Summary of submissions on NZFSA public discussion paper 09/09 Implementation of the ACVM Act: changes to the ACVM Regulations 2001

Summary of submissions by issue

NZFSA response

Notes that animal feeds (or oral nutritional compounds) make up only a small proportion of the products which may be considered under the ACVM Regulations. Notes that the manufacture of compound feed does not conform to the same parameters as found in the manufacture of other products. Expresses concern on this basis that the proposed amendments will force unnecessary and costly compliance measures on the manufacture of animal feed with little benefit for the livestock producer or consumer, but at significant cost.

This concern appears based on a perceived discrepancy in the manufacturing parameters between those for feed manufacture and those for other products under the ACVM Regulations. NZFSA considers that there is no discrepancy between the parameters. There must be a person responsible and there must be a plan to manage risks down to an acceptable level. NZFSA agrees that what specifically needs to be addressed varies greatly between kinds of products. NZFSA agrees that there are challenges and solutions that are unique to the feed manufacturing industry. NZFSA’s expectation is that each industry sector will address manufacturing in a way that is most appropriate for that industry to manage the risks listed in the ACVM Act as they relate to that industry. NZFSA will not impose an obviously inappropriate manufacturing regime on an industry sector, and has no intention of taking a ‘one size fits all industries’ approach. The ACVM Act is administered on the basis of an expectation that every manufacturer of agricultural compounds will manufacture in a way that is consistent with good practice, supported by a quality system. The proposed changes will not alter this expectation, and on this basis they will have little impact on responsible manufacturers.

Is concerned that the discussion document seems to suggest that greater regulatory requirements may be placed on products which may be useful in the control of, for example, Salmonella in animal populations. Does not believe that such an approach would benefit the public as it is likely that the use of antibiotic alternatives or other feed additives would subsequently be reduced and consequently any potential control of undesirable microbial populations would be lost.

NZFSA notes the submitter’s concern about potential increased regulatory intervention, but is not clear how this concern relates to the proposals. There is nothing in the proposals that would signal a change to the imposition of formal audit programmes or other, more onerous regulatory requirements. It should be noted that manufacturers’ operating plans do not have to be approved by NZFSA. Manufacturers are, in the first instance, their own judge of due care.

Suggests that managing risks to public health under the ACVM Act should include identifying and managing risks that are outside the scope of the Biosecurity Act 1993, and that the Biosecurity Act can deal with any risks relating to public health/animal health and welfare.

The scheme of the ACVM Act includes an express obligation to avoid controls that would be redundant given controls under other legislation. Therefore, although the risks being managed under for example the Biosecurity (Ruminant Protein) Regulations 1999 are in the scope of the ACVM Act, NZFSA would not intervene with current regulatory arrangements that are working adequately.

Expresses concern that the proposed public health ‘fit for purpose’ requirements are extensive and could easily be misinterpreted. Suggests it is unclear what would happen if a product was found to breach these requirements.

Notes that the information available on products can change, and consequently the use of products can become less acceptable. Asks if a product deemed acceptable in the present environment were to become less acceptable in future, what are the implications for industry/registrant/user?

NZFSA is obliged to take public health into consideration for agricultural compounds; this proposal gives effect to a change in section 4 of the ACVM Act. The proposed requirement for feed manufacturers is basic. It would involve considering the likelihood of their products spreading human pathogens, and taking steps to manage the risk to an acceptable level. The risk is not significant now, so current practices appear to be sufficient. While there is always a possibility of misinterpretation, industry and NZFSA guidance is expected to be sufficient to ensure that unnecessarily-rigorous control systems are avoided. It should be noted in this regard that the offence in the ACVM Act is to knowingly breach the conditions of exemption; it is not strict liability. This means that any party who in good faith took due care based on the information available at the time (which may later be found to be insufficient to manage the risk) would be managing their statutory obligations.

NZFSA agrees that the future status of products is subject to change. The ACVM Act requires risks to be assessed, and risk factors can change. This could be because of new information as suggested. NZFSA routinely updates the ACVM Regulations in response to change, and communicates the changes to industry, registrants, and users.

