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News and Views for September 2009

New public register close to launch date

The amended Agricultural Compounds and Veterinary Medicines (ACVM) Act requires more information (eg, responsible manufacturer, agent, addresses) to appear on the public register, so we are taking the opportunity to make the register more user friendly as well.

You will soon be able to see daily updates to the public register of registered ACVM trade name products, including any suspensions (see article below). You will also be able to check conditions of registration without going to a separate web page. These are just two of the improvements in the new register, which is undergoing final testing now and should be up and running by the end of the month.

Suspension — a new tool in the compliance toolbox

The amended ACVM Act increases the options available to NZFSA when dealing with non-compliance. Suspension of registration (section 30A) prevents the import, manufacture, sale or use of a trade name product (TNP) (unless a condition of the suspension allows otherwise) until the registration is restored.

Suspension may be considered by the Director-General when there are reasonable grounds to believe that a TNP or the actions of a registrant are non-compliant with any condition of registration and corrective action could be taken by the registrant in a short time. Suspension would be considered only if the non-compliance was confirmed and the remedial action could be specified. In such cases, the registrant may be given an opportunity to comply with the conditions of registration within a specified period (up to 3 months*) rather than have the registration immediately reassessed under section 29.

Registrant must be notified prior to suspension period

Prior to the start of the suspension, the registrant must be notified of:

• the reason for suspension

• the period of suspension (up to 3 months)

• the date or time of commencement (which must not be earlier than the date of notification)

• the remedial action that must be taken before a suspension can be lifted

• any other conditions or requirements and directions. Conditions may specify certain aspects of the suspension with regards to sale and use of product, including:

- continued use of the products in the marketplace

- continued sale and use of a limited quantity under specified circumstances, including urgent situations.

The notification must also advise the registrant of his/her right to request a statutory review of the decision. Information on the review process, particularly how to initiate a statutory review, should be provided.

Suspension notified in Gazette and ‘flagged’ on public register

Suspension of registration will commence immediately after public notification in the Gazette and will be ‘flagged’ on the ACVM public register. Conditions of suspension and a brief description of the reasons for the suspension will be noted on the register. (If the situation warrants wider coverage, NZFSA may advertise suspension through any mechanism considered appropriate.)

In a suspension, the Director-General or the delegate will specify the conditions or requirements and directions as well as NZFSA’s intended actions. This may include:

• audit of facilities/records

• prohibitions on import, manufacture, sale and/or use

• forced site closure.

Suspension lifted when non-compliance corrected

When the registrant has provided sufficient evidence that remedial action has been completed, or has initiated a remedial action program that the Director-General or delegate considers sufficient, the suspension status will be removed and the public register amended.

Consequences of failure to take remedial action

Failure to complete the necessary action in the allotted timeframe may result in the reassessment of the registration. This may lead to changes in the conditions of registration or even cancellation of the registration. Re-activation of a cancelled registration will not be permitted. An application for a new registration will have to be lodged.

Knowingly allowing or causing a product to be non-compliant with the conditions of registration or knowingly failing to comply with the conditions of registration is an offence under section 55(1)(c). A prosecution may be taken in addition to suspension of registration.

Suspension is not appropriate in all cases of non-compliance

Suspension of registration is not appropriate in cases where the product and the registrant are compliant with the conditions of registration but the conditions no longer fit the risk management needs. In such cases reassessment is the appropriate action. This includes cases in which:

• a condition imposed upon registration is no longer considered appropriate by NZFSA

• NZFSA identifies a significant change to the risk profile of a TNP that makes the current conditions of registration questionable.

Suspension of registration is not necessary (and most likely not appropriate) when the non-compliance with a condition of registration is the fault of someone other than the registrant. In such a case a prohibition notice may be issued under section 65 to restrict the product and the activity of the non-compliant party.

If the non-compliance is so crucial that product already sold poses a serious risk, the Director-General may direct a recall of that product under section 35G.

* The registrant is expected to complete the remedial action within the 3-month suspension period. However, if the registrant advises that some actions cannot be completed in this timeframe the delegate may consider extending the suspension for up to 3 more months. If the extension is not granted and the remedial action has not been completed, the registration may be reassessed under section 29.

Compliance — courts hand down record fines

We have a short, simple message when it comes to compliance — pay attention to the rules or pay the price. Two recent court decisions involving ACVM products make this message very clear.

Bypassing regulations proves costly

A Pukekohe man who illegally imported and sold counterfeit agricultural chemicals was fined $119,000 in a landmark case. Mark Freeman imported two shipments of counterfeit agricultural chemicals from China in 2005 and 2006, which he falsely labelled as fertiliser. (Fertilisers are exempt from the need for registration under the ACVM Act.)

Although the case was primarily a fraud issue, there were potential food residue implications. NZFSA tests found the products’ active ingredients were similar to registered products, but some had marked variations in concentration and purity. Content labelling was false and instructions for use, operator safety and withholding and container disposal were non-existent.

