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					Toxic and Hazardous Substance Control

Why Regulate Pesticides?
Over one billion pounds of pesticides are applied annually in the
  U.S. Pesticides cause significant environmental impacts:
• Acute and chronic health effects among workers in
  manufacturing process;
• Health effects on third-parties due to accidents in
  manufacturing and exposure;
• Health impacts to applicators and farmworkers during
  application
• Health impacts to consumers, via pesticide residues
• Contamination of surface waters from farm run-off
• Contamination of groundwater due to leaching
• Contamination to environment due to improper disposal of
  unused pesticides and containers.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

Chemical pesticides have been subject to regulation since
  Insecticide Act of 1910.
      •Act protected consumers (farmers) from ineffective
      products and deceptive labeling.
      •No federal registration or safety requirements.
      •Pesticide use was very low prior to WWII.

In 1947, The Federal Insecticide, Fungicide, and Rodenticide
   Act (FIFRA) enacted, requiring pesticide registration and
   some labeling requirements. Like predecessor, still mostly
   concerned with product effectiveness.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

Three major defects in 1947 FIFRA:

• Registration was a mere formality since Sec. Of Agriculture
  couldn‟t refuse a registration (register “under protest”).

• No regulatory control over use of chemical after distribution.

• Only legal recourse was for misbranding or adulteration, with
  the burden of proof falling on the federal government.
Toxic and Hazardous Substance Control

Rachel Carson‟s Silent Spring

“The more clearly we can focus our attention on the wonders
  and realities of the universe about us, the less taste we shall
  have for destruction.”


                                            - Rachel Carson, 1954
Toxic and Hazardous Substance Control

The Regulation of Pesticides

1962: Rachel Carson‟s Silent Spring published, best-seller for
  over a year.

• Her research revealed that DDT and other chemicals used to
  enhance agricultural productivity were wreaking havoc on the
  environment.
• Pesticide industry challenges book and author.
• CBS special on Carson‟s book, corporate sponsors bail.
• Challenges notions of benevolent science and controlling
  nature.
Toxic and Hazardous Substance Control

Carson‟s Silent Spring

• Carson dies of breast cancer two years after Silent Spring.
• In 1992, panel selected book as most influential of past fifty
  years.
• Credited for establishment of EPA, grassroots environmental
  movement.
• Credited for saving bald eagle and peregrine falcon from
  extinction.

NOTE: Since Silent Spring, agricultural use of pesticides has
  doubled (to 1.1 billion tons a year). Pesticide production has
  increased 400%.
Toxic and Hazardous Substance Control
The Regulation of Pesticides

In 1964 Amendments to FIFRA, USDA persuades congress to
   remedy two of three defects:
• Secretary of Agriculture now has authority to refuse to
   register a new product or to cancel a registration of an
   existing registration.
• Burden of proof now falls on the chemical manufacturer.

Improvements in the law were mostly on paper, as USDA‟s
  Pesticide Registration Division was understaffed and buried
  in bureaucracy.

USDA‟s conflict of interests: Promoting agriculture while
  attempting to regulate impact of pesticides (no EPA).
Toxic and Hazardous Substance Control

The Regulation of Pesticides

Environmental movement during 60s leads to wave of citizen
  suits pressuring USDA to enforce FIFRA requirements.

1970: Nixon creates EPA, which assumes bulk of USDA‟s
  responsibility in enforcing FIFRA.

EPA inherits USDA‟s Pesticides Division and resolves inherent
  conflict of interests.

FIFRA receives substantial amendments in 1972, 1975, 1978,
  1980, 1988, and 1996, producing a very complex statute.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

FIFRA requires all new pesticide products to be registered with
  EPA, involving:
     •Submittal of a complete formula.
     •A proposed label.
     •“Full description of tests made and the results thereof
     upon which claims are based.”

