Submission on the Proposed Group Standard for Tattoo Inks and Permanent Make-up Substances

Transcription

1 Auckland Regional Public Health Service Cornwall Complex Floor 2, Building 15 Greenlane Clinical Centre Private Bag Symonds Street Auckland 1150 New Zealand Telephone: Facsimile: th July 2011 Rachel Kleinsman Environmental Protection Authority P.O. Box 131 Wellington Submission on the Proposed Group Standard for Tattoo Inks and Permanent Make-up Substances 1. Thank you for the opportunity for the Auckland Regional Public Health Service (ARPHS) to provide a submission to the proposed group standard for tattoo inks and permanent make-up substances. 2. The following submission represents the views of the Auckland Regional Public Health Service and does not necessarily reflect the views of the three District Health Boards it serves. Please refer to Appendix 1 for more information on ARPHS. 3. ARPHS understands that all submissions will be available under the Official Information Act 1982, except if grounds set out under the Act apply. 4. The primary contact point for this submission is: Andy Roche Policy Analyst Health Improvement & Business Support Auckland Regional Public Health Service Private Bag Symonds Street Auckland ext aroche@adhb.govt.nz Page 1 of 9

2 EXECUTIVE SUMMARY 5. Thank you for the opportunity to comment on the proposed group standard for tattoo inks and permanent make-up substances. ARPHS supports the implementation of the proposed group standard as a way of controlling the human health risks from tattoo inks and permanent make-up substances. 6. ARPHS believes that the move from a negative list to a positive one should be made as soon as possible, given the likely toxicity of some of the ingredients of many products. 7. ARPHS believes that the proposed group standard can be improved and refined in a number of areas to remove ambiguity and improve clarity. 8. ARPHS believes that further thought needs to be given to how the role of the Medical Officer of Health in the group standard is to be undertaken. ARPHS suggests that the pre-existing group standard for graphic materials provides a suitable implementation model to base the proposed tattoo inks and permanent make-up substances group standard on. TATTOO INKS, PERMANENT MAKE-UP SUBSTANCES AND PUBLIC HEALTH 9. ARPHS has two separate interests in the proposed group standard for tattoo inks and permanent make-up substances (the proposed group standard), as follows: As a public health unit ARPHS recognises the potential for substances injected into the skin to cause harm and wishes to see that potential harm minimised. The Ports of Auckland and Auckland International Airport are the facilities through which a substantial proportion of the goods imported into New Zealand arrive. The proposed group standard requires the notification of import or manufacture to the Medical Officer of Health and it is likely that ARPHS will have a central role in ensuring compliance with the proposed group standard, just as it does with the graphic materials group standard. 10. ARPHS comments are structured in two parts, general comments on the assessment document and more detailed comments on the proposed group standard. COMMENTS ON THE PROPOSED GROUP STANDARD ASSESSMENT DOCUMENT 11. ARPHS supports the Environmental Protection Agency s (EPA s) conclusion that tattooing products have historically been poorly regulated compared to other products that do not involve invasive application. 12. ARPHS notes EPA s research as to the nature of tattoo inks and permanent make-up substances and is concerned that some of those products involve the use of heavy metals and other substances that are toxic to humans. ARPHS also appreciates that there are potentially thousands of products available to New Zealand users. It will prove challenging from the regulatory perspective to manage these risks and provide confidence that the regulatory regime adequately protects New Zealanders. Page 2 of 9

