Making Chemicals Child Safe

1
Making Chemicals Child Safe

• Lynn R. Goldman, MD, MPH
• Professor, Environmental Health Sciences
• Johns Hopkins Bloomberg School of Public Health
• May 10, 2005

2
Childrens health protection FQPA

• Clear deadlines for action by EPA
• All existing pesticide food standards must be
  assessed to assure
• Children are safe from hazards of individual
  pesticides across all (aggregate) exposures.
  Health-only standard of reasonable certainty of
  no harm
• Children are safe from hazards of multiple
  pesticides with cumulative risks
• An additional 10X factor applied unless
  childrens hazards AND exposures have been taken
  into account
• Rewards for bringing safer pesticides to market

3
Childrens health protection TSCA

• No provisions specifically directed at children
  but rather
• An unreasonable risk standard that includes
  economic benefits to those who manufacture,
  process and otherwise use chemicals
• No requirement to protect children and other
  sensitive populations
• No deadlines or specific expectations for action
  and a least burdensome requirement that has
  killed management of even the riskiest
  chemicals (e.g. asbestos) under TSCA
• Significant barriers for bringing newer safer
  chemicals to market

4
New chemicals approvals-TSCA

• Only chemical structure and physical
  characteristics are supplied
• Agency uses Structure Activity Relationships and
  physicochemical properties for most decisions
• However, Agency can require additional
  information or issue Significant New Use Rules
  for new chemical uses

5
Assessment of existing chemicals - TSCA

• In 1976 70,000 existing chemicals grandfathered
  into use and placed on the inventory between
  1,500-3,000 have been reviewed by EPA as new
  chemicals every year since
• The inventory has numerous inaccuracies and is
  only partially updated
• To required testing EPA must write a test rule
  that contains a finding of unreasonable risk
  (can be based on exposure) EPA must meet a heavy
  burden to justify testing
• 2,500 chemicals/groups involved in the
  industry/EPA voluntary HPV program
• Generally, ignorance about hazard (and risk) is
  rewarded since the law presumes that chemicals
  are safe unless proven otherwise by the EPA

6
Chemical Security

• Numerous exceedingly hazardous chemicals can be
  purchased over the internet
• Government has not required that chemical
  facilities are not secure from terrorist attacks
  (although some companies have taken action
  voluntarily) even when children live in close
  proximity to them
• Chemical transport has not been secured .

7
Right to know access to information

• In 1998, more than 65 of the information
  filings directed to the Agency through TSCA were
  claimed as confidential.
• Submissions under the former Inventory Update
  Rule show that about 20 of facility identities
  were claimed as confidential.
• In 1998, 40 of Section 8(e) substantial risk
  notices had chemical identity claimed as
  confidential.
• States cannot receive CBI filings under the
  statute, yet many chemical risk management
  decisions in this country are done at the state
  and local level

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Why this is a concern for childrens health?

• Children are often more highly exposed to
  chemicals in the environment, via diet,
  inhalation, crawling on the floor, mouthing hands
  and objects in the environment, and route such as
  transfer from other to baby in utero or in breast
  milk
• Children are often more susceptible
• Windows of exposure during development cause
  susceptibly to irreversible effects like birth
  defects, neurobehavioral outcomes, other
  developmental alterations, cancer.
• Parents are not aware that the products in their
  homes are made with chemicals, many of which have
  not been assessed at all for risks to children

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Making chemicals child safe

• Clear expectations of EPA shift the burden of
  proof to industry
• Reward information/innovation/safer substitutes
• Adopt child specific safety standards
• Prioritize to protect kids
• Strengthen enforcement
• Promote right to know
• Support international efforts

10
Clear expectations

• No exposure to chemicals that do not meet core
  information requirements.
• The burden of proof is shifted industry is to
  demonstrate safety of a chemical by supplying
  required data (as described below).
• A process with deadlines and commitment to
  timeliness, and mechanisms for ensuring that
  protective measures are adopted by default if
  action is not taken on a timely basis.

11
Reward information and innovation

• Rewards for generation of information about
  chemicals and exposures, through more rapid
  approvals (and penalties for failing to provide
  information, such as losing market access)
• Support and rewards for research, development and
  innovation, and for safer substitutes through
  exemptions and more rapid approvals for much
  safer substitutes..

12
Child safety standards

• An additional safety margin for children, to
  assure a parents right to a healthy child.
• EPA to establish protocols for hazard and
  exposure assessments that explicitly consider
  children and their most sensitive and vulnerable
  health effects.
• Require consideration of aggregate and cumulative
  risks of chemicals..
• Approval of a chemical should not be in
  perpetuity. Chemicals should be re-assessed
  periodically to take into account new science.

13
Prioritization

• A transition process that prioritizes review and
  approval of existing chemicals.
• Priority is to be given to the worst first --
  after consideration of
• Childrens exposure pathways
• Biomonitoring data
• Cancer, developmental and reproductive effects
• Production volumes
• Bioaccumulative or environmental persistence
  properties
• Use patterns

14
Enforcement

• Strong enforcement provisions including routine
  inspections and random audits of facilities and
  laboratories.
• Strong citizen suit and petition provisions, and
  clear deadlines for action written into the law.
• Routine EPA review and monitoring of the
  facilities conducting the studies (such as
  regular inspections and randomized data audits
  with severe penalties).

15
Biomonitoring

• Require generation of biomonitoring data and
  methods for interpreting and understanding
  biomonitoring data biomonitoring must be
  scientifically standardized and collected under
  guidelines established by EPA.

16
Right to know

• Limit the use of confidential business
  information (CBI) protection such that health
  and environmental information should not be be
  declared CBI.
• Strengthen role of states and other Federal
  agencies including NIEHS, NTP, and CDC, in
  biomonitoring and in assessment of hazards of
  chemicals.

17
International commerce

• Management of chemicals in commerce
  internationally In this regards, the U.S. should
  be a leader and a good partner in international
  efforts for sound management of chemicals,
  including
• Ratify Stockholm Convention on Persistent Organic
  Pollutants (POPs)
• Ratify Rotterdam Convention on Prior Informed
  Consent (PIC)

18
Making chemicals child safe (conclusion)

• EPA needs clear requirements and regulatory
  authority that requires placing a high priority
  on protecting children's health (as defined
  above) and on protecting other vulnerable
  subpopulations.
• A strong safety standard health protection of
  children should be the basis for chemical
  regulatory decisions.