VEGA comments on a DEFRA consultation on the enforcement of REACH in the UK.
VEGA comments on a DEFRA consultation on the Enforcement of REACH in the UK. REACH came into force on the 1 June 2007 in the UK.
1. This is an OverReach document: it requires much more assessment of intentions on the basis of definitions and tapped experiences from physiologists and regulators of the pharmaceutical industry and of the Home Office. In other words, it needs a scientific foundation before the battleship plant of legislation and enforcement come to a grounding in waters inadequately fathomed but still capable of the passage of more maneuverable vessels flagged with good intentions.
2. Medical and veterinary advice must be sought urgently and draft of proposed working examples should be put about to focus the challenges in the light of increasing knowledge in physiology, genetics, immunology, and the pharmacology of toxophores that could reduce the toll of suffering caused by experimentation on non-human animals, even when Home Office stipulations are applied.
3. Collation of all existing and succeeding results of relevant biological information must be openly accessible. Proposed alternatives should be considered and assessed against existing dossiers of relevant knowledge in the manner of, say, the NICE system of controlling applications in medical practices and on adverse reactions reported by doctors and vets (REACH principles should embrace all animals, wildlife, and the environment and therefore take account of compounds designed and tested for selective toxicity – or be “natural” chemicals with such properties).
4. Such provisions require collection of information for screening and epidemiological purposes of workers in factories producing nominated chemicals and handlers of such compounds. Enlistment in longterm studies such as BioBank should be required.
5. Interactions (“cocktail effects”) and usage must temper interpretations of “safety” and generate warnings emphasizing the need for experience, education, and common sense on chemicals “generally regarded as safe” (i.e. in the GRAS category for food additives) and justifying a “not tested on animals” approbation. Allergenicity is just one susceptibility to test the ordinary citizen’s confidence in REACH Authorizations.
6. “Chemicals” is a word requiring much consideration of “everyday” concepts and common usage against scientific and legal definitions.
6.1 Many chemicals are sold in forms that could complicate testing and authorization. “Petrol” is sold in different grades, with varying constituents, and with a range of products of combustion released into the atmosphere.
6.2 Speciation is another complication. Thus “arsenic” may arise in inorganic and organic forms, as a gas or solid, some highly dangerous, others apparently innocuous and occurring in foods esteemed for their beneficial properties for consumers (eg sea foods). Similar reservations obtain in assessments of “mercury”.
6.3 Assessments of “endocrine disrupters” and phytosterols and phytoestrogens in the environment and foods need qualification in terms of physiological principles of antagonists and agonists, as well as accumulations of biochemical and even anecdotal evidence on receptors and genetics that make the line between harm and benefit tricky to define; and it may be blurred by the age and circumstances of the consumer, user, or contact.
6.4 Some substances used as ointments and as components of food and in other contacts (eg in medication) may be “safe” and beneficial in some applications but damaging if the user is exposed to sunshine (because of the effects of ultraviolet radiation). Onions are safe to handle in the kitchen and on the farm or allotment but cutting the bulbs can elicit adverse reactions and inflammation in users who may be immune to the pollen acting in an allergic way from the crops commonly grown in farming or as “natural” and esteemed components of our environment.
6.5 Disinfectants, antiseptics, and detergents, as well as alcohol, may function as desirable “safe” inhibitors of bacterial and viral infection, but this effect may be too drastic and unspecific in the interests of hygiene when survival of benign and beneficial micro-organisms becomes suppressed and development of multi-resistant populations and dehydration of the skin supervene.
6.6 Consultations at this stage must avoid loading heavy legal and policing apparatus on inadequate scientific and educational preparation to matters that could be considered to the common good more constructively than the present consultation offers.