As of 2014, the NZ EPA use toxicological endpoints for assessing toxicity of new pesticides and approving them. These are based on a selection of toxicity studies which give a considered 'safe' NOEL/NOAEL (no observable effect level). These studies are critical in revealing what toxic levels effect the study subject. How dangerous the pesticide is. These studies help define how much we can be exposed to ie., what the application rate is and how much can be sprayed on our food per acre - our permitted residues.
In making a request with the NZ EPA to understand what studies they are currently using to assess glyphosate, I was given the application for GF-1280, (with extracts below), as an example. Recently approved new pesticide active ingredient studies become the decision document for the pesticide product. Therefore GF-1280 can now be used as the 'decision document' proving reference points for toxicological safety of glyphosate in New Zealand in 2014. The studies used for risk assessment, to establish toxicological safety are in the Appendices 1 and 2.
EPA noted 'This substance is used in similar ways to other glyphosate-containing herbicides and so the risks associated with these other substances are considered to be similar to the risks associated with the use of GF-1280. Decisions made on more recent glyphosate-containing substances have therefore been primarily based on the findings of the risk assessment performed for GF-1280.'
The studies used are selected and provided by the applicant, Dow Agroscience.
There are problems:
1. The toxicity studies for glyphosate (Roundup) (Appendix 1) are all private, obtained directly from contracted laboratories that only work with industry – Product Safety Laboratories, Dow, ABC and Covance. They are unpublished and unavailable for review by public sector health representatives or individuals.
2. The Risk Assessment studies for acceptable exposure levels (Appendix 2) for workers (AOEL) are ancient private studies (Suresh 1993 and Hogan 1981).
3. There are no studies considering the full formulation, no studies looking at the endocrine, neurological or digestive systems.
4. The studies proving safety were all provided by the applicant. This is a conflict of interest.
It doesn't matter what the mixture - this decision document becomes all the necessary glyphosate studies required for toxicity assessment - whether it goes on our soil our wheat or our potatoes. The studies used within the discussion document to provide safety when assessing risk are located in Appendices 1 and 2.
New Zealand EPA is using studies conveniently supplied directly by the pesticide organisations to prove safety for Kiwis. Refer here to find published and peer reviewed studies currently not considered by the NZ EPA.
Extract from application no ERMA200031 – Application to Import or Manufacture GF-1280 for Release.
(A maximum application rate of 7.56 kg glyphosate acid/ha per application applies.)
The NZ MPI also refers to the WHO toxicological evaluations to provide a basis for risk assessment in regards to evaluation the safety of glyphosate today.
WHO JMPR Toxicological Assessment Inadequate
The New Zealand MPI states: 'Glyphosate’s toxicity and dietary risk has been reviewed in detail by the Joint World Health Organization/Food and Agriculture Organization Meeting on Pesticide Residues (JMPR), who concluded it is of very low toxicity. MPI has adopted this conclusion in our assessment of the dietary risk of glyphosate to New Zealand and international consumers.'
Let's look at the science covered in the JMPR toxicological evaluations:
The 2011 JMPR glyphosate toxicological evaluation was a smaller Addendum - with a small selection studies submitted to WHO by E.I. du Pont de Nemours and Company, Wilmington, DE, USA. This is not wide ranging science.
The previous WHO JMPR Toxicological evaluation was in 2004, and studies submitted for risk assessment was predominantly supplied by glyphosate producers and marketers, published data was excluded. The new WHO glyphosate ADI that came out of that was from a ancient unpublished corporate study Atkinson et al 1993b - a 2-year study in rats (salivary gland effects) that went on to be the NOAEL that established the ADI of 1.0mg/kg bw (pp127-129). The private, unpublished ten year old study was submitted to WHO by Cheminova A/S, Lemvig, Denmark. It was already old when it was submitted.
The NZ government's rationale is based on narrow unpublished science and ignores all recently released published and peer reviewed research. Possibly the NZ EPA's risk assessment arm has little funding and the scientists are simply unable to undertake a thorough evaluation. Fair enough. However as a result, the NZ government does not consider glyphosate toxic despite a significant amount of science indicating we should not be exposed to it and consequently, it should not be sprayed on our food and animal feed crops.
Update: In March 2015 the IARC condemned glyphosate as genotoxic and a probable carcinogen, scientists have found that the levels of glyphosate in our food that our regulators (Eg. EFSA, US EPA etc) say are safe - have been found by independent scientists to be unsafe - to cause harm. A WHO task force evaluated the IARC findings and in September 2015 advised that 'IARC and JMPR had used “significantly different” databases and that “many studies, mainly from the published peer reviewed scientific literature", that had not been evaluated by JMPR were available to IARC.'
It's time the New Zealand government assessed glyphosate for it's true toxicity - using 21st century, published peer reviewed literature.
Appendix 1: Hazard classification of GF-1280
Table A1.5: Formulation data for GF-1280 Pp 18 - 22
Acute Oral Toxicity. Durando, J. 2005. GF-1280. Acute oral toxicity up and down procedure in rats. Product Safety Laboratories. Dayton, New Jersey, USA. Study ID 050311, 17344.
Acute Dermal Toxicity. Durando, J. 2005. GF-1280 Acute dermal toxicity study in rats- Limit Test. Product Safety Laboratories. Dayton, New Jersey, USA. Study ID 050312, 17345.
Acute inhalation toxicity. Hotchkiss, J. A. et al. 2005. GF-1280 Acute liquid aerosol inhalation toxicity study in F344/DUCRL rats. Toxicology % environmental Research and Consulting. The Dow Chemical Company, Midland, Michigan, USA. Study ID 051151.
Eye irritation. Moore, G E. 2003. GF- 1280 Primary eye irritation study in rabbits. Product Safety Laboratories. Dayton, New Jersey, USA. Study ID 030135, 14416.
