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Federal
Register Search the Federal Register for rules, regulations,
and notices since 1994.
FDA Guidance Documents Guidance documents represent the Agency's current thinking
on a particular subject
The
EPA maintains lists of the latest OPPTS harmonized guidelines for the conduct of Developmental Toxicity, Reproductive Toxicity
and Developmental Neurotoxicity Studies. The Series 870 - Health
Effects Test Guidelines can be found as either Public
Drafts or Final
ICH
Guidelines The tripartite harmonised ICH guideline was finalised
in June 1993. These guidelines give guidance on tests for reproductive
toxicity in order to better reflect human exposure to medicinal
products and allow more specific identification of stages at
risk. These files are posted on the Website of the International
Federation of Pharmaceutical Manufacturers Associations.
OECD
Guidelines This OECD site lists the current OECD guidelines for
the Testing of Chemicals. Current guideline texts are sold on
CD ROM or via paper copies which can be ordered from this Website.
Drafts of new or revised guidelines are available for downloading.
California
Proposition 65 Documents This site contains documents from the California EPA
including the California List of Chemicals Known to the State
to Cause Cancer or Reproductive Toxicity.
Pestlaw Review of
the U.S. EPA Guidelines for Reproductive Toxicity Risk Assessment
The
Guidelines for Reproductive Toxicity Risk Assessment discuss
the scientific basis for concern about exposure to agents that
cause reproductive toxicity and describe the principles and
procedures to be followed in conducting risk assessments for
reproductive toxicity. They include the female (non-pregnant
and pregnant) and male reproductive systems.
The Guidelines for Reproductive Toxicity Risk Assessment discuss the scientific basis for concern about exposure to agents that cause developmental toxicity and describe the principles and procedures to be followed in conducting risk assessments for developmental toxicity.
U.S.
EPA Food Quality Protection Act of 1996 On
August 3, 1996 the Food Quality Protection Act (FQPA) of 1996
became law. Among other things, this law is intended to make
sure that sensitive subpopulations, especially infants and children,
will not become ill from consuming pesticide-treated foods.
The following links provide information on 1) the inclusion
of an additional 10X safety factor for children (above and beyond
the 10X factor traditionally assigned to intraspecies variation)
in EPA risk assessments for agricultural chemicals, 2) the home
page for the EPA's EDSTAC advisory committee which was charged
with developing an endocrine disrupters screening and testing
program, and 3) the home page for the parallel effort of the
OECD to harmonize guidelines for testing chemicals for the potential
to cause endocrine disruption.
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