CEUREG XXII Forum, Session IV Latest Changes to the Plant Protection Products V.N. Rakitskii, CEUREG Forum XXII, 2018 Regulation in Russian Federation V.N. Rakitskii, T.A. Sinitskaya, G.V. Masaltsev FBES “FSCH named after F.F. Erisman ” of the Rospotrebnadzor 29-30 October 2018 1 Vienna, Austria
Summary of Legislative and Regulatory Acts • Federal Law « On safe handling of pesticides and agrochemicals » ( on 19.07.1997 № 109 -FL with revisions). • Federal Law « On sanitary-epidemiologic population wellbeing » ( on 30.03.1999 № 52 -FL, with revisions). • Federal Law « On quality and safety of food » ( on 02.01.2000 №29 -FL). V.N. Rakitskii, CEUREG Forum XXII, 2018 • Federal Law « On technical regulation » ( on 27.12.2002 № 184-FL). • Federal Law « On consumer rights protection » ( in edit. Federal Laws on 09.01.1996 № 2 -FL, on 17.12.1999 № 212 -FL). • Uniform sanitary-epidemiologic and Hygienic requirements for goods, which are subject to sanitary-epidemiologic surveillance (control), approved by the Decision of the Customs Union Commission on 28.05.2010, № 299 . • Decision of the Customs Union Commission № 721 « On the application of international standards, recommendations and guidelines » on 22.06.2011. • Russian Federation Government Act « On provision of harmonization of the Russian sanitary-epidemiologic requirement, veterinary-sanitary and phytosanitary measurements with international standards » on 28.09.2009 № 761. 2
Summary of Legislative and Regulatory Acts (Cont.) • Order of the Federal Agency on Consumer Rights Protection and Human on 01.08.2006 № 225 « On sanitary-epidemiologic expert evaluation of pesticides and agrochemicals » . • « Hygienic requirements for the safety of the processes of evaluation, storage, transportation, offtake, application, deactivation and disposal of pesticides and agrochemicals ». Sanitary rules and norms. SanR&N 2.2.2584-10. Enacted by the Head Government Sanitary Physician of the Russian Federation’ Act from 25.05.2010. V.N. Rakitskii, CEUREG Forum XXII, 2018 • « Hygienic requirements for the safety and nutritional value of food. » Sanitary rules and norms. SanR&N 2.3.2.1078-01. Enacted by the Head Government Sanitary Physician of the Russian Federation’ Act on 14.11.2001 № 36 from 01.09.2002. • Hygienic Norms for pesticides content levels in objects of the environment. HN 1.2.3539-18. Enacted by the Head Government Sanitary Physician of the Russian Federation’ Act on 10.05.2018 № 33. These documents are accepted by the experts of the Customs Union countries and are enacted as intergovernmental normative acts by the Decision of the Customs Union Commission. 3
Summary of Legislative and Regulatory Acts (Cont.) • « The scientific justification for maximum residue levels of pesticides in food. » Methodology Guidelines MG 1.2.2960-11, 29.07.2011. • « Risk assessment of the effects of pesticide residues in food on population ». Methodology Guidelines MG 1.2.3216-14, 22.08.2014. V.N. Rakitskii, CEUREG Forum XXII, 2018 • Hygienic recommendations for study of quality of pesticide-treated food . № 01 - 19/139-17 on 29.12.1995. • Hygienic classification of pesticides according to the degrees of hazard (Annex № 1 to SanR&N 1.2.2584-10, enacted on 02.03.2010). • Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. • Codex Alimentarius Commission. Procedural Manual (Joint FAO/WHO Food Standards Programme). 4
System of State Authorization of Pesticides in the Russian Federation State Authorization of Pesticides Federal Service on Veterinary and Phytosanitary Supervision (Rosselkhoznadzor) Biological Expert Evaluation Ecological Expert Evaluation Toxicological-Hygienic Expert Evaluation (regulations for pesticides use) V.N. Rakitskii, CEUREG Forum XXII, 2018 Federal Service on Supervision Ministry of Ecology in the Field of Consumer Agriculture Ministry Rights Protection and Human and Natural Resources Well-being (Rospotrebnadzor) Leading research centers Leading research centers Leading research centers - All Russia Research Institute of - All Russia Institute of Plant - Institute of Pesticides Hygiene, Toxicology Nature Protection Protection and Chemical Safety, FBES “FSCH named after - Agricultural Academy named F.F. Erisman ” (chemical pesticides) - Moscow State University after Timiryazev - Institute of Disinfectology (pesticides in - All Russia Institute of Chemical everyday life and human health protection) Plant Protection Substances - Research Center for Toxicological and 5 Hygienic Regulation of Biopreparations (biopesticides)
