Registration of pesticides

When EPA became aware almost five years ago that N-nitroso contaminants occurred in a number of pesticide products, the Agency immediately acted on the authority of Section 3 of FIFRA to place a moratorium on new registrations of pesticides suspected to contain N-nitroso contaminants at detectable levels (this term is defined and explained later in the text). As has been discussed in other papers of the Symposium, many N-nitroso compounds are animal carcinogens and, consequently, suspected human carcinogens. 

During the next two years (1976 and 19TT)> registrants of pesticides and EPA laboratories analyzed several hundred samples of N- containing pesticides for N-nitroso contaminant occurrence and concentration. Results of these analyses have been reported elsewhere. What these analyses revealed was what was... 

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... 

FIFRA requires the registration of pesticides and disinfectants used in medical waste treatment technologies... 

The FIFRA provides procedures for the registration of pesticide products to control their introduction into the marketplace. As such, its regulatory focus is different from most of the statutes discussed in this chapter. While the other statutes attempt to minimize and manage waste by-products at the end of the industrial process, FIFRA controls whether (and how) certain products are manufactured or sold in the first place. 

Intent to Cancel or Restrict Registration of Pesticide Products Containing Disulfoton... 

Among the requirements for registration of pesticides in the United States, the 1978 guidelines proposed by the U.S. Environmental Protection Agency (3) list general metabolism studies "in at least one mammalian species, preferably the laboratory rat. .." Although similar tests have been conducted on other terrestrial species with increasing frequency, the small rodents have remained the principal source of metabolism data from intact animals. 

Decision and emergency order suspending registrations of pesticide products containing 1,2 dibromoethane for use as a grain and spot milling fumigant... 

On July 3, 1975, the Agency promulgated final regulations, 40 CFR part 163, Subpart A (10). These regulations established the basic requirements for registration of pesticide products. 

Third, whenever possible, this communication needs to be interactive. In the registration of pesticides, legally mandated deadlines, the complexity of the assessment, the manifold assumptions needed to fully explore methods and their outputs, and the need to protect sensitive business information limits the degree to which stakeholders may always be able to participate interactively. Nevertheless, opportunities for meaningful interaction with stakeholders, especially those that can bring additional data or information to bear and can constructively review the process, will benefit practitioners. 

Intent to Cancel Registrations of Pesticide Products Containing Carbon Tetrachlori de... 

Extrapolation methods are used for various types of risk assessment. Methods may be used in the process of deriving environmental quality objectives, in the registration of new substances, and in the process of site-specific risk assessment. Suter (1993) called these approaches prospective (the former 2) and retrospective (the latter) risk assessments. The specific process in which extrapolation methods are used has implications for the concepts to be applied and the data to be used as input in extrapolation. Strictly described approaches are in place for the derivation of environmental quality criteria (EQCs) and the registration of pesticides and newly developed substances. The prescribed approaches for deriving EQCs can differ between jurisdictions. The approaches for retrospective investigations have more degrees of freedom. A characteristic of the latter approach is that the methods can make use of measured local exposure levels and can estimate local risk with known precision (or known uncertainty ). The latter is uncommon for EQCs. 

When a model-based extrapolation technique is unavailable, it may be possible to work along the axis of Figure 10.2 concerning the choice of data, that is, to choose for the use of physical models. With the term physical model, it is meant that the model itself consists of creating an experimental or observational situation that mimics the situation of concern. This option is often applied in the registration of pesticides, where microcosm, mesocosm, and/or field experiments are used to characterize the impacts of pesticides on nontarget species. When the physical models do not, in some aspects, resemble the situation of concern, 1 or several extrapolation steps may be needed. 

The proposed tiers are not obligatory but contain extrapolation tools that can be used differently in a number of situations and, in some cases, regulatory protocols, in which certain combinations of extrapolation methods are prescribed as methods that must be used for the assessment, such as in the formal registration of pesticides. The proposed tiered system is based on a scientific classification of the available extrapolation method types. With ideal data and concepts for extrapolation, this scheme may be expected to yield reduced degrees of overestimation of risk when moving up the tiers from Tier-0 to Tier-4 (i.e., risks are more precisely estimated in the higher tiers). 

U.S. Environmental Protection Agency, Guidance for Registration of Pesticide Products Containing Trichlotfon as the Active Ingredient, Washington, DC, 1984. 

FIFRA regulations control not only the safety of a chemical but also the labelling (application dosage, safety precautions, pest control, etc.). Registration of pesticides includes approval of label uses, setting of tolerances in foods and environmental and human safety. Registration of new pesticidal surfactants is very expensive and time consuming. 

Data on fate and transport, exposure, and effects of substances on humans and other organisms in the terrestrial compartment are normally obtained from the publicly available literature. Other sources of potentially relevant data for organisms in the terrestrial compartment include industry-generated data for the process of notification, registration of pesticides and other substances, and technical reports from research institutes. 

Economic incentives have not been used much in chemical safety (OECD 2009e). At the national level some countries use fees, and there are a few examples of taxes. The fees for registration of pesticides have worked as deterrents to the marketing of many pesticides. It remains to be seen whether the REACH registration in the European Union will have a similar effect for low production volume substances. 

---