reg update52303

Slide1: 

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

Presentation Overview: 

Presentation Overview Antitrust Reminder European Union Canada United States APERC Resources

Slide3: 

European Union

European UnionNP/NPE: 

European Union NP/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

Slide5: 

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

Slide6: 

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)

EU Market & Use Directive Restricted Uses – NP/NPE: 

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

Amendments to EU Market & Use Directive – NP/NPE: 

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

Amendments to EU Market & Use Directive – NP/NPE: 

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

Amendments to EU Market & Use Directive – NP/NPE: 

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

Timing of EU Market & Use Directive – NP/NPE: 

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.

Slide12: 

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

TNPP: 

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

Slide14: 

Canada

CEPA Risk Assessment Conclusion: 

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”

CEPA Environmental Objective: 

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

CEPA Substance and Sector Risk Management: 

TME : Textile Mill Effluents CEPA Substance and Sector Risk Management

CEPA Proposed Risk Management Goals: 

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

CEPA Proposed Risk Management Goals: 

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)

CEPA Proposed Risk Management Instrument For Products: 

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

CEPA Risk Management Timeline: 

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

APERC Position on Proposed Risk Management Strategy: 

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

APERC Position on Proposed Risk Management Strategy: 

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

APERC Position on Proposed Risk Management Strategy: 

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)

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 NP/NPE As A Precedent

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) Suggested Stakeholder Actions

Canada NPRI: 

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

Canada NPRI: 

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)

Slide29: 

United States

United States: 

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

United States: 

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

United States: 

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

United States: 

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

Slide34: 

APERC Resources

APERC Resources: 

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