Better Living Through Chemicals
Regulating Toxic Substances and Pesticides
FIFRA and TSCA
Things to think on:
Precautionary principle: that we should err on the side of safety
Or, full steam ahead: that we should not over-regulate without proof of harm
What do you hear about ‘good science’ vs. ‘junk science’?
Costs and benefits:
What is efficient policy and efficient regulation?
Policy that weighs costs and benefits of regulation, we choose least costly option
Efficient environmental health policy:
It would be inefficient to introduce unnecessary costs to regulate actions, possible toxics
How much for your mother?
This week: regulating toxic substances and pesticides … structure of regulation …
Environmental law and public health …
Clean air and clean water – partly about protecting environment, partly about protecting public health
How are publichealth and air/water quality related in policy form?
Toxic substances affect air and water, but also enter our bodies through our industrially produced foods …
In dealing with toxics, we think about
degree of toxicity
path of exposure
harm from exposure
for air, exposure is from breathing, regional air movements, there are ‘pockets’ of air that are dirtier than other pockets of air
for water, exposure from immersion, or eating things that have been in the water or watered with the water, or drinking … paths may be interrupted by treatment
for toxics, exposure pathways may be through air, water, food, soil
Legal categories:
Toxic Substances Control Act (TSCA) (1976): review and regulate the invention of toxics (proactive)
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (1971)
Pesticides: insecticides, rodenticides and herbicides
Food Quality Protection Act of 1996 amended both FIFRA and Federal Food, Drug and Cosmetic Act (FFDCA) 1970 to provide a more comprehensive and coordinated protective regulatory scheme for pesticides
TSCA and FIFRA differ from (health standards portion of) CAA and CWA in that they use a risk-cost balancing approach to the regulation and use of toxic substances
Cost-risk and environmental effects …
Pesticides: safety of human food supply, agricultural worker safety
FIFRA amendments in 1972 established the basic structure of the present law
Basic Structure of FIFRA
Purposes: regulating pesticides
Registration and evaluation
Suspend, cancel or restrict pesticides posing a risk to the environment
Enforcement
Registration:
Company that wants to manufacture, formulate, import or distribute a pesticide must register it
Requirement applies to newly discovered chemicals and new combinations of chemicals
Submit a complete formula, proposed label, description of the tests made and the results of those tests
EPA to register if:
composition warrants the claims made
labeling complies with requirements of the Act
will perform its intended function without unreasonable adverse effects on the environment
when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment
Issues:
Trade secrets (corporate information protections)
Generating the data required for registration is a major cost
EPA allowed to use test data supplied by one manufacturer to register the product of another manufacturer if its about the same ingredients, with compensation (from one mftr to other manufacturer)
Permits release of trade data under some circumstances
1984, Supreme Court ruled that there was a property interest in this data
The Delaney Clause vs. ‘some risk’
Delaney Clause: NO RISK, or no adding carcinogens to food …
Delaney Clause was repealed in 1996 in the Food Quality Protection Act
Used to prohibit the addition of any substance to foods that was a carcinogen
This is no longer the law
What is a carcinogen? Some foods are carcinogens, so the Delaney Clause criticized as irrational – adding minor carcinogens to major carcinogens didn’t seem to make a difference …
Some research suggests a link between heavy meat diet and cancer – other research suggests that eating higher levels of chili peppers (capsicum containing foods) reduces cancer risk … foods themselves can enhance or reduce the risk of cancers
Outline of TSCA
Purpose
Elements
Comparison of FIFRA and TSCA
Purpose of TSCA
Regulatory control over toxic substances that are not controlled under FIFRA
That is, that are not applied as pesticides
Chemicals that may present a significant risk to human health or the environment
TSCA regulates substances like PCBs, asbestos, lead in household paint, formaldehyde etc
Elements:
Screen new chemicals
Require testing of (risk) chemicals
Gather information about existing chemicals
Limit or prohibit the manufacture, use, distribution and disposal of chemicals
Better Living Through Chemistry
Nearly 2000 new chemicals enter the TSCA process each year
Screening:
Premanufacture Notice:
The EPA is to assess new chemicals before they are manufactured
Any person who intends to manufacture new chemicals must file a notice before
(for new chemicals only, or major changes in use or application)
exemptions:
- things regulated under FIFRA
- chemicals used solely for R&D
- existing chemicals
the EPA has a list of TSCA registered chemicals, the TSCA inventory – these are the chemicals that have passed the notification process
- if it isn’t on the list, it is new
Screening information must include:
- common or trade name of the substance
- chemical identity
- estimated production levels
- proposed use of chemical
- estimated levels of exposure and number of workers involved
- by products, impurities and related products
- available test data on health and environmental effects if they have them
- description of known or reasonably available test data
No independent testing requirement at this stage
Approval of the Premanufacture Notice (PMN)
- EPA required to review the PMN within 90 days
- If no action by EPA, company may begin
o Must file Notice of Commencement
- if EPA has questions, may delay by 90 days
o for good cause
o or, for insufficient data to permit a reasoned evaluation
- the EPA may limit or delay, or condition
o for further data
- the EPA may limit or delay if
o the substance presents or will present an unreasonable risk of injury to health or the environment
o but must have affirmative evidence ‘beyond the theoretical’
- in many cases, the EPA enters an agreement that restricts (regulates) the production, use, disposal, or exposure, and this is binding on subsequent manufacturers
Testing Requirements
authorizes EPA to require that manufacturers develop test data
if there is evidence that the chemical may present unreasonable risk to human health or harm to the environment
requires EPA to make a risk determination of both toxicity and exposure before it can order testing
Factors that EPA must consider to make a risk determination
knowledge of chemical’s physical and chemical properties
related chemicals
data from inconclusive tests
case history data
TSCA requires the EPA to undertake formal rule making in order to require testing
Formal rulemaking takes two years
Interagency Testing Committee – representatives of eight federal agencies
may recommend substances for priority consideration
by cancer, gene mutations, birth defects
within one year after ITC designates a chemical, the EPA must propose a test rule or publish reasons
in early years, EPA consistently failed to meet the one year deadline
sued by NRDC
then EPA attempted a voluntary testing program, but TSCA requires formal rule-making, they were sued by NRDC again, voluntary agreements are illegal under TSCA
Comparison of FIFRA and TSCA
TSCA and FIFRA regulate the chemicals themselves rather than emissions to the environment (like CWA, CAA)
Both mandate a risk-benefit standard
Upfront testing requirements for new chemicals
FIFRA Yes TSCA No
Prohibition without approval (registration)
FIFRA Yes TSCA No
Burden of initial proof
FIFRA Mfturer TSCA EPA
Costs of registration and testing
FIFRA $5-7 Million TSCA $1,300-7,500
Ease of EPA to gather information
FIFRA easier TSCA harder
Can withhold registration (burden of proof, must issue rule)
TSCA has been called the most complex, confusing and ineffective of all federal environmental protection laws …
May actually discourage premarket testing of new chemicals.
Burden of proof, standards of proof, use of evidence
Information that the manufacturer must provide
Find the tolerance for that pesticide
levels of residues likely to result (on food)
data necessary to determine ‘safe’ levels
Data and health tracking:
legislation passed last year to fund health tracking for environmentally-related diseases
Health issues that have an environmental component:
Particular kinds of cancers and leukemias, asthma
would require the CDC and the states to cooperate in tracking usable data