.

The Authority wasted little time, and in March 1999, Secretary William M. Daley and then Israeli Minister of Industry and Trade, Natan Sharansky, co-chaired the sixth biannual meeting of the US.-Israel Science and Technology Commission(USISTC).

As a direct result of that meeting, the Commission agreed to allocate $5 million for joint biotechnology and environmental projects to be solicited through a call for proposals by the US-Israel Science and Technology
Foundation. Private sector companies participating in the new projects
contributed an additional $5 million.

Specifically, the Commission agreed to support the GLP harmonization project involving joint US-Israel training and workshops, as well as the “Heart Knows No Borders’ paperless elimination project.

Feller was among those from ISRAC who participated in the GLP courses held in Israel and the US. The courses were conducted by personnel from the US EPA, the FDA (Food and Drug Administration), and personnel from the EU.
Today ISRAC has some 42 accredited laboratories in the area of food, water, cosmetics and pesticide chemistry, biology, microbiology testing laboratories as well as many calibration, engineering, construction
laboratories DNT (non destructive testing) and EMC (telecommunications). It is the only Authority in Israel which is internationally and legally recognized to accredit testing and calibration laboratories according to the
International Standards Organization (ISO) and recognizes laboratories in accordance with the OECD (Organization for Economic Cooperation and
Development) directives of GLP.

This latest agreement in the field of GLP is a major step forward for ISRAC, allowing this relatively small and young, but dynamic accreditation authority to work closely with the highly-respected and internationally
recognized US Environment Protection Agency.