3 13. Page 20 of the Assessment Document states that Pigments used in tattoo inks are based mainly on industrial organic pigments and heavy metals. Such products bring with them a range of health risks. The health risk associated with such chemicals is such that great care is needed in their use. Traditional metallic salts are prevalent in tattoo inks, including lead, mercury, cadmium, nickel, zinc etc. A 3x5 inch tattoo may contain from 1 to 23 micrograms of lead; 1 lead exposure in sufficient quantities has been linked to neurological and kidney damage, miscarriage, gastrointestinal symptoms etc. 2 Organic pigments (i.e. non-heavy metal pigments) may also pose health concerns. The European Commission noted that close to 40% of organic tattoo colorants used in Europe had not been approved for cosmetic use, and that under 20% of colorants contained a carcinogenic aromatic amine There is no information given (except in Schedule 5, which deals with them as impurities) about the acceptable concentration of these chemicals in approved products. Nor is there any information on the levels that may give rise to toxigenic effects in humans or the significance of skin injection as a portal of entry. When such products and chemicals are invasively used there will be a number of variables that should be considered. A blanket acceptance of products without specific scientific justification as to their safety creates a regulatory risk and risk to human health. 15. Page 21 of the Assessment Document makes specific comment that the safety of glow in the dark and other fluorescent dyes have not been assessed. All products approved as tattoo inks or permanent make-up substances should have their safety assessed prior to inclusion in any approved list. The only possible exception may be products originally manufactured for medical use as these most likely will have been approved under other regulatory regimes. As a general principle it is unacceptable in public health terms to agree to the use of a product until it can be demonstrated to be safe and not have long term consequences for human health. The EPA will need to define the parameters very clearly that will enable medical officers of health to agree release of controllable products for use on humans. 16. ARPHS notes the comment on page 23 of the Assessment Document that two practitioners believe that mineral based pigments used in permanent make-up substances have no health implications. This statement appears to be the Assessment Document s sole consideration of the issue of safety of permanent make-up substances. It is disappointing that the Assessment Document contains no scientific assessment of the accuracy of this belief. 17. The proposed regulatory regime for tattoo inks and permanent make-up substances can be compared with the current regulatory regime for controllable graphic materials. The graphic materials regime is based around strict control of a suite of eight heavy metals all of which are listed in the Assessment Document as known ingredients of tattoo inks (or impurities known to be in tattoo inks). 18. Recognising the regulatory regime applicable in other jurisdictions with control standards comparable to New Zealand may be a practical way of quickly improving the New Zealand regulatory regime. 1 Metal Toxicity: Tattoos: Safe Symbols?, Environmental Health Perspectives, retrieved 19 October The Environmental Case Management of Lead-exposed Persons, Ministry of Health, Workshop on "Technical/scientific and regulatory issues on the safety of tattoos, body piercing and of regulated practices", European Commission, Page 3 of 9

4 19. ARPHS believes it would be essential for the regulatory regime to require independent assurance of the quality and safety of tattoo inks and permanent makeup substances (traceable to individual production batches) and for evidence of such assurance to be required to be supplied to both regulators and end users. 20. The reality of global manufacturing means that independent assurance of the quality and safety of tattoo inks and permanent make-up substances, is best assured by the use of independent quality assurance and testing organisations, holding appropriate accreditation, in the country of origin. This is to the advantage of a manufacturer who can then use the ready availability of reputable test results as a marketing tool. 21. Allowing manufacturers to print a statement on packaging to the effect that an item complies with a recognised European standard does not provide the same level of assurance for control purposes as certification from an independent accredited laboratory. Such a statement is not acceptable for graphic materials clearance purposes. 22. It is a commercial reality that some manufacturers will reduce quality as a way of attempting to respond to competition. A reduction in quality or substitution of ingredients with cheaper ones presents a risk to those having the substances injected into their bodies. This is why a mechanism is essential to verify on-going same formulation since verification testing. This would align with the controllable graphic materials import regime. 23. ARPHS reluctantly agrees that adopting the European Union standards is the most practical approach at this time. ARPHS believes that the proposed group standard should only be viewed as the first step. ARPHS hopes that the proposed group standard is sufficiently flexible to allow the move from a negative list to a positive list to happen as quickly as possible. SPECIFIC COMMENTS ON THE PROPOSED TATTOO INKS AND PERMANENT MAKE- UP SUBSTANCES GROUP STANDARD Scope of Group Standard 24. Manufacturing is likely to cover business sizes ranging from multinational companies to small backyard operations. There will be a wide variety of standards, controls, ingredient quality and scientific knowledge of both components and their potential adverse human consequences. The control process proposed may be reasonably effective when used by visible manufacturers and importers, but may be far less appropriate for smaller backyard type businesses. The invasive nature of tattooing means that the group standard needs to effectively regulate smaller ink and permanent make-up substance manufacturers and importers. 25. The New Zealand consumer has a reasonable expectation that products purchased in NZ for individual use and products used for NZ commercial purposes are all fit for purpose. If this group standard does not turn out to be as robust in practice as is intended in theory, a false sense of security will be generated - giving consumers a lower index of suspicion. This is a particular concern due to the invasive nature of tattooing. Page 4 of 9