Notes animal feeds do not have a ‘master formulation’; the ingredient profile of all animal feeds is likely to change regularly in response to changes in availability and price of raw materials. Despite this, the productivity of animals fed these diets and the suitability of their products for human consumption does not change.

There is nothing in the manufacturing requirements that prevents a master formulation from specifying variability in ingredients. NZFSA considers the phrase ‘manufactured consistently’ means ‘manufactured in accordance with the manufacturer’s operating plan’ (i.e. manufacturing quality system). NZFSA did not intend it to be taken as meaning ‘manufactured with exactly the same ingredients’. If ingredients vary, a product’s master formulation should vary the formulation in a predictable manner with ‘fit for purpose’ rules governing selection and inclusion of the ingredients. As it is NZFSA’s experience that responsible feed manufacturers’ master formulations do exactly that, the proposed requirements do not hinder established practices.

Suggests labelling requirements for imported products are unclear – is the importer’s name and address sufficient?

Imported product is under the same obligations as product manufactured in New Zealand. There must always be some party in New Zealand who is responsible for complying with those obligations. In each case of non-compliance (relating to imported or domestic product) that NZFSA has investigated, a party was found to be responsible and action taken accordingly. Labelling the product with the name and address of the importer is only sufficient if the importer is actually the party responsible for the product.

Notes the vast majority of animal feed is made up of grains, protein meals, vitamins and minerals which would not usually be considered “active ingredients”. Notes there has been considerable discussion with NZFSA on this issue. Requests that NZFSA include clarification that for animal feeds a statement such as “Ingredients selected from…” be considered acceptable for animal feeds. As such, does not believe any change to the labelling regulations for animal feeds would be necessary.

NZFSA approved the current code of practice that includes guidelines for stating ingredients for animal feed. NZFSA continues to support the status quo as long as the industry as a whole still considers its guidance sufficient. NZFSA does not consider the ACVM Regulations need to specify any new or additional labelling requirements for animal feed, given the existing guidance on ingredient labelling sets out that information.

Comments that it is impossible to prevent some contamination in an animal feed mill, and that there are instances when some cross contamination or deviation from product specifications is unlikely to pose a serious risk and consequently could be overlooked. Similarly, notes that the cost of ensuring that finished product conforms to product specifications in the animal feed industry would be costly and would add little benefit for the health and welfare of the animal population or the health of consumers.

In risk management terms the intent, among other things, of process specifications is to prevent contamination or cross-contamination. This does not mean that the only acceptable target is zero risk of any kind of contamination. NZFSA agrees that it is impossible to prevent all forms of contamination. NZFSA also agrees that there are some kinds of contamination that pose insignificant or irrelevant risks. It is the feed manufacturer, not NZFSA, who sets the product specifications. It is reasonable to expect that the manufacturing process set by the manufacturer should be designed to deliver a product to those specifications. The important matter is that feed manufacturers should be aware of the risks their products pose, and take reasonable steps to avoid relevant manageable risks.

Suggests the sentence “‘Own use’ refers to a non-agricultural compound substance being used by a person on their own land ....” indicates that ‘own use’ does not apply to the manufacture of feed on farm for use on the farm. As such, seeks clarification on whether home millers would be required to implement the same controls as those noted for manufacturers.

Home millers who do not sell their feed to any other party will be subject to the own use requirements, and not the manufacturing requirements. Own use is not described in the same terms as manufacturing, but the same risks must be addressed. The only difference with own use is that third parties will not be exposed to those risks. A home miller who sells feed (which includes gives, exchanges, barters etc) will be subject to the same minimum manufacturing requirements as any other manufacturer.

Notes it is critical that the new public health proposal is not prescriptive, as pet food is not processed to human consumption standards. The new fit for purpose requirement must not require pet food be processed to a higher standard than currently required.

Agreed.