Very specific registration – separate registration for different
  applications of the same chemical, each supported by research
  data on safety and efficacy.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

EPA must approve the registration of a new pesticide if the
   following conditions are met:

1) Composition of active ingredient that warrants product‟s
    claim.
2) Labeling must comply with FIFRA requirements
3) Product will perform its intended function without
    unreasonable adverse effects on environment.
4) Widespread and common use will not generally cause
    unreasonable adverse effects on the environment (language
    added in 1972 amendments).
Toxic and Hazardous Substance Control

The Regulation of Pesticides

“Unreasonable adverse effects to the environment…”

Defined in FIFRA as meaning “any unreasonable risk to man or
  the environment, taking into account the economic, social,
  and environmental costs and benefits of the use of the
  pesticide.”

NOTE: Use of cost-benefit analysis.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

1972 Amendments allowed for EPA to regulate the use of
  pesticides.

Application techniques may vary. A pesticide may be suitable
  for dry land, but hazardous is applied in a marshy area. A
  chemical may be acceptable for use on one crop, but may
  leave a dangerous residue when applied to another crop.

Rather than revoking the registration of a chemical in response
  to one detrimental use, FIFRA allows for a review process,
  called a cancellation process.
Toxic and Hazardous Substance Control
The Regulation of Pesticides
Registration: Cancellation and Suspension
• Cancellation is used to initiate review of a substance
  suspected of posing a “substantial question of safety” to the
  public or environment. Allows for public participation.

• EPA can issue a suspension order – an immediate ban on the
  production and distribution of a pesticide.

• Mandated when a product constitutes an “imminent hazard”
  to the public or the environment.

• Suspension may be invoked at any stage of the cancellation
  process, or even before the process has been initiated.
Toxic and Hazardous Substance Control

The Regulation of Pesticides
Registration: Cancellation and Suspension
In rare instances, EPA may issue an emergency suspension,
   which immediately halts the production, distribution, sale,
   and use of a pesticide.

Registrant is given no notice or opportunity for an expedited
  hearing (ordinary suspension processes allow for this).

Registrations are for a limited, five-year period. Automatically
  expire unless interested party petitions for renewal and may
  be required to provide additional data indicating safety of the
  product.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

Federal Food, Drug, and Cosmetic Act: The Delaney Clause,
  enacted in 1958.

“…no [food] additive shall be deemed to be safe if it is found to
  induce cancer when ingested by man or animal…”

NOTE: Devoid of cost-benefit analysis.

In Les v. Reilly, 968 F.2d 985 (9th Cir. 1992), Ninth Circuit ruled
   that EPA had no discretion to permit food additives, including
   pesticides, if those additives were known to be carcinogenic.
Toxic and Hazardous Substance Control

The Regulation of Pesticides

Congress addressed the Delaney Clause in the Food Quality
  Protection Act of 1996. Congress did not repeal the clause,
  but it removed pesticide residues from the law‟s definition of
  „food additives.”

Delaney clause still applies to other food additives. But,
  concerning pesticides, EPA must now set a tolerance level for
  each substance and can register a pesticide as being “safe.”

“Safe” means that “there is a reasonable certainty that no harm
  will result from the aggregate exposure to the chemical
  residue. “Zero risk” approach abandoned re: pesticides.
Toxic and Hazardous Substance Control
Toxic and Hazardous Substance Control
Toxic Substances Control Act
ToSCA Overview

Prior to 1976, federal regulation of toxics consisted of an
   assortment of specialized provisions, most in statutes whose
   main focus was elsewhere.

Three policy goals of ToSCA:
1) Industry must provide data on environmental effects of
   chemicals.
2) Government should be able to prevent unreasonable risks of
   injury to health and environment.
3) Authority exercised so as “not to impede unduly or create
   unnecessary economic barriers to technological innovation”
   while accomplishing goals of the Act.
Toxic and Hazardous Substance Control

ToSCA Main Provisions

• Manufacturers and processors must test substances prior to
  commercial introduction.
• New production or significant new use  90-Day notification
  to EPA.
• EPA may delay or restrict manufacture of new chemicals if
  inadequate data to evaluate health and environmental effects.
• EPA may prohibit manufacture, processing, or distribution of
  chemical substances.
• Labeling requirements.
• EPA regulates toxic substance disposal if it poses
  unreasonable risk to health or environment.
Toxic and Hazardous Substance Control

ToSCA Main Provisions (cont.)

