Title: Nonylphenol and Its Derivatives
1- Nonylphenol and Its Derivatives
- A Regulatory Update
- Barbara Losey
- May 23, 2003
2Presentation Overview
- Antitrust Reminder
- European Union
- Canada
- United States
- APERC Resources
3 4European 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
5EU 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
6EU 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)
7EU 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
8Amendments 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
9Amendments 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
10Amendments 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
11Timing 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.
12TNPP
- EU Assessment
- TNPP Added to 4th Priority List
- Rappateur is France
- APERC is lead industry organization
13TNPP
- 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
14 15CEPA 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
16CEPA 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
17CEPA Substance and Sector Risk Management
TME Textile Mill Effluents
18CEPA 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
19CEPA 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)
20CEPA 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
21CEPA 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
22APERC 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
23APERC 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
24APERC 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)
25NP/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
26Suggested 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)
27Canada 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
28Canada 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)
29 30United 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
31United 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
32United 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
33United 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
34 35APERC Resources
- APERC CD
- Narrated overview presentation
- Technical presentations
- Additional technical resources
- APERC Website www.aperc.org
- Toll-free phone number
- (866) APERC - NorthAmerica