Nonylphenol and Its Derivatives

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• Nonylphenol and Its Derivatives
• A Regulatory Update
• Barbara Losey
• May 23, 2003

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Presentation Overview

• Antitrust Reminder
• European Union
• Canada
• United States
• APERC Resources

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• European Union

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European UnionNP/NPE

• EU Risk Assessment on NP (April '01)
• Exposure estimates were not based on monitoring
  data
• Conservative assumptions used in calculations of
  risk
• Precautionary Principle applied

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EU Market Use Directive NP/NPE

• Marketing Use Proposal 2002/0206 (August '02)
• - Directive Proposal for 26th Amendment to
  Council Directive 76/769/EEC
• Marketing and use of NP/NPE should be restricted
  to specific uses however, these specific
  permitted uses are not identified
• Restricted uses are identified and refer to both
  NP and NPE

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EU Market Use Directive Restricted Uses
NP/NPE
(1) Industrial and institutional cleaning
except controlled closed dry cleaning systems
where the washing liquid is recycled or
incinerated cleaning systems with special
treatment where the washing liquid is recycled
or incinerated (2) Domestic cleaning (3) Textiles
and leather processing except processing with
no release into wastewater systems with
special treatment where the process water is
pre- treated to remove the organic fraction
completely prior to biological waste water
treatment (degreasing of sheepskin)
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EU Market Use Directive Restricted Uses
NP/NPE

• (4) Emulsifier in agricultural teat dips
• (5) Metalworking except
• uses in controlled closed systems where the
  washing liquid is recycled or incinerated
• (6) Manufacturing of pulp and paper
• (7) Cosmetics including shampoos
• (8) Other personal care products
• except spermicides

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Amendments to EU Market Use Directive NP/NPE

• Reduce the concentration of NPE allowed in
  products affected by the use restriction from 1
  to 0.1 . The level of NP in products remains at
  0.1.
• Restrict uses of NP/NPE, which result in
  discharges, emissions or losses to the
  environment
• Request that the Commission consider establishing
  a concentration limit value for NP and NPE in
  sewage sludge that is to be spread on land

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Amendments to EU Market Use Directive NP/NPE

• Extend the list of affected uses to 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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Amendments to EU Market Use Directive NP/NPE

• Remove language, which allowed use of NPE when it
  is fully bound in the polymer matrix (finishing
  agents, textile printing, dyestuffs), water.
  Requires processing with no release into
  wastewater
• Classify NP as a priority, hazardous substance
  and direct that the Commission shall submit
  proposals of controls for the cessation or
  phasing-out of discharges, emissions and losses
  of such substances under the Water Framework
  Directive

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Timing of EU Market Use Directive NP/NPE

• Agreement reached between the Parliament, Council
  and Commission (March 2003)
• Legislation will most likely enter into force in
  the Member States by the end of 2004/beginning of
  2005
• Member States are required to adopt and publish
  the laws, regulations and administrative
  provisions necessary to comply with this
  Directive no later than one year after the date
  of its entry into force. They must apply those
  provisions eighteen months after the entry into
  force.

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TNPP

• EU Assessment
• TNPP Added to 4th Priority List
• Rappateur is France
• APERC is lead industry organization

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TNPP

• Current Activities
• Submitted robust summaries to US HPV Program and
  to France
• Responded to questions and issues raised by
  France
• Limited success in gathering downstream
  use/exposure information
• Undertook monitoring program with large customer
  in France which showed low-level release due to
  the very limited solubility of TNPP and its rapid
  hydrolysis, monitoring on NP was conducted

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• Canada

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CEPA Risk Assessment Conclusion

• Section 64(a)
• NP and its ethoxylates from untreated or
  partially treated textile mills that discharge
  directly to the environment occur at levels that
  are likely to be causing harmful effects on
  aquatic organisms
• Discharges from municipal wastewater treatment
  plants and pulp and paper mills contribute NP and
  NPEs to the environment at levels that are of
  concern at a limited number of sites

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CEPA Environmental Objective

• To achieve ambient concentrations in Canadian
  waters that do not exceed Canadian Environmental
  Quality Guidelines 1.0 ug/L NP TEQ for
  freshwater and 0.7 ug/L TEQ for marine water,
  such that no adverse effects are likely to occur
  in the resident aquatic biota

TEQ Toxic Equivalency Quotient, which
considers levels of NP, NPE, NPEC
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CEPA Substance and Sector Risk Management
TME Textile Mill Effluents
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CEPA Proposed Risk Management Goals

