lannate® insecticide registration attributes lannate® compared to ops products reversibility...

14
Lannate® Insecticide Registration Attributes Lannate® compared to OP’s products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures & Proposal S N C O

Upload: katelyn-martin

Post on 26-Mar-2015

218 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Lannate® Insecticide

Registration

Attributes

Lannate® compared to OP’s products

Reversibility Studies in Rat

Mexican worker exposure

DuPont Safe Use Measures & Proposal

S

N

C

O

Page 2: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Methomyl Registration

Lannate has been commercialized since 1968 (USA)

Widely registered 80 countries approximately 190 crops (vegetables, fruits, fibers, and plantation

crops)

Variety of formulations available to meet local needs

No severe restrictions or bans based on risk assessment

Is not PIC listed

Page 3: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Insecticidal Attributes

Lannate is anti-acetyl cholinesterase, inhibiting nerve function

Broad spectrum of activity; controls >140 insect species

Fast acting, effective by contact & ingestion; also ovicidal activity

Not phytotoxic, systemic, translaminar

Excellent compatibility with commonly used pesticides

Resistance management tool and fits with IPM

Page 4: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Toxicology Attributes

Acute dermal toxicity is extremely low one of the primary attributes of methomyl 95% of worker exposure is potentially dermal

Acute oral and inhalation toxicity is high

exposure can be mitigated (masks)

Toxicity (acetyl cholinesterase inhibition) is quickly reversible without treatment carbamate insecticide property no delayed neurotoxicity in long term

Effective antidote is available (atropine)

Toxicology studies have shown that methomyl does not cause: developmental toxicity, reproductive toxicity, mutations, chronic toxicity, delayed neurotoxicity, carcinogenicity

Page 5: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Environmental Attributes

Rapid decomposition to natural molecules, no potential to bioaccumulate

Rapid degradation soil: 90% loss in 35 days, low mobility water: half life very short, hours to <7 days

Rapid metabolism plants: half life <3-5 days, short residual on crops, safe for

harvesters (PHI’s 1-7 days) and consumers animals: >50% metabolized or excreted in 24 hrs

Aquatic toxicity acutely toxic to invertebrates but exposure mitigated by label

precautions (no aquatic uses) low potential for chronic toxicity due to rapid degradation

Page 6: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Lannate® Vs. commonly used OP’s

Dermal and dietary safety in comparison to some OP insecticides:

Dermal LD50 ADI* (mg/kg) (ug/kg/day)

methomyl 5880 (rabbit) 30

methamidophos 118 (rabbit) 0.6

monocrotophos 354 (rabbit); 120 (rat) 0.6

demeton S methyl 30 (rat) 0.3

oxydemeton methyl 130 (rat) 0.3

mevinphos 16-33 (rabbit); 4-90 (rat) 1.3

*ADI = Acceptable Daily Intake values determined by JMPR

Page 7: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Time after dosing 30 min. 2 hours 3 hours 4 hoursClinical signs females + 0 0 0

males + 0 0 0

% cholinesterase inhib. vs. controls:Red Blood Cell (RBC) females 41* 0 0 0

males 55* 24* 3 2

Brain females 39* 8# 8# 0

males 46* 16* 8# 1

* = stat. signif icant

# = w ithin control group range

Lannate®: Rat Reversibility Study Results

Page 8: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Mexican Worker Exposure Study

Determine potential dermal and respiratory exposure to mixers, loaders, and applicators during use with backpack sprayers low (cauliflower) and medium (tomato) height crops 15 replicates (5 operators spraying on 3 separate occasions)

GIFAP recommended clothing worn outer cotton tunic and trousers with inner cotton underwear

(dosimeter f/dermal exposure) waterproof gloves with cotton undergloves (dosimeter f/hand

exposure) rubber boots, baseball caps & dust masks (dosimeter f/respiratory

exposure)

Page 9: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Mexican Worker Exposure Study :Summary of Findings

Outer clothing provides a high degree of protection from dermal exposure intercepting 83-93% of total methomyl residue

Respiratory exposure is very low (<0.1%)[dust mask]

Margins of safety for workers applying methomyl to a medium height crop (tomato) with appropriate PPE are: 206 for dermal exposure 3316 for respiratory exposure

Page 10: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Mexican Worker Exposure Study: Results

Measured Methomyl Residue on Backpack Sprayer Applicators

Cauiflower Tomato

Location Deposit(mg)

Percent ofTotal

Deposit(mg)

Percent ofTotal

Outer Suit 26.3 83.0 143.7 93.4

Inner Suit* 5.3 17 9.7 6.3

Face/NeckWipes

0.008 0.025 0.23 0.15

Inner Gloves 0.048 0.15 0.18 0.11

Respirator 0.03 0.095 0.13 0.08

* represents actual dermal exposure to the body

Page 11: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Tomate

Traje protector93.3%

Exposición dermal6.6%

Exposición respiratoria

<0.1%

Coliflor

Traje protector83%

Exposición respiratoria

<0.1%

Exposición dermal

17%

Methomyl residues

Mexican Worker Exposure Study: Results

Page 12: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

Mexican Worker Exposure Study: Tomato Results

Route Exposure* NOEL MOS****

Dermal 0.437 mg/kg 90 mg/kg** 206 (sum of deposits on inner suit and gloves,

face, and neck)

Respiratory 0.0038 mg/kg 12.6 mg/kg*** 3316(deposit on respirator)

*based on a 70 kg person and adjusted to 6 and 4 hrs exposure for dermal and respiratory routes, respectively ** 21-day dermal study in rabbits (exposure 6 hrs/day) *** rat inhalation LC50 study (exposure 4 hrs; no mortality at 1.8 mg/L); assumes 100% absorption by a 0.25 kg rat with a respiration rate of 73 mL/min **** Margin of Safety = NOEL divided by exposure

Page 13: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

DuPont Safe Use Measures

Use of dye (color)

New formulations with bittering agents (mal sabor) to prevent accidental ingestion

Use of constant flow valve for backpack sprays

Labelling with precautions and pictograms

Availability of atropine whenever needed

Safe use training programs

Packaging in water soluble bags for solids and high density plastic bottles for liquids; no large containers

Page 14: Lannate® Insecticide Registration Attributes Lannate® compared to OPs products Reversibility Studies in Rat Mexican worker exposure DuPont Safe Use Measures

DuPont’s proposal to authorities

Discontinue commercialization of liquid Lannate® New 1 oz presentation on WSB to avoid handlingTraining to medical department, to be able to tell

difference between acetyl cholinesterase symptoms and other (heat)

Continue training efforts on good use and Lannate ® management

On the last 3 years, 430 people were trained in El SalvadorAgricultores, cooperativas, Distribuidores:

dependientes de mostrador, Area de ventas, servicio tecnico, bodegueros.