5 26. It is unclear as to whether the term manufactured (clause 4(1)) includes the creation of tattoo inks in New Zealand for self application and / or traditional tattoo inks manufactured from ingredients otherwise legally available in New Zealand. ARPHS does not share the EPA s belief that traditional tattooists only use commercially available inks. The Ministry of Health s guidance for traditional tattooists clearly envisions that some traditional tattooists may make their own ink. 4 ARPHS experience is that while some traditional tattooists are experimenting with commercially available inks, many still manufacture their own inks. ARPHS believes that the definition of manufactured should specifically capture inks prepared for self application and also traditional tattoo inks. Conditions of Group Standard 27. ARPHS supports importers and manufacturers being required to demonstrate that substances comply with the proposed group standard. In ARPHS experience with graphic materials, importers (and some customs agents) frequently have a low level of understanding of the regulatory clearance process. Overseas manufacturers are best placed to provide authenticated paperwork to clients. Schedule 1 Conditions of Group Standard Part 1 Information Requirements 28. The proposed information sheet could usefully suggest directing any enquiries to the EPA for triage to other agencies as appropriate. 29. Although the intention of clause 1(1) may be to prevent information being supplied in languages other than English and aid compliance; the wording as currently drafted does have the effect of excluding New Zealand s two other official languages (Maori and NZ Sign) from being used. 30. It is unclear from the proposed group standard how compliance with the general information requirements and specific labelling requirements is to be determined. Similarly, is an importer expected to demonstrate the existence of safety data sheets? 31. As noted previously there is a substantial difference between claiming that a product is safe and independent assurance by a third party accreditation agency that a product meets legislative requirements. 32. The group assessment document refers to tattoo inks and permanent make-up substances either being sterile or non-sterile. ARPHS believes that for these products the following information is necessary: Sterile products information on storage requirements and shelf life (particularly once opened). Non-sterile products information on shelf life and on sterilisation requirements and techniques that must be undertaken before the product is used. 4 Ministry of Health Customary Tattooing Guidelines for Operators. Wellington: Ministry of Health accessible through Page 5 of 9

6 Part 9 Notification to Medical Officer of Health 33. As noted previously ARPHS is very concerned at the requirements for notification to the Medical Officer of Health which state: Any person importing or manufacturing a tattoo or permanent makeup substance must first provide evidence to the Medical Officer of Health that it meets the minimum requirements of Clause 4 of this Group Standard. 34. It is unclear from the proposed group standard what action the Medical Officer of Health is expected to take once s/he receives evidence that a product meets (or doesn t meet) the minimum requirements of Clause 4 of the group standard. 35. The wording implies that the Medical Officer of Health is expected to give approval before a product is imported and / or manufactured. The proposed group standard contains no guidance on the standard of evidence that is deemed to be adequate. There is a world of difference between the level of evidence required if a Medical Officer of Health adopts a precautionary approach in reviewing such evidence than, say, evidence based on the balance of probabilities. 36. There is no information or guidance as to how such evidence is to be kept up to date, given the likelihood that manufacturers will constantly search for new ingredients and formulae to ensure that their product has a competitive advantage. Is an importer or manufacturer expected to provide evidence for every importation (even if two separate importations comprise products made in the same batch) or for every ingredient change? 37. There is no evidence from the Assessment Document that there has been any analysis undertaken to demonstrate that public health units have the capacity to undertake this new work, nor is there any indication as to how this work will be funded. 38. Medical officers of health are designated officers for the region(s) in which they are appointed. Incoming consignments of tattoo inks and permanent make-up substances will be subject to the jurisdiction of the Medical Officer of Health for the location of the importer. The group standard is silent on how (or if) the Medical Officer of Health is to be alerted about an incoming consignment. There is no indication as to how national consistency is to be achieved between differing medical officers of health or public health units. 39. Under historic funding arrangements negotiated with the Ministry of Health, ARPHS has a national role in the control of imported, controllable graphic materials. This role reflects the geographical reality that most products are imported through Auckland. 40. ARPHS suggests that the pre-existing approach used to control graphic materials provides an appropriate model that could be extended to tattoo inks and permanent make-up substances. 41. It may also be more appropriate for the work to be taken on a user pays basis, so that the importer or manufacturer directly funds the required work, rather than imposing a general charge on tax payer funds. Page 6 of 9