Contends the term ‘good manufacturing practice’ needs a new definition. In the current Regulations, Good Manufacturing Practice is defined as “a practice that that follows an Approved Operating Plan”. The Approved Operating Plan is, in turn, defined as “an operating plan approved under section 28 (2) of the Act”. Therefore the term needs to be redefined to something substantially different from what the ACVM Group have always used. The new definition of Good Manufacturing Practice should be outcome based such “that which results in a product which is fit for purpose”.

NZFSA agrees in regard to careful use of the term Good Manufacturing Practice (GMP). The term ‘approved GMP’ is not relevant to the manufacture of pet foods or any other animal feed. It specifically relates to the manufacture of veterinary medicines and some vertebrate toxic agents. NZFSA will ensure that drafting of the proposed amendment does not inadvertently impose GMP-type manufacturing requirements where they are not needed. NZFSA agrees in principle with the concept of responsible manufacturing being defined as “that which results in a product that is fit for purpose”.

Compliance will continue to be a problem for businesses that do not have risk management programmes (RMPs) under the Animal Products Act 1999 (the APA), as they are not engaged with NZFSA and often unaware of the existence of requirements. Suggests NZFSA’s ‘slice of life’ audits be more formal and frequent, and targeted towards perceived likely risk.

Regulatory control under the APA provides a good opportunity for regulated parties to know their requirement under both the APA and the ACVM Act, but it is not essential. Those parties who do not operate under an RMP still have to meet obligations under the ACVM Act. This is true for proprietors of all agricultural compounds exempt from registration that are not under the APA.

Supports manufacturing requirements for product specification, and for process specifications and controls. Submits it must be explicit that these be fit for purpose, outcome-based, and more flexible for products that pose lower risks.

NZFSA agrees that product and manufacturing specifications should be no more or less than what is necessary to ensure a product is fit for purpose; and that this should take into consideration the nature of the product and the potential risks.

Makes several requests to do with labels: define ‘trade name’, as it is not clear what it means for pet food; make explicit that a web address is sufficient; delete ‘additive’ as there are no active ingredients in an exempt pet food that provide nutrition only; clarify ‘direction for use’. Also comments, in regard to process specifications, that ‘must prevent’ is too prescriptive and should be replaced by ‘minimise’ or similar.

NZFSA agrees – all the comments on labels are reasonable and useful. The words ‘must prevent’ do not mean the target must be zero. In effect, the practical target must be to minimise down to an acceptable and achievable level.

Strongly supports the proposed exemption for research, testing, and training purposes, which will lower the regulatory burden on some companies. Submits that NZFSA should work with ERMA to develop a harmonised approach – ideally the same information that is notified to ERMA should be notified to NZFSA.

NZFSA has been working and will continue to work closely with ERMA to make the ACVM exemption from registration for carrying out research and the ERMA generic approval for research work as seamless as possible (while noting that this is not considered viable where products will enter the food chain, as such products pose greater food safety risks).

Welcomes proposal to create an exemption for compounds used for research, testing, or training, and urges NZFSA to harmonise its exemption with ERMA’s containment approval. Supports the list of conditions that may be appropriate.

See above response.

Supports proposed manufacturing requirements and agree that they will have little impact on responsible manufacturers. Agrees with the proposal that both registered and exempt agricultural compounds have an auditable system for their manufacture in accordance with good practice. Notes this is consistent with some other countries notably Australia and USA that also have requirements that impose quality production standards on agricultural chemicals (many exempt products – e.g. surfactants- in NZ are registered in other countries) without going as far as a formal licensing for compliance with Good Manufacturing Practice.

NZFSA notes that this submission appears to confirm the proposition that the proposed manufacturing requirements are already being met by responsible manufacturers.

Notes it would not oppose formal auditing of production records to show products are being manufactured according to specifications & allow traceability.

No comment.

Supports proposed advertising requirements, notes many suppliers sell registered and exempt products.

No comment.

Suggests the distinction between ‘research approval’ and ‘provisional registration’ will no longer be required.

For organisations that take advantage of the exemption, the distinction between research approval and provisional registration would virtually disappear. However, provision for data protection would not apply to research done under the exemption, while provisional registrations for innovative agricultural compounds could be covered by data protection provisions.

