Common use of Aggregate Exposures Clause in Contracts

Aggregate Exposures. In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non- occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. The primary route of exposure to BCETMD copolymer from its use as an inert ingredient in pesticide products applied to cotton and wheat crops would most likely be through consumption of food to which pesticide products containing it as an inert ingredient have been applied, and possibly through drinking water (from runoff). The use of this chemical is limited to pesticide formulations applied to cotton and wheat crops only, therefore, there are no residential uses of this chemical, and thus no residential (dermal and inhalation) exposures are expected. No adverse effects attributable to a single exposure of BCETMD copolymer were seen in the toxicity database. Therefore, an acute dietary risk assessment is not required. There are no data provided regarding BCETMD copolymer residues in food or any other nonoccupational exposures to BCETMD copolymer. In the absence of actual residue data for BCETMD copolymer, the Agency performed a chronic dietary (food and drinking water) exposure assessment for BCETMD copolymer when used as an inert ingredient in pesticide formulations applied pre-harvest to cotton and wheat using a series of very conservative assumptions. This exposure assessment was calculated based on the following assumptions: 1. BCETMD copolymer would be used as an inert ingredient in all food use pesticide formulations applied pre- harvest to cotton and wheat crops. 2. A hundred percent of all cotton and wheat crops would be treated with pesticide products containing BCETMD copolymer. 3. BCETMD copolymer residues would be present in all cotton and wheat crops at levels equal to or exceeding the highest established tolerance levels for any pesticide active ingredient. 4. A conservative default value of 1,000 parts per billion (ppb) for the concentration of an inert ingredient in all sources of drinking water was used. This approach is highly conservative as it is extremely unlikely that BCETMD copolymer would have such use as a pesticide product inert ingredient and be present in cotton and wheat food commodities and drinking water at such high levels.