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Lecture #7
Julie King Baylor University Environmental Law
Undergraduate 4

Additional Law Flashcards




Toxic substances
***refers to something directly poisonous to humans, but the Toxic Substances Control Act does not define "toxic"
***Some acts regulate toxins
***toxins are generally more harmful at lower concentrations and may potentially bioaccumulate
***according to EPA, a toxic substance is any chemical or mixture that may by harmful to the environment and to human health if inhaled, swallowed, or absorbed through the skin
***According to OSHA, toxic substances are defined as those chemicals which are capable of causing harm. The term "chemicals" includes dusts, mixtures, and common materials such as paints, fuels, and solvents
Risk assessments
***EPA and OSHA must determine and balance risk involving toxic substances
***risk assessment--process of characterizing potentially adverse consequences, preliminary to risk management
Risk management
process of making policy decisions based on assessed risk
Hazard identification methods
***comparisons of molecular structures
*Comparisons to known carcinogens
***Short-term studies
*Effects in single cell organisms
*If mutation, further study
***Animal bioassay data
*looking for consistent positive results among both sexes, strains, and species
***Epidemiological data
*Looking for positive association between exposure and disease--limited reactive vs. proactive method
Prevalence of chemicals
***15 fold increase in production of synthetic organic chemicals from 1945-1985 (from 6.7 million tons/year to 102 million tons/year)
***More than 80,000 chemicals in everyday use worldwide (1,500 new ones added each year)
***Toxic effects of a chemical may not be known for years
***Legal system and govt. agencies are charged with responsibility of making sure public is safe from chemicals while encouraging development of helpful chemicals
Toxic Substances Control Act (TSCA)
***primary federal law designed to regulate toxic substances
***enacted in 1976 with 3 objectives
*data on environmental effects of chemicals must be developed by industry
*govt. must have adequate authority to prevent unreasonable risk of injury to health or the environment, particularly imminent hazards
*govt. authority must be exercised so as to not create unnecessary barriers to technology
***addresses old and new chemicals separately
***EPA listed all chemicals used or produced in U.S. between 1975-1979 and categorized those chemicals as high priority or not in 1979
***High priority chemicals were subject to further testing; no more than 50 chemicals can be listed as high priority within a 12 month period
***high priority list updated every 6 months
TSCA new chemicals
***new chemicals regulated separately
***premanufacturing notice(PMN) must be submitted 90 days before manufacture or importation of any new chemical for sale or use in commerce
***EPA receives between 1000-2000 PMNs per year
***PMN contains information about chemical name, identity, molecular structure, trade names, byproducts, and details about maximum quantities to be manufactured, where it will be manufactured
***EPA publishes notice of receipt of all PMNs within 5 days of receipt
***EPA has 45 days to take action to limit production; EPA must select "least burdensome control"
***manufacturer can do as it proposed within expiration of a 90 day period (unless EPA takes action to restrict)
***any substances used to kill rodents, insects, fungi, bacteria, and weeds
***special category of toxic substances, and are regulated separately
***public first became aware of major health issues with pesticides as a result of Rachel Carson's "Silent Spring"
***Approx. 165 pesticidal chemicals are classified by EPA as known, probable, or possible carcinogens
***Many pesticides, such as DDT, have been taken off the market as a result of concerns or proven harm to wildlife or human health
***through natural selection, newer, stronger strains of the organism can evolve
***pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which was passed in 1947
***Pesticides were the first toxic substances to cause public concern, and were the first to be regulated
***enacted in 1947
***all pesticides must be registered and labeled before they can be distributed in the U.S.
***EPA will register pesticides if
*the pesticide's composition warrants the proposed claims for it
*it is properly labeled
*it will perform its function without unreasonable risk to people and environment
*it will not cause unreasonable risk to the environment
***a pesticide can be registered for a general or restricted use
***general use is most desirable because a general use pesticide meets the standards set by EPA and can be sold in any quantity
***restricted use pesticides have the potential to have an unreasonably impact
***registration lasts 5 years and notice of cancellation will be published in the Federal Register if no request for renewal is received
***EPA occasionally grants conditional registration for less than 5 years when the pesticide is substantially similar to another
***EPA can deny registration, but applicant has 30 days to address
Pesticide registration
***conditional registration (less than 5 years)
*when pesticide is substantially similar to a currently used pesticide
*no significant harm would result from pesticide
*conditional registration can be granted for time needed to submit data
***reregistration applies to pesticides registered before November 1984 because those usually do not meet today's standards
***EPA can cancel a pesticide's registration if it poses an unreasonable risk
*issues of disposal, reimbursement
*dumping on foreign markets--food source for U.S.
Food safety
***EPA is required to set tolerance levels for pesticide residue on food through the Federal Food, Drug, and Cosmetics Act (FFDCA)
***tolerances are enforced by FDA and USDA/Food Safety Inspection Service for meat, poultry, and some egg products
***FDA is responsible for food packaging
***inconsistencies between FIFRA and FFDCA led to the passage of the Food Quality Protection Act in 1996
***EPA must also explicitly address infants and children
Food Quality Protection Act of 1996 (FQPA)
***most comprehensive and historic overhaul of the nation's pesticide and food safety laws in decades. The FQPA amended FIFRA and FFDCA by fundamentally changing the way EPA regulates pesticides
***Some of the major requirements include stricter safety standards, especially for infants and children, and a complete reassessment of all existing pesticide tolerances
***FQPA created a single, health-based standard for all pesticide residues in food
***FQPA mandates that pesticides be tested for endocrine disruption potential
International regulation
***UN's Food and Agriculture Organization created a voluntary procedure in 1989
*country acting to ban a pesticide would report ban to UN/FAO
*UN/FAO would report to importers
*Importing nation notifies UN/FAO of intent to cease or continue receiving product
***Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Prior Informed Consent/PIC)--treaty signed in 1998 that requires PIC parties to provide export notification
***PIC also created labeling criteria for exporting parties
***After receiving its 50th ratification, treaty went into effect in 2004
***U.S. has not ratified PIC, but has stricter requirements in place
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