Australian pesticide regulator’s ‘Risk Analysis Framework’ – does it provide transparency to the risk assessment process?

The Australian Pesticides and Veterinary Medicines Authority (APVMA) published a draft Risk Analysis Framework in November 2011 (see http://www.apvma.gov.au/consultation/public/2012/risk_analysis_framework.php). While publication of the Risk Analysis Framework should improve transparency about the way decisions are made within APVMA and should help all stakeholders to understand what data the regulator needs to enable it to make its decisions, lack of clarity within the Framework results in the document failing to clarify what data are required by the regulator.

An example of the lack of clarity in the draft Risk Assessment Framework is the statement that toxicology data are assessed to determine ‘if possible, a “safe” level of exposure in animals.  This is known as the no-observed effect level (NOEL)’.  The Framework also claims that ‘international best practice’ is used for risk assessments.

The Framework, as published leads me to ask if the APVMA really means it uses international best practice or does it really require the use of practices (such as the NOEL) that have been largely abandoned by other regulators?  Without clarity, an applicant cannot decide whether data relied upon by other regulators to approve substances will be be usable by APVMA to assess the risk posed by a substance or not.

The issue of the NOEL is not the only instance of a lack of clarity within the Framework.  But it is an important example.  So what is wrong with the NOEL?

The NOEL theoretically looks at any observed effect.  The NOEL is the dose at which the administered substance causes no effects, irrespective of whether the effects are adverse or not.  Some effects may have no real significance and are not used for regulatory decision-making.  For this reason, the NOAEL or No Observed Adverse Effect Level is now more commonly used for such decision-making.

Consider this example.  Ivan Petrovich Pavlov once did experiments in which he rang a bell when dogs were to get food.  Eventually, the dogs would start to drool whenever the bell was struck (because they associated the bell with food).  We know drooling, or salivation, is an important response to food.  It starts the digestive process.  However, it would not normally be considered an adverse effect — but it is an effect.

Assume if, instead of striking a bell, Pavlov sprayed some chemical into the air.  The animals might start drooling every time they smelt the chemical, expecting food to be served.  Would we consider drooling in this case to be the type of effect that should drive regulatory decision making, i.e. determine if the chemical is allowed to be sold or not?  Should we say a chemical is not allowed to be sold or used because it causes drooling in this experiment?

If the regulator requires the dose or concentration at which No Effects are observed to be used for regulatory decision making,  the drooling would have to be considered an effect and would need to be used as the basis for decisions such as whether a chemical can be supplied or not.  In this case, to select a  “safe” level for the chemical, as defined by the regulator, we would need to look for a concentration of the chemical that does not cause drooling.  The highest rate or concentration of the chemical tested that does not induce drooling would be termed the NOEL.

In contrast, the NOAEL would recognise drooling is an effect but not an effect that is significant in relation to regulatory decision-making.  Decisions about whether to permit supply or use of the chemical would need  to be made on adverse effects.

What effects are “adverse” is something that competent toxicologists must determine.  The NOAEL is the highest dose tested that did not produce any toxicologically significant effects, as determined by the expert toxicologists.  APVMA has access to highly competent toxicologists (and other experts).  However, the Framework, as written, could reduce the ability of these experts to use their expertise in regulatory decision making.

Some people may argue no competent regulator would make a decision simply because, say, an animal started to drool because of some odour.  This may be true but we know regulators are not always the final decision makers, e.g. legal action may result in courts requiring a strict interpretation of terms used in the Framework.

To avoid problems in the future, I believe it is essential that the Framework use  precise terminology.

On the other hand, if APVMA really does not want experts to have the flexibility to use their expertise in decision making, and does require them to use the NOEL rather than the NOAEL or other appropriate criteria, then APVMA should not mislead stakeholders by claiming it uses ‘international best practice’.

In my view, the Risk Analysis Framework must be amended to ensure there is clarity as to what is expected.  Only then will the regulated community, the regulator and other stakeholders have common ground for determining what is and what is not acceptable.

 

Acceptability of Chemicals for Use in Food Establishments

 

AQIS stopped issuing ‘Instruments of Approval’ (IOAs) and ‘Letters of Acceptance’ (LOAs) on 1 July 2011 (see AQIS Meat Notice Number 2011/05: http://bit.ly/nRu9tI).  Existing IOAs and LOAs will remain effective until they expire.  A system of self-declarations issued by the manufacturers/suppliers of chemicals has been proposed by AQIS to replace the IOAs and LOAs.

 

What does this mean to operators of food establishments and to food auditors?

