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Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document

proteins are contained within corn plant cells which essentially eliminates or reduces exposure routes to negligible. Oral exposure, at very low levels, may occur from ingestion of processed products and drinking water. Worker exposure to the Cry protein via seed dust is also expected to be negligible because of the low amount of protein expressed in seeds of the transformed plants. Taken in total, these data allow the Agency to make a determination that for human health, there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the Cry1Ab and Cry1F proteins and the genetic material necessary for their production. Thus, EPA concludes that there are no adverse effects on human health from the use of Cry1Ab or Cry1F proteins expressed in corn.

b. Bt Cotton

Tests have shown no toxicity to mammals from the Cry1Ac protein; the protein is readily digestible in gastric fluids and are non-glycosylated, the protein is inactivated by typical food processing, and anticipated exposure to the protein from farm workers are negligible. The Cry1Ac protein acute oral toxicity data submitted demonstrated no effects at the relatively high dose level of 5,000 mg/kg. Cry1Ac protein is degraded between two minutes and seven minutes by gastric fluid in vitro. Exposure via the skin or inhalation is not likely since the Cry1Ac protein is contained within cotton plant cells which essentially eliminates or reduces exposure routes to negligible. Oral exposure, at very low levels, may occur from ingestion of processed products and drinking water. Worker exposure to the Cry protein via seed dust is also expected to be negligible because of the low amount of protein expressed in seeds of the transformed plants. Taken in total, these data allow the Agency to make a determination that for human health, there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the Cry1Ac protein and the genetic material necessary for its production. Thus, EPA concludes that there are no adverse effects on human health from the use of Cry1Ac protein expressed in cotton.

2. Ecological Assessment

The ecological assessment section of this document focuses heavily on evaluating the impacts of Bt plant-incorporated protectants on non-target species. EPA recognizes that there has been considerable public concern about the potential for these products to have significant and unintended consequences for non-target species such as the monarch butterfly. This assessment relies not only on the original data developed in support of the Bt registrations, but additionally, on data developed and submitted to EPA under a Data Call-In (DCI) requirement as well as recently published literature. Specific data is cited for concerns related to gene outcrossing and weediness, fate in soils and potential indirect effects on soil biota, direct effects on non-target species including mammals, avian and aquatic species, insects, lepidoptera, and endangered or threatened species.

Since the September 2000 version of the risk and benefits assessments and the October 2000 SAP meeting, this section has been updated to indicate 1) Collembola and earthworm tests are no longer necessary to evaluate risk to soil non-target organisms from Bt crops, 2) additional Bt corn avian

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