HYGIENIC CLASSIFICATION OF PESTICIDES (SanR&N 1.2.2584-10, 3d version 1996, 2001 and 2010) a) General toxicity and stability in soil ( Publication is in Regulatory Toxicology and Pharmacology 28, 79-84, 1998 ) CLASS OF HAZARD INDEX 1 2 3 4 Extremely Highly Moderately Slightly hazardous hazardous hazardous hazardous Mean lethal < 50 51-200 201-1000 > 1000 dose after V.N. Rakitskii, CEUREG Forum XXII, 2018 intragastric administration, mg/kg Mean lethal < 100 101-500 501-2000 > 2000 dose after skin application, mg/kg Mean lethal < 500 501-2000 2001-20000 > 20000 concentration in the air, mg/m 3 Stability (soil) Time of Time of Time of Time of degradation to degradation to degradation to degradation to non-toxic components non-toxic non-toxic non-toxic during 2 month components – components components- > 1 year 6-12 month 2-6 month 6
1 2 3 4 Effect 3A 3B Skin lesions followed Pronounced Evident erythema Weak (hardly No irritating action. Skin by scab formation, erythema and edema and/or edema. These discernible) irritation severe edema (1 mm rising). These signs of irritation are erythema and/or spreading beyond a symptoms are maintained during edema. targeted section by maintained during not less than 2 days. These symptoms of more than 1 mm, and not less than 3 days. irritation disappear abrupt hyperemia. for 1 day. These symptoms of irritation are maintained for more than 3 days. Weak hyperemia of Lesions (irreversible) Pronounced Evident hyperemia of No irritating action. Irritating conjunctive and/or of eye tissues or very hyperemia of conjunctive and cornea (vessels are V.N. Rakitskii, CEUREG Forum XXII, 2018 effect on eyes pronounced conjunctive and cornea (some vessels injected), not hyperemia of cornea (deep are poorly pronounced edema, mucous much eye moistening. conjunctive, diffusive reddening), discernible), edema These signs of pronounced edema – evident edema: lids with partial lids membranes irritation disappear lids are nearly are half closed; turning inside out, during a day. completely closed, cornea is opaque, iris iris details are poorly cornea is opaque, iris is not visible, reaction discernible, eyes is not visible, no towards light is excretions moisten response to light, maintained; intense lids. These symptoms very intense excretions moisten are maintained for excretions moisten lids and skin around not less than 2 days. lids and skin around eyes. These signs of eyes. These signs of irritation are irritation are maintained during maintained for more not less than 3 days. than 3 days. Notes: Experimental animals are rabbits (3-6 animals in group). 7 Reaction is considered significant if it is evident for not less than 34% of animals. Periods of observation of experimental animals: 14 – 21 days after the exposure.
b) Allergic reactions 1 2 3 4 Sufficient evidence Limited evidence of allergic reactions in Sufficient evidence of sensitizing effect Lack of sensitizing of allergic humans in epidemiological studies in experimental animals effect in the reactions in and/or in clinico-allergological studies standard set of humans in (when the possibilities of specific tests epidemiological allergo-tests are limited) together with studies and/or in sensitizing effects in experimental clinico-allergologic animals studies confirmed Subclass 2A Subclass 2B Subclass 3A Subclass 3B by specific Sufficient evidence Sufficient evidence Moderate Weak allergen: allergo-tests of an extremely of a strong allergen: sensitizing effect together with/or strong sensitizing sensitizing effect sensitizing effect in less than 30% without evidence effect in in experimental in more than 30% animals without V.N. Rakitskii, CEUREG Forum XXII, 2018 of sensitizing experimental animals: positive experimental statistical effects in animals: positive effect is produced animals with significance in experimental effect is produced by all methods of statistical specific allergo- animals by all methods of sensitization in significance (P < tests in vivo and in sensitization in 50% animals with 0.05) of differences vitro 100% animals statistical in the most with high significance (P < sensitive specific statistical 0.01-0.05) of allergo-tests in significance (P < differences vivo and in vitro 0.001-0.01) of between the differences indices of specific allergo-tests in between the vivo and in vitro indices of specific allegro-tests in vivo and in vitro 8
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