The IOAs and LOAs were issued by AQIS to confirm acceptability of specified chemicals for use in export meat establishments.  These documents were relied upon by those approving use of chemicals in a broad range of food establishments to indicate suitability for use in all food establishments.

As the IOAs and LOAs expire there will no longer be any certification of suitability for use in food establishments issued by an official (government) organisation.

AQIS has proposed that suppliers of chemicals provide ‘declarations’ (i.e. self-declarations) for suitability of use in export meat establishments.  The self-declaration must indicate the chemical substance is fit for use in export meat establishments.

According to the AQIS Meat Notice, occupiers of export meat establishments are now responsible for ensuring compliance with Australia’s export legislation.

The responsibility for determining suitability of chemicals for use in food establishments is now transferred to operators of food establishments and food auditors.

 

What constitutes suitability or fitness for use in a food establishment?

There are many aspects of chemicals that influence fitness for use in food establishments.  These include:

  • Approval for use in the foods, i.e. the ingredients are listed in the Food Standards Code for use in the relevant foods.
  • Where chemicals are not listed in the Food Standards Code, use does not leave residues that contaminate food.
  • The ability of the chemical to taint food.
  • The ability of the chemical to alter the colour of food.
  • Compatibility of the chemical with operations in the area in which they are used.
  • Performance of the chemical, e.g. a disinfectant provides the required level of control/reduction of contaminating microorganisms.

Determining if a chemical is fit for use in a specification situation requires the person approving the use of the chemical to know the identity of all substances in a chemical product and to understand each ingredient’s approval status.  Understandably the need for manufacturers to disclose all ingredients in a formulated product to third parties presents concerns over the proprietary control of formulations and the intellectual property that is the basis for the formulations.

To overcome this concern, AQIS has proposed that chemical manufacturers/suppliers provide self-declarations confirming suitability for use in export registered meat and meat product establishments.

 

What is the impact of self-declaration?

Those making self-declarations and those relying on self-declarations may misinterpret the essential requirements for safety and fitness for use:

  • The Declaration refers to ‘Hazardous Substances’.  It also refers to the MSDS (Material Safety Data Sheet) or SDS (Safety Data Sheet).  The definition on an MSDS/SDS for ‘hazardous’ is different to that used by AQIS.  The MSDS/SDS uses the Work Safe Australia criteria to determine whether a chemical is hazardous or not.  In contrast, AQIS uses the term to substances ‘hazardous’ to the food.  It is possible for a material classified as non-hazardous according to Work Safe Australia to be hazardous to food. We recommend the proposed declaration replace the term ‘hazardous’ with ‘chemical’, i.e. the title should be ‘Declaration for a Chemical Substance for Use in Export Registered Meat and Meat Product Establishments’.
  • AQIS recommends that an MSDS/SDS be provided with the Declaration.  We believe this could be misleading as the MSDS/SDS is designed to disclose hazards to workers and the environment.  Typically, an MSDS/SDS only lists hazardous constituents.  Without full formulation details it is not possible to determine if a formulated product is suitable for use in a food establishments, e.g. fragrances would no normally be disclosed on an MSDS/SDS but are generally unacceptable for use in export meat establishments. We recommend that the MSDS/SDS be used for the purpose it was designed for and not for determining suitability for use in specific food establishments.
  • The person issuing a declaration may not have full knowledge of all situations in which products are to be used and which declarations are to be issued. There will be a need for those approving use of specific chemicals in food establishments to determine whether the declaration can be trusted or not.

 

How can the industry benefit from the changes made by AQIS?

Full benefit of AQIS no longer issuing Instruments of Approval (IOAs) and Letters of Acceptance (LOAs) can be achieved if:

  • Those issuing self-declarations and those relying on self-declarations accept the replacement of the term ‘hazardous’ with ‘chemical’, i.e. the title should be ‘Declaration for a Chemical Substance for Use in Export Registered Meat and Meat Product Establishments’.
  • Those approving use of specific chemicals in food establishments, including auditors:
    • Only use MSDS/SDSs for the purpose for which they were designed for and not for determining suitability for use in specific food establishments.
    • Determine whether the declaration can be trusted or not.
    • Consider aspects of chemicals that might adversely affect the wholesomeness of foods.  They should not hesitate to contact the supplier to gain confirmation that, in issuing a declaration, the supplier has addressed all aspects.
  • Persons approving use of chemicals in food establishment:
    • Consider the supplier’s reputation.  Is the supplier known and trusted?  If the supplier is not well known to the person approving use of chemicals, determine what actions are possible if a chemical substance is found to be not suitable for use in situations specified in a declaration.
    • If a chemical is applied by a contractor (e.g. a pest control operator), ensure the contractor provides full details of the use of the chemical substance, e.g. a pest control operator should state precisely how much pesticide was mixed, how much was applied, the rate applied, and where it was applied.  The information should be left at the premises.  It will be invaluable if a problem arises and the supplier and contractor disagree as to who is responsible – note the Declaration states it is only valid if the product is used correctly.
  • Exchanging information using this blog – leave comments to enable discussion about aspects of concern.