Skin Irritation. Durano, J. 2005. GF-1280 Primary skin irritation study in rabbits. Product Safety Laboratories. Dayton, New Jersey, USA. Study ID 050313, 17346
Respiratory Sensitization. Woolhiser M. R. et al, 2006. GF-1280 Local lymph node assay in BALB/cAnNCrl Mice. Toxicology and Environmental Consulting, The Dow Chemical Company, Midland Michigan 48674, USA. Study ID 051095.
Mutagenicity. Mecchi M.S. 2006. Salmonella-Escherichia coli/Mammalianmicrosome reverse mutation assay pre-incubation method with a confirmation assay with GF1280. Covance Laboratories Inc. Vienna, Virginia, USA. Study No 6736-160.
In vivo studies. Charles G. D. et al. 2006. Evaluation of GF-1280 (glyphosate formulation) in the mouse bone marrow micronucleus test. Toxicology & Environmental Research and Consulting. Dow Chemical Company. Midland, Michigan. USA. Study No 061045 (DOW).
Table A1.6: Summary of ecotoxicity data for GF-1280 Pp22-24.
Fish. Hughes C (2006) GF-1280: Acute toxicity to the rainbow trout Oncorhynchus mykiss, determined under static test conditions, ABC study number 50273
Aquatic invertebrates. Hughes C (2006) GF- 1280: Acute toxicity to the water flea Daphnia magna, determined under static test conditions, ABC study number 50276
Algae/Aquatic plants. Hughes C (2006) GF- 1280: growth inhibition test with the unicellular. Green Alga Pseudokirchneriella subcapitata, ABC study number 50274
Earthworm Eisenia fetida. Mallett MJ (2006) GF-1280 Acute toxicity to the earthworm Eisenia fetida, study number CEMS- 2970.
Soil microflora Carbon transformation NitrogenTransformation. Rix S (2007) GF-1280: Effects on soil microflora respiration and nitrogen transformation, study number CEMS-3310
Rat. Durando, J. (2005) GF- 1280 Acute oral toxicity up and down procedure in rats. Product Safety Laboratories. Dayton, New Jersey, USA. Study ID 050311, 17344.
Japanese quail. Gallagher SP, Beavers JB (2006) GF-1280: an acute oral toxicity study with the Japanese quail; project number 379-170
Acute Oral. Hughes C (2006) GF- 1280 Acute oral toxicity test with honey bees (Apis mellifera); ABC study number 50275.
Acute Contact. Hughes C (2006) GF-1280 Acute contact toxicity test with honey bees (Apis mellifera); ABC study number 50272
Table A1.7: Summary of ecotoxicity classifications for GF-1280 based on formulation data provided. P.24
9.1 Aquatic ecotoxicity: Overall: 9.1B, Fish: 9.1C, Crustacean: 9.1C, Algae: 9.1B 9.2 Soil ecotoxicity: Not triggered based on earthworm data. No data on non target plants are available.
9.3 Terrestrial vertebrate ecotoxicity. Not triggered 9.4 Terrestrial invertebrate. Not triggered.
Appendix 2: Risk Assessment
Calculation of Acceptable Operator Exposure Level (AOEL). Pp 26-27
The toxicological endpoint for assessment of occupational (worker) and bystander risks is the AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum daily dose considered to be without adverse health effect for operators, workers and bystanders. It is based on the most appropriate NOAEL from relevant studies and is calculated by dividing the NOAEL by one or more uncertainty (safety) factors selected on the basis of the extent and quality of the available data, the species for which data are available and the nature of the effects observed.
3 studies were used to identify AOEL risks. Most likely these studies are:
(1) A developmental study in rabbits was used by the EC review which determined 30% oral absorption and an UF of 100, to derive an AOEL of 0.2 mg/kg bw/day. [The NOAEL value was not given.] (EC,2002) Page 13.
AOEL Systemic: 0.2mg/kg bw/day based on:
Suresh, T.P. 1993 : Teratogenicity study in rabbits. Unpublished. GLP – yes. Rallis, India. Study no. TOXI:884-TER-RB.
For comments on the Suresh study: Roundup and birth defects: Is the public being kept in the dark? It's high mortality level was questioned.
(2) 90 day rat, NOAEL 150 mg/kg bw/day. Perhaps Dreher, D.M. 1994. Cheminova.
(3) 2 year rat, lowest NOAEL, 31 mg/kg bw/day - 34 years old and by Monsanto.
Lankas, G.R.; Hogan, G.K. (1981): A Lifetime Feeding Study of Glyphosate (Roundup Technical) in Rats: Project No. 772062. Unpublished study received Jan 20, 1982 under 524-308; prepared by Bio/dynamics, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:246617-A; 246618; 246619; 246620; 246621. MRID 00093879.
The EC systemic (the Suresh 1993 study) AOEL of 0.2 mg/kg bw/day was adopted (assuming 30% absorption and an uncertainty factor of 100). Noting that the subchronic and chronic studies reported by the Agency did not lead to classification of glyphosate and taking into consideration the likely duration and frequency of worker exposure, the Agency considers that it is appropriate to use the systemic AOEL value report by the EC (2002) when assessing the risks posed by glyphosate in GF-1280.
Farmers are not safe to use glyphosate / Roundup with the AOEL based on this outdated science.
Note: There is also information on the NZ EPA Chemical Classification and Information Database (CCID). The CCID includes a summary of the data that has led to a particular classification being assigned to the substance. It is not currently updated.
Note: PAN database details GF-1280 is used as a soil treatment and for post-harvest application.
Note: FSANZ actually set our ADI - acceptable daily intake while NZ EPA receive pesticides applications and approve them for use.