Docstoc

Slide 1 - PAN Europe

Document Sample
Slide 1 - PAN Europe Powered By Docstoc
					Endocrine-active pesticides:
   risk to human health.
        Hans Muilerman,
          PAN Europe
     www.pan-europe.info
      Pesticides, one of the
    remaining unsolved global
environmental and health problems
Reduction number of pesticides in
   Europe doesn’t help much

• Commercial considerations
prevailed
• No use of strict criteria for
health and environment
• Big loophole: 80
‘withdrawn’ pesticides get
new chance on basis of old
law
• Pesticide package used in
agriculture largely
unchanged
• Chemicals win; alternatives
(BC) loose
            Intensive mono-functional
         agriculture still dominating style
                  15

                  10
                                                                                                      Use of pesticides,
                  5                                                                                   kg/ha, Eurostat,
                                                                                                      2001.
120               0                                   l
                                       d    ce               ly   y        ia      ain     rk
                        um ands     lan ran         ga    Ita man      str               ma w ed
                                                                                                 en
                     lgi  rl     ng             rtu                 Au          Sp
100                Be the       E        F   Po              G er                   D en     S
                      Ne

80

60
                                                                     Use of
40
                                                                     pesticides
                                                                     in kg/ha,
20
                                                                     CBS, NL,
                                                                     2000.
 0
               po H




                 ca y
                 es y




             at /GH
                        H

         to um h




                 on s




                          e
                 pa y



               ca ts



                         at
              m ions




                 w s
                        H
                      lip
                       lil




                       le
                       rr




                      ag
             st toe
                        t




                    rro
                      G




                     he
            he cin
                    /G




                     G




                    be

                    rs
                   tu




                  bb
                   r/
                  s/




                  ta




                  w
          nt ya




                be
               oe




               ra
     s

               h
  ro



              n




           cu
           m




        cu
       sa
     ry
  ch
     Multiple exposure through food
                increasing
30


                                                                                 % EU-samples
25                                                                               with multiple
                                                                                 residues

20



                                                                                 Highest reported
15
                                                                                 number of
                                                                                 different
10                                                                               pesticides in one
                                                                                 sample

 5
     7

             8

                     9

                             0

                                     1

                                             2

                                                     3

                                                             4

                                                                     5

                                                                             6
99

         99

                 99

                         00

                                 00

                                         00

                                                 00

                                                         00

                                                                 00

                                                                         00
1

         1

                 1

                         2

                                 2

                                         2

                                                 2

                                                         2

                                                                 2

                                                                         2
Even actual MRL’s unsafe
EU assessment reports of pesticides (based
  on industry GLP) deny open literature

 Example Mancozeb (Thyroid eff.):
 NOAEL 4,8 mg/kg (DAR) vs. 0,4 mg/kg, LOAEL in-vivo
 rat, multiple tumors, (F.Belpoggi Ann. N.Y. Acad. Sci.,
 2002)

 Example Amitrole (thyroid eff.):
 NOEL 2,9 mg/kg (DAR) vs. LOEL 0,05 mg/l inhalation
 in-vivo, follicular epith. hyperplasia (BKH collection)

 Example Picloram (anti-androgen):
 NOAEL 20 mg/kg, US-EPA (Dow) 7 mg/kg, IARC
 LOEL 10 mg/kg

 Example Linuron (anti-androgen):
 LOAEL chosen on basis of “decreasing pituitary
 tumors at increasing doses”
 (EU DAR).
 Industry-friendly climate in Brussels
   one reason for lack of progress.
[Example from EFSA opinion 31-1-2007 on data requirements pesticides].:


• SANCO working document 2006 on data requirements “has been
  subject to extensive consultations with Member States and
  industry, whose comments have been taken into account”.
• EFSA opinion arguing that a notifier should always get the
  opportunity to propose an alternative to a particular study, “handling
  of such cases will generally be assisted by dialogue between
  the notifier and regulatory authority at an early stage in the
  approval process”.
• EFSA Opinion suggesting to follow ILSI HESI proposals on risk
  assessment (ILSI HESI is an industry dominated institute with also
  government people present).
     Loads of evidence in academic
      studies on endocrine effects
• Fungicide Carbendazim: decreased fertility, testis weight, sperm
  production;
• Fungicides Maneb and Mancozeb: Thyroid effects;
• Herbicide Linuron: Binding to androgen receptor;
• Insecticide Dimethoate: Deceased Thyroid hormones, T3 and T4;
• Insecticide Malathion: Suppression T3 and T4, reproductive effects;
• Herbicide Amitrole: Thyroid effects, pituitary tumors;
• Fungicides Tebuconazole and Epoxiconazole: anti-androgen,
  reduction testosterone levels, post-implantation loss;
• Fungicide Iprodion: Thyroid hormone disruption, poss. neg. effects
  on fetal brain development
• Fungicide Procymidone: anti-androgen blocking AR; disruption of
  male reproductive development
• And others like Atrazine, Prochloraz, Alachlor, Metam-sodium,
  Endosulfan and Vinclozolin, but also new pesticide Tepraloxydim
    Potential health damage to society
                enormous

•   Prostate cancer (rising)
•   Breast cancer (rising)
•   Attention deficit hyperactivity disorder (rising)
•   Infertility and male and female reproductive disorders, low sperm quality in
    parts of Europe
•   Miscarriage
•   Hyper allergic diseases
•   Asthma
•   Obesity (prevalence in infants growing)
•   Heart disease
•   Type 2 diabetes
•   …………………


Are we able to prevent another asbestos disaster from happening?
(early signals on asbestos 1898, ban only about 100 years later, 250.000 – 400.000 asbestos
    cancers to be expected in W-Europe in the next 35 years due to past exposures)
Old Directive was perfectly well capable
     of dealing with ED-pesticides
Art.4 on approval: “it is established in the light of current scientific
   and technological knowledge and shown from appraisal of the
   dossier provided for in Annex III…….it has no harmful effects on
   human health, directly or indirectly.