• NP/NPE in Wet Textile Processing
• Reduce use by 97 100 by 2009
• Note Dry Textile processes such as nonwovens and
  permanent coating processes are not included
• Pulp Paper
• Voluntary use reduction (Target and Timeline TBD)
• Municipal Wastewater Treatment
• Address NP/NPE at product level

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CEPA Proposed Risk Management Goals

• NP/NPE containing products
• Focus on soap, cleaning detergent products,
  textile and paper processing products
• Reduce use by 50 (2 yr) and 100 (5 yr)
• Proposed baseline year 1998 (or first year after
  1998 when records were kept)

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CEPA Proposed Risk Management Instrument For
Products

• Pollution Prevention (P2) Plans will be required
  by companies that
• Produce or import products specifically for use
  in the soap and cleaning, textile, and pulp and
  paper industries and,
• Exceed an annual threshold of 2000 kg of total
  NPEs used, based on concentrations in products
  and the annual amount of products produced or
  imported
• P2 Plans will be posted on the internet

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CEPA Risk Management Timeline

• NP/NPE declared CEPA toxic (June 2001)
• Started legislative timeline for risk management
• Risk management process in progress
• At least one risk management instrument to be
  recommended by June 2003
• Textiles expected June 2003
• Paper and Products expected Fall 2003
• Risk management instrument to be finalized by
  December 2004

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APERC Position on Proposed Risk Management
Strategy

• Risk management objectives should be based on
  environmental EQGs
• Environmental monitoring should be the primary
  measurement of risk management progress
• Technical feasibility and economic impact of
  reformulation has been underestimated

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APERC Position on Proposed Risk Management
Strategy

• Substitution does not solve problems of poor
  practice and treatment
• NPEs are already managed effectively in most
  situations
• Environmental levels are generally only a problem
  in cases with inadequate treatment
• Without adequate treatment all surfactants pose
  aquatic toxicity risk

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APERC Position on Proposed Risk Management
Strategy

• Pollution prevention plans should be flexible
  rather than prescribing use reduction mandates
• APERC EMP Guidelines can be used in specific high
  volume industries (i.e. TME, Industrial
  Institutional Laundries)

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NP/NPE As A Precedent

• NP/NPE were declared CEPA Toxic primarily
  because they were found in WWT effluent and
  outfalls at levels of concern
• These sites were generally associated with
  primary WWT or secondary WWT plants that were
  overloaded
• Screening of Canadian DSL will likely result in
  additional down-the-drain chemicals to be
  declared CEPA Toxic because they are found in
  WWT effluent

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Suggested Stakeholder Actions

• Provide stakeholder comments when CEPA risk
  management recommendations are published in the
  Gazette
• Wet Textile Processing (June 2003)
• Products that Contain NP/NPE (Fall 2003)
• Paper and Pulp (Fall 2003)

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Canada NPRI

• Addition of CAS RNs for NP, NPE to improve
  reporting accuracy
• Addition of CAS RNs for OP, OPE to track
  substitution trends
• Addition of CAS RNs for NPE derivatives such as
• TNPP
• Phosphate ester derivative of NPE
• Ammonium salt of sulphated nonylphenol
  ethoxylate
• NP-Barium salts

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Canada NPRI

• NP/NPE and NPE Derivatives grouped for threshold
  calculations and reporting purposes (Threshold
  10 tonnes)
• OP/OPE grouped for threshold calculations and
  reporting purposes (Threshold 3 tonnes)

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• United States

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United States

• No regulatory restrictions on use (current or
  pending)
• Broad approval for food contact applications for
  NPE and TNPP under FDA
• NP/NPE were removed from the Washington State PBT
  program in 2002
• Interagency Testing Committee dropped 27 APs from
  Priority Testing List, 3 remain

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United States

• EPA Risk Management Findings (NP)
• No widespread risk to aquatic organisms in US
  waters
• Wastewater treatment facilities are highly
  efficient in removing NP discharge

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United States

• EPA Water Quality Criteria (WQC) for NP
• Uses a statistical analysis of the data
• Initial draft WQC 5.8 µg/L
• Revised draft WQC expected in 2003
• EPA recalculating with more recent data
• Revised WQC expected to be similar
• With proper wastewater treatment and material
  handling, should not be a problem for most
  facilities

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United States

• EPA lead on OECD SIDS program for NPE
• APERC is lead industry contact
• Presented category justification and test plan to
  EPA on November 4, 2002
• Generally well received
• SIDS dossier will be posted on OECD web site for
  comment by other countries

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• APERC Resources

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APERC Resources

• APERC CD
• Narrated overview presentation
• Technical presentations
• Additional technical resources
• APERC Website www.aperc.org
• Toll-free phone number
• (866) APERC - NorthAmerica