A Scientific and Regulatory Update on NPEs for the Chemical Producers

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A Scientific and Regulatory Update on NPEs for
the Chemical Producers Distributors
Association

• Dr. Ellen Mihaich
• May 12, 2004

2
APERC Member Companies

• Rohm Haas
• Company
• Schenectady
• International, Inc.
• The Dow Chemical
• Company

• Dover Chemical Corp.
• Crompton Corp.
• Great Lakes
• Chemical Corp.
• Huntsman LLC
• Rhodia Inc.

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Presentation Overview

• Background on Nonylphenol (NP) and Nonylphenol
  Ethoxylates (NPEs)
• Scientific Update on NP/NPEs
• Regulatory Update on NP/NPE

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Background
5
Chemical Structures
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Background .

• End use applications
• Household, Industrial, and Institutional Cleaners
• Industrial Processing
• Emulsion Polymerization
• Paints and Coatings
• Textiles
• Pulp and Paper
• Agrochemicals

Nonylphenol Ethoxylates
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Use and Disposal Patterns Application
Disposal Practice

• Institutional and household cleaning products
• Industrial processing aids
• Paints and Coatings
• Pesticide formulations

• Down the drain to treatment plant
• On-site treatment or pre-treatment
• Remain encapsulated
• Sprayed onto foliage and soil

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Why the Interest in NP/NPE?

• Interest in NP/NPE biodegradability in the early
  1980s
• Connection of NP to the Endocrine Issue in the
  early 1990s
• High volume, ubiquitous chemical

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Scientific Update
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NP/NPE are Biodegradable

• NP and NPE are inherently and ultimately
  biodegradable when tested according to OECD 301B
  and OECD 301F assays (Staples, C.A. et al, 2001
  and 1999, Maguire 1999)
• NP/NPE are not persistent in accordance with
  established national and international criteria

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Degradation Pathway

• Shortening of the EO chain proceeds via formation
  of carboxylated intermediates (NPEC)
• Oxidation continues until EO chain shortened to
  NPE1,2
• Enzymatic opening and mineralization of aromatic
  ring
• NP/NPE fully biodegrade to CO2 and H2O, even the
  aromatic ring portion

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NP/NPE are Not Bioaccumulative

• NP/NPE are rapidly metabolized and excreted by
  fish and humans
• NP/NPE are not considered bioaccumulative in
  accordance with established national and
  international criteria
• Governmental risk assessments have concluded that
  environmental exposure of NP/NPE does not present
  a risk to humans

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APERC Ecotoxicity Data Review and Relative Hazard
Assessment

• Critically reviewed chronic toxicity data
• Chronic Values (ChV) calculated
• ChV plotted according to EO chain length by
  endpoint
• Species sensitivity distribution
• Exposure compared to hazard for cumulative risk

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Chronic Values for Fish (F), Invertebrates (INV)
and Algae (ALG) by NPEx

• Survival ChV
• x Growth ChV
• ? Repro ChV

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Species Sensitivity Distribution NP
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Aquatic Levels of NP/NPE in the United States

• US 30 Rivers Study (Weeks, J.A. et al, 1996)
• Conducted in coordination with US EPA
• NP NPE1,2 0.1 µg/L,
• NPE3-16 2 µg/L
• National Reconnaissance Survey (Kolpin et al,
  2002)
• Sponsored by the US Geological Survey
• NP, NPE1,2 medians 0.8 to 1.0 µg/L

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APERC Preliminary Terrestrial Risk Assessment for
NP in Biosolids

• NP and NPEs biodegrade adequately in biosolids
  added to soil under normal conditions of use
• NP has little potential to migrate into
  groundwater
• Maximum amount of NP and other NPE biodegradation
  intermediates in soil from biosolids application
  is more than 10 times lower than NP
  concentrations that have no effect on earthworms
  or other soil organisms, or on plant crops such
  as soy, sorghum or sunflower.

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Plant Uptake Studies

• Utah State University
• Phase I - Hydroponic Uptake Study
• 14C found primarily in roots indicating
  essentially no plant uptake
• Manuscript in review
• Phase II Soil Uptake Study
• Study still in progress
• Initial results are consistent with the
  hydroponic study

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Summary and Conclusions

• Numerous aquatic studies with NP/NPE/NP ether
  carboxylates (NPEC) with dozens of species have
  been conducted
• The available database of conventional chronic
  studies is adequate to address the ecotoxicity of
  the various biodegradation intermediates of NPE
  surfactants including endocrine effects

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Summary and Conclusions

• Aquatic toxicity not endocrine issues drive risk
  assessment conclusions
• Commercial NPEs are not estrogenic
• NPE degradation intermediates do not have
  equivalent toxicity (i.e. NPE is less toxic than
  NP)

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Summary and Conclusions

• Typical concentrations of NP/NPEs in the
  environment are very low
• NP is a minor degradation intermediate
• Cumulative exposure assessment compared to hazard
  shows concentrations in the surface water
  generally do not exceed a safe level

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Regulatory Update
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European Union

• Marketing and Use Directive 26th Amendment to
  Directive 76/769/EC
• Restricts the marketing and use of NP and NPE in
  certain applications
• Published in the EU Official Journal (July 17,
  2003.)
• 18 month transition period for the implementation
  of regulations at the national level

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European Union

• Marketing Use Directive - NP/NPE
• Affected applications include co-formulants in
  pesticides and biocides
• However, the restriction respects the validity
  of existing national authorizations of plant
  protection products or biocidal products
  containing NPE as a co-formulant, which have been
  granted before the entry into force of this
  Directive, until they expire

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Canada

• Environment Canada Proposed Pollution Prevention
  Planning for Certain Products (June 2003)
• Soap and Cleaning Products
• Wet textile Processing
• Pulp and Paper Processing
• Risk Management Goals for these Products
• 50 NP/NPE Use Reduction by 2007
• 95 NP/NPE Use Reduction by 2010

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Canada

• Pest Management Regulatory Agency (PMRA)
• Circulated a letter to pest control product
  producers and adjuvant producers with products
  containing more than 1 NPE (Feb. 2003)   
• Requested that they submit a plan to substitute
  NPE with less harmful alternatives by May 25,
  2003

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United States

• EPA Proposed WQC for NP (Jan. 2004)
• Acute Freshwater 27.9 ppb
• Chronic Freshwater 5.9 ppb
• Acute Saltwater 6.7 ppb
• Chronic Saltwater 1.4 ppb

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United States

• Proposed NP WQC values are greater than the
  levels of NP generally found in US waters
• The 30 Rivers Study
• Statistically designed monitoring study conducted
  by APERC in conjunction with EPA (1990)
• USGS Reconnaissance Study (2001)
• Effluent dominated streams

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United States

• WQC values for NP are scheduled to be finalized
  by EPA in late 2004.
• However, the values will not represent
  enforceable regulatory limits for industry or
  municipal wastewater treatment facilities until
  they are adopted or incorporated into state level
  water quality standards (WQS).
• The timing for implementation of the WQS for NP
  will vary by state.

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United States

• EPA Endocrine Screening and Testing Program
• EPA concluded that it is not practical at this
  time to sort and prioritize the universe of
  chemicals as defined by EDSTAC
• EPA will require chemicals to be screened in
  batches
• Legal mandate and exposure will be the primary
  selection factors
• Pesticides and inerts

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United States

• EPA Inert Reassessment Program
• Surfactants Workgroup - CPDA
• Extensive mammalian and environmental fate and
  effects data available for NPE