Submits that NZFSA must be able to take legal action as required against manufacturers and users. Notes the proposals should allow this to occur.

No comment.

Supports the addition of a ‘fit for purpose’ requirement for risks to public health. Notes also that making use of the phrase ‘fit for purpose’ is all encompassing, and should allow both manufacturers and regulators to come to a common, uncomplicated, understanding of their responsibilities.

This supports NZFSA’s view that the use of general terms such as ‘fit for purpose’ enables requirements to be appropriately flexible to apply to all exempt products.

Supports the proposed minimum manufacturing and advertising requirements, noting that based on the information provided, there should be little extra work required by manufacturers in order to comply with the proposed changes. All good manufacturers should have basic written processes that all their employees can follow. Adding a basic label as proposed will help farmers compare products, use the product safely and effectively, and allow them to make a complaint if the product is not to their satisfaction. Notes that the need to keep records will help farmers and NZFSA keep manufacturers accountable.

This supports NZFSA’s view that the new regulatory requirements will not have a significant impact on how responsible businesses operate.

Notes that no time length is recommended for how long evidence of compliance should be retained.

NZFSA did not specify a minimum time for retaining evidence of compliance; the default period would be the lifetime of the product.

Notes that own use is difficult to regulate, and will only be policed when an issue arises. Asks: “how will farmers know their obligations?” and “how will they know if requirements change?”

NZFSA agrees that regulating own use is problematic in principle, but notes that it is manageable in practice. The intent of the provision is to create a transparent context for own use to occur. The offences in section 55 are based on people acting in a manner that they know is not right. NZFSA’s initial approach to such people is to make them aware of the potential offence and make sure they understand that their action is not lawful. Prosecution is considered when dealing with people who continue to offend even after they have been advised against the action. Consequently, the concern about how the person is to know about their obligation is addressed by the first approach. In practice, most own use applications never come to NZFSA’s attention. Potential problems come to NZFSA’s attention while they are relatively insignificant, allowing enough time to put out guidance to avoid or minimise negative effects such as non-compliant residues. At this time there are no own use problems that would make the initial advice step unacceptably risky.

With regard to the proposed exemption for compounds used in commercial plant production, raises an issue around grazing of ground cover under trees or in nurseries that has been inadvertent sprayed. Asks: “how will an orchardist know of the risks?” and “how will a farmer know?”

NZFSA notes that the use of agricultural compounds on feed is outside the scope of the proposed exemption. In the scenario described, it is the responsibility of the parties involved to take due care with their products.

Nevertheless, to address the submitter’s point, NZFSA considers there could be a minimum labelling requirement on products being exempt from registration on the condition that they are not used in a food/feed context – this would warn users not to allow livestock that may enter the food chain to have access to the treated area. In the absence of assessment of residues and advice on appropriate withholding periods, that warning/advice should be very conservative.

It should be noted that maximum residue limits (MRLs) refer to the sale of food, making that target irrelevant if the produce is being personally consumed (i.e. part of one’s own food chain). In addition, MRLs are set far below the safety limits so they would be far too stringent as targets in such cases.

Comments that in areas of forest and waste land where mass spraying for exotic and indigenous pests may occur, the risk to the public must be managed. Asks: “where this type of spraying is to be carried out by non-government entities, with no reference back to regulators, how will this be managed?”

The proposed exemption only applies if the agricultural compound is not used in a food or feed context. If public land is being treated, the failure to post warnings and to prevent livestock access is likely to create circumstance in which the conditions of exemption could be breached. The obligation is on the party responsible for the treatment to address this potential, or to use some other product for which livestock exposure in a food/feed context has been addressed.

Plant compound: should be changed to ‘agricultural compound’ (not ‘agricultural chemical’).

This suggestion is not practical. ‘Agricultural compound’ is the more generic term; most of the provisions of the ACVM Act relate to agricultural compounds. ‘Agricultural chemical’ is a subset of that generic term.