Annex III, data requirements (94/79/EC), ao. the ‘musts’
• Oral 90-day study (oral 28-day study option)
• Genotox in vitro (in vivo or in vitro depending outcome)
• Long term toxicity and carcinogenicity (two years rat and carc.
  mouse)
• Reproductive toxicity (2-gen rat)
• Developmental toxicity studies
• Delayed neurotoxicity studies (OECD 418)
 So, why are endocrine effects denied so
     long in the EU approval system?

• DG SANCO concerned getting the list done, pressed to
  deliver, not so much mattering how
• EFSA narrow-focused on DAR of Member States/ Industry
• Academic studies not taken into account
• Decision-taking body (Standing Comm.) voting based on
  agricultural, regional or commercial concerns, not always
  based on health concerns
• Denmark and Sweden lonely heroes in trying to get EDC on
  the agenda (Carbendazim, Linuron).
• Cumulative effects most worrying for a health point of view
  (recent Danish report on kids); unnecessary delay of EFSA to
  come up with methods
    Looks like new Regulation has to realise
        break-through (Annex II, 3.6.5).
•   3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of
    the assessment of Community or internationally agreed test guidelines or other available
    data and information, including a review of the scientific literature, reviewed by the
    Authority, it is not considered to have endocrine disrupting
    properties that may cause adverse effect in humans,                                unless the
    exposure of humans to that active substance, safener or synergist in a plant protection
    product, under realistic proposed conditions of use, is negligible, i.e. the product is used in
    closed systems or in other conditions excluding contact with humans and where residues
    of the active substance, safener or synergist concerned on food and feed do not exceed
    the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No
    396/2005.
• Within four years             from the entry into force of this Regulation, the Commission shall
    present to the Committee referred to in Article 79 (1) a draft of the measures concerning
    specific scientific criteria for the determination of endocrine disrupting properties to be
    adopted in accordance with the regulatory procedure with scrutiny referred to in Article
    79(4).
•   Pending the adoption of these criteria, substances, that are or have to be classified, in
    accordance with the provisions of Directive 67/548/EEC, as carcinogen category 3 and
    toxic for reproduction category 3, shall be considered to have endocrine disrupting
    properties.
•   In addition, substances, such as those that are or have to be classified, in accordance with
    the provisions of Directive 67/548/EEC, as toxic for reproduction category 3 and which
    have toxic effects on the endocrine organs, may be considered to have such endocrine
    disrupting properties.
 Major hurdle for effective action changing
         mindset on traditional RA
• In testing ED-chemicals we need to realize that embryo and fetus are
  developed under the control of hormones at parts per billion or parts
  per trillion. As the baby matures hormone concentrations are
  regulated by sensitive, thermostat-like feedback control systems in the
  brain. Traditional RA would therefore be useless to assess ED-effects
  to its full extend.
• The endocrine system needs to be considered as an interconnected
  whole; all endpoints and systems (pancreas, adrenal gland, bone,
  mammary tissue, adipose tissue, etc.)
• Special ‘windows of vulnerability’ to be tested
• Low dose effects to be taken into account.
• Non-monotonic dose-response curves be seen as a possibility (DES
  and DEPH different effects at low and high dose), threshold concept
  needs revision
• Late occurrence long after exposure has ceased assessed
• Assessment of combination effects should be standard in RA, being
  daily reality for people
BPA discussion illustrates need new
       thinking                         (Myers et al., EHP, 117, 11, 2009)




   25
                           Range of serum
                           concentrations
                         commonly observed
                             in people
   20




   15

                                                                     Proliferation by
                                                                     BPA in LNCaP
   10                                                                cells, % labelled
                                                                     cells


    5




    0                                                                Apparent NOAEL
        0 ppb   0,023 ppb 0,23 ppb   2,3 ppb   23 ppb   230 ppb
  How to deal with industry-bias in
              testing?
• Problems with industry-GLP testing
   –   Review of 206 studies on health of soft drinks: 0% unfavorable outcome for industry-funded
       studies vs. 37% for no industry funding (Lesser, PLOS, 2007);
   –   In tobacco research industry-funded studies very 88x more likely to conclude passive
       smoking is not harmful (Wise, BMJ, 1998);
   –   Hundreds of academic studies reporting harm at low doses of Bisphenol A while all, but few,
       industry-GLP studies conclude BPA safe (Myers, EHP, 2009)
• Academic studies vs. GLP
   –   Reputation and quality of scientists in universities known
   –   Peer-review of studies in international journals
   –   Studies in open literature can be replicated and discussed openly
   –   Conclusion: Academic studies should always be valued more than GLP-studies, and
   –   Repeat GLP-studies which differ from academic studies in independent laboratories
• Involve scientists actively publishing on ED
   –   See TEDX-proposal of Theo Colborn
• Asking for mechanism of action is obstruction
   –   Even mechanism of eggshell thinning by DDT not completely elucidated
   –   Same for imposex and molluscs
   –   Same for smoking and long cancer
  Humanity has bad track record
     in avoiding disasters

                   Easter island




Anasazi

                          Maya
              Let’s act now.

     “ If science has taught us anything,
      it is that the environment is full of
                   uncertainty.
 It makes no sense to test it to destruction.

  While we wait for the doctor’s diagnosis,
           the patient may die”

               Prince Charles.

And start banning the most harmful chemicals

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:3
posted:3/21/2012
language:
pages:18
yaohongm yaohongm http://
About