What have we learned in the last 100 years about poisons?

Over the last 100 years our knowledge of “poisons” has increased dramatically.  We can look back now at some of the products used in the early 20th Century and we ask how could anybody have been so stupid.  What have we learned from these early experiences?

I recently read “The Poisoners Handbook” by Deborah Blum (Penguin Books).  The book describes use of poisons for murder in the early 20th Century in the US but also gives an excellent insight into some of the issues of the time.  Reading the book made me think about the implications for pesticides today.

Here are some interesting facts from Blum’s book:

  1. Prohibition increased the number of people affected by methanol poisoning.  Unlike ethanol (“drinking alcohol” or food grade alcohol), methanol is toxic — it is converted to toxins in the body e.g. formaldehyde.  People selling alcohol illegally in the US during Prohibition often substituted cheaper methanol for food quality alcohols.
  2. In the mid-19th Century people would drink mercury believing it would cure constipation.
  3. Mercuric chloride was sold as a pesticide (to control bedbugs) as well as being an ingredient in laxatives, antiseptics and diuretics.  Doctors prescribed mercuric chloride for chronic bacterial infections.  The substance is corrosive to eyes, skin and the digestive tract and today, the IPCS Inchem datasheet for mercuric chloride states “Avoid all contact!”
  4. Tetraethyl lead was found to cure knocking in car engines.  Workers in the Standard Oil plant making the substance were observed to have become “a little odd”.  They would become lost in plant grounds.  They had troubling remembering friends and eventually, they started collapsing, convulsing and “babbling deliriously”.  Standard Oil’s response was “these men probably went insane because they worked too hard”.  Apparently, the company “didn’t see a problem” other than for the workers working themselves to death.
  5. Radium was used in consumer products including radium water (to make the “drinker sparkle with energy”), radium soda, radium candy, radium based facial creams (to rejuvenate the skin), radium facial powders as well as soaps and pain-relieving preparations.  Marie Curie used to carry a phial of radium in her pocket – she liked to watch the “pretty blue-green light” in the dark.  Marie Curie died from effects attributable to radium.

Some questions that arise from the above:

  1. Prohibition was a failure.  It did more harm than good.  Is the current regulation of pesticides doing more harm than good?
  2. In the 19th Century people did not know the dangers associated with mercury.  That did not stop them from dying from the effects of consuming mercury.  What is it that we do not know about the products we use today?
  3. People, even qualified medical practitioners, were recommending the use of a highly corrosive substance, mercuric chloride.  It was used in cosmetics yet it was known to be corrosive.  Can we blame these people for using what was available at the time, e.g. to cure syphilis?  Today we have safer and more effective products but what were the options then?
  4. People working themselves to death?!?  We can claim Management at Standard Oil was irresponsible but do we not still see similar excuses being made by companies?  Look at tobacco, asbestos.  What do we not know about some of the other products on the market?
  5. Marie Curie believed in her invention.  People did not understand the dangers.  Yet they died as a result of the inherent “qualities” of radium.  What do we need to know to prevent the next big invention killing us?

Regulation is important, but it should not build such high barriers to entry that people find ways around the barriers.  As with prohibition, the alternatives found may pose unacceptable risks.

We also need to be aware that new technologies, such as radium, might come with new risks.  However, we cannot refuse to adopt these new technologies while waiting for safety to be demonstrated – nothing is safe; even water poses unacceptable risks in certain situations.  If alternatives to mercuric chloride were not allowed onto the market, would we still be relying on mercuric chloride to treat chronic bacterial infections?  In the same way, failing to allow new crop protection technologies can force us to continue relying on old technologies.

While we do require regulatory systems that facilitate entry of new technologies, we cannot forget that people may, maliciously or through ignorance, ignore risks posed by these technologies.  It is essential to have an effective regulatory system that minimises the potential for commercial interests to adversely impact the health of people and the environment in general.  But, the system must not build such barriers that those commercial interests find other ways to expose us to their products.  Prohibition failed.  We can learn from that experiment.