• EPA may obtain injunctive relief to protect public and
  environment.
• Reporting and record keeping requirements, as well as
  providing health and safety data.
• Notification to EPA of substances that pose a substantial risk
  of harm to health or environment.
• Authorize inspections and seizures of illegal chemicals.
• Allows for citizen suits.
• Whistleblower protection.
Toxic and Hazardous Substance Control

Toxic Substance Control

ToSCA does not apply to:
• Experimental and research chemicals produced in small
  quantities
• Firearms and ammunition
• Pesticides
• Food and food additives
• Drugs and cosmetics
• Meat, eggs, and poultry
• Tobacco and tobacco products
• Nuclear materials.
Toxic and Hazardous Substance Control

Toxic Substance Control
EPA‟s Attempted Asbestos Ban
In 1989, EPA issued final rule imposing a staged ban on most
   commercial uses of asbestos, invoking §6 of ToSCA and
   concluding that asbestos poses an unreasonable risk to human
   health.

Corrosion Proof Fittings v. EPA (947 F.2d 1201, 5th Cir. 1991):
Court held that EPA presented insufficient evidence to justify
  asbestos ban. Court cited §6 requirement to promulgate
  “least burdensome, reasonable regulation necessary to protect
  the environment adequately.”

How does EPA determine what is “least burdensome…”?
Toxic and Hazardous Substance Control

Toxic Substance Control
Cost-Benefit Analysis

• ToSCA imports FIFRA‟s “unreasonable risk” standard into its
  decision-making process, balancing economic costs against
  environmental benefits.

• Is it fair to balance the tangible economic costs against the
  uncertain environmental benefits?

• Fallacy of numeration: Human mind prefers the certain to the
  uncertain.
Toxic and Hazardous Substance Control

Toxic Substances Control
Testing and Pre-Market Notification
• ToSCA requires EPA to establish, by evidence, that chemical
  testing is necessary and then to set testing protocol.

• In contrast to FIFRA, the burden has shifted from the
  manufacturer to the federal government.

• Presumption of safety: EPA required to issue a rule before
  requiring testing distinguishes ToSCA from FIFRA, which
  mandates production of safety data prior to marketing.

• Who is in the best position to collect data, engage in chemical
  testing, establish protocols?
Toxic and Hazardous Substance Control

Toxic Substance Control
Testing and Pre-Market Notification

• Under ToSCA, EPA cannot require testing of every chemical,
  only those substances that EPA believes pose an unreasonable
  risk of harm to health and the environment.

• EPA must issue a rule requiring the manufacturer to perform
  testing. EPA must set the testing protocol.

• Manufacturers 90-day notice: EPA‟s inventory list, new
  chemicals, and pre-market notification.
Toxic and Hazardous Substance Control

Toxic Substances Control
Testing and Pre-Market Notification

If EPA has issued test order, test data must be submitted at the
   same time as pre-market notification. NOTE: Testing may
   often require several years.

EPA may block marketing of a chemical pending completion of
  testing. If there is insufficient data, EPA may issue a
  proposed order to block production. If manufacturer protests,
  EPA must obtain an injunction from federal district court.
Toxic and Hazardous Substance Control

Toxic Substance Control
Trade Secrets
Industry has an interest to protect its trade secrets from
   competitors, thus both FIFRA and ToSCA contain extensive
   provisions regarding confidentiality of information disclosed
   to EPA.

How can the public actively watchdog the registration process if
  it is denied access to critical data? Again, the balancing act.

Further research:
FIFRA: Ruckelshaus v. Monsanto, 467 U.S. 986 (1984)
ToSCA: Chevron v. Costle, 443 F. Supp. 1024 (N.D. Cal. 1978)
Toxic and Hazardous Substance Control

Toxic Substance Control

The Future of ToSCA

Statutes like ToSCA fail because there is insufficient political
    consensus:
1) To include provisions that are sufficiently clear and
    mandatory to be enforceable, and
2) If statutes are clear and enforceable, to fund and enforce them
    once enacted.

ToSCA‟s failures are rooted in politics, not in legalities.
Toxic and Hazardous Substance Control

Toxic Substance Control




For a successful technology, reality must take
  precedence over public relations, for nature cannot
  be fooled.
                                        -- Richard Feynman

				
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posted:10/16/2011
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