7 42. The group standard is also unclear as to which agency is responsible for follow up enforcement should a product that does not comply with the group standard be imported or manufactured in New Zealand. Perhaps this will depend upon the exact nature of any breach? The proposed group standard is also silent on whether there is any cost recovery mechanism for such follow up. 43. ARPHS notes the Assessment Document s reference to the risk of tattoo inks and permanent make-up substances being purchased from third world countries via mail order and internet transactions. Such importations are likely to be a combination of commercial importation and individuals importing products for self application. 44. The proposed group standard is contains no information as to what control processes are to be applied to incoming postal or courier packages. All products entering the country have some form of Customs control. What mechanism will be incorporated into the current controls to ensure that tattoo inks and permanent make-up substances are flagged by Customs on importation so that they can be referred to the appropriate agency? 45. ARPHS has had previous experience of traditional medicines (not formally controlled) that contained unsafe levels of lead - which were imported by individuals. The resulting health consequences required treatment. Any group standard that does not address all the ways in which a controlled product might enter the country is flawed. Part 10 Other Matters 46. It is unclear as to how long the record referred to in clause 22(1) must be kept available for inspection. It is also unclear as to which entities are to be viewed as independent for the purposes of clause 22(2). Schedule 4 Components Tattoo and Permanent Make-up Substances Must Not Contain 47. As stated in the Assessment Document Collectively the number of potentially toxic substances in the colour pigments is high. ARPHS considers that the approach of prescribing what cannot be included in tattoo inks and permanent make-up substances is a weakness. Under this approach, by definition, practically anything else is potentially a legal ingredient, no matter what its relative toxicity. An approach that prescribes what can be included is a far safer option. 48. ARPHS believes that the proposed negative list approach of using pre-existing overseas standards to define what products are safe will allow for speedy implementation of the group standard, but it is less than ideal. 49. There is comment in clause of the Assessment Document to the effect that a positive list is desirable, but there is no mechanism set out as to how such a positive list will be developed. ARPHS hopes that the creation of a positive list will form part of the EPA s future work programme, and that the proposed group standard has sufficient flexibility to support a rapid change from a negative list to a positive one. Explanatory Note 50. The Explanatory Note suggests that a variety of mechanisms may be acceptable for determining whether or not there is compliance with the group standard. ARPHS suggests that any such mechanism needs to be simple, consistent, robust and transparent. Page 7 of 9

8 CONCLUSION 51. Thank you for the opportunity to comment on the proposed group standard for tattoo inks and permanent make-up substances. ARPHS supports the implementation of the proposed group standard as a way of controlling the risks from tattoo inks and permanent make-up substances. 52. ARPHS believes that the proposed group standard can be improved and refined in a number of areas. It believes that the move from a negative list to a positive one should be made as soon as possible, given the likely toxicity of some of the ingredients of many products. 53. ARPHS believes that further thought needs to be given as to how the role of the Medical Officer of Health in the group standard is to be undertaken and funded. ARPHS suggests that the pre-existing group standard for graphic materials provides a suitable model for use with the proposed group standard for tattoo inks and permanent make-up substances. Yours sincerely Frank Booth Service Manager Auckland Regional Public Health Service Dr Denise Barnfather Medical Officer of Health Auckland Regional Public Health Service Page 8 of 9

9 Appendix 1 - Auckland Regional Public Health Service Auckland Regional Public Health Service (ARPHS) provides public health services for the three district health boards (DHBs) in the Auckland region (Auckland, Counties Manukau and Waitemata District Health Boards), with the primary governance mechanism for the Service resting with Auckland District Health Board. ARPHS has a statutory obligation under the New Zealand Public Health and Disability Act 2000 to improve, promote and protect the health of people and communities in the Auckland region. The Medical Officer of Health has an enforcement and regulatory role under the Health Act 1956 and other legislative designations to protect the health of the community. ARPHS primary role is to improve population health. It actively seeks to influence any initiatives or proposals that may affect population health in the Auckland region to maximise their positive impact and minimise possible negative effects on population health. The Auckland region faces a number of public health challenges through changing demographics, increasingly diverse communities, increasing incidence of lifestylerelated health conditions such as obesity and type 2 diabetes, outstanding infrastructure needs, the balancing of transport needs, and the reconciliation of urban design and urban intensification issues. Page 9 of 9