Freeman was fined $25,000 for two charges of selling agricultural compounds that are not the registered trade name products, and $4,000 for providing false or misleading information to an inspector. Global Hort Imports NZ (of which Freeman was sole director) was fined $70,000 for selling agricultural compounds that are not the registered trade name products and $20,000 for providing false or misleading information to an inspector.

The presiding judge said Freeman’s conduct was the most serious type of offending under the ACVM Act. “This was sustained, calculated and comprehensive illegal conduct which undermined the integrity of New Zealand’s regulatory oversight of the horticultural trade and New Zealand’s reputation for safe, high quality produce.” See the website for details.

Withholding periods avoid residues

A Waimate dairy farm company that sent bobby calves containing a prohibited drug to the works was fined a record-breaking $6,000.

Last year the company sent 35 bobby calves for processing. A randomly selected calf showed residues of sulphonamides, which are commonly used for the treatment of bacterial infections in cattle. Although this residue level does not pose a risk to human health, its presence in meat is prohibited. This prosecution could have been avoided if the required withholding period for the drug had been followed. See the website for details.

Proposed changes to ACVM Regs

Watch your website update notifications for the discussion document on proposed changes to the ACVM Regulations, which will be released for public consultation shortly. Your comments on the proposals will be welcome.

Aminoglycoside review completed

In response to the recommendations from the 2005 report of the Antimicrobial Resistance Expert Panel and the advice of the Antimicrobial Resistance Steering Group, NZFSA has reassessed veterinary medicines containing antimicrobials in the aminoglycoside class. The reassessment commenced 1 July 2009 and was completed 25 August 2009.

The recommendations of the Expert Panel and Steering Group concluded that for products containing aminoglycoside antibiotics the following should apply:

• Evidence of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside should be required at the time of their next registration.

• Oral aminoglycosides, alone or in combinations, should not be used to treat non-specific enteric infections in groups of food-producing animals. If used to treat gut infections, their selection should be confirmed by bacteriology and susceptibility testing.

The aim of the reassessment was to assess products in the groups identified by the Expert Panel to ensure there was adequate supporting evidence to justify their continued use in terms of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside anti-microbials and to ensure oral amingoglycosides are not marketed for use to treat non-specific enteric infections in groups of food-producing animals.

Some products not included in reassessment

There are good animal health and welfare reasons to retain injectable and topical aminoglycosides as restricted veterinary medicines. These were not included in the reassessment except for injectable combinations of aminoglycosides with β lactam antimicrobials. Topical preparations for use on skin, eyes or ears were not included.

Reassessment results

As a result of the reassessment, all injectable and intramammary products with aminoglycoside in combination with β lactam antibiotics were either withdrawn prior to the commencement of the review or were reassessed and found not to meet the requirements of the reassessment, so their registrations were declined.

Of the oral products included in the reassessment, the products containing a combination of aminoglycosides and other antimicrobials were withdrawn prior to reassessment or were reassessed and found to not meet the requirements of the reassessment. The oral products containing a single aminoglycoside antimicrobial active were reassessed and found to meet the requirements of the reassessment, following some label changes.

The products that had their registrations withdrawn or declined were gazetted on 27 August 2009. After a phase-out period, which ends 25 August 2010, it will be a breach of the ACVM Act to sell or use these products. During this phase-out year, product in the marketplace (stock in trade) may be sold, BUT product sitting on shelves in warehouses (where it is considered under the control of the registrant) may not be sold or distributed.

Any product gazetted is no longer registered. Therefore, it is illegal to import or manufacture product or to sell further product unless there is specific approval to do so.

New class determination forms

We are updating the class determination process. Although there are no changes to the current policy or guidance on conducting/requesting determinations, the request forms will change slightly. We will ask for more information in some minor areas (eg, listing the importer and the person responsible for the product’s compliance in New Zealand).

The changes are to streamline the process, implementing an online request form and collating all information on the website into one area. These changes should make the class determination procedure more efficient for both applicants and NZFSA, reducing time for both parties and charges for some class determinations.

The new forms and documents will be online in the next couple of months. Watch this space!

Magnesium oxide supplements — advice to suppliers

Magnesium oxide is an important supplement for New Zealand dairy cattle, and a number of products are available for this purpose. These products are exempt from registration if they meet the conditions of oral nutritional compounds listed in Schedule 4 of the ACVM Regulations.

If the products are sourced from manufacturers outside of New Zealand, it is particularly important that the New Zealand responsible agent (usually the importer or distributor) makes certain the product meets the requirements listed in Schedule 4. Requirements include ensuring:

• the product is ‘fit for purpose’

• any dose rates recommended can be justified for a New Zealand use situation

• the label contains:

- contact details for the New Zealand agent

- sufficient information to allow the product to be used as it is intended and in a safe and appropriate manner—this includes an accurate description of the product.

NZFSA has been notified of a number of magnesium oxide products that:

• do not provide adequate label instructions

• do not contain the level of magnesium listed on the label

• are not the particle size that is claimed.

This means that the products may not meet the requirements of Schedule 4.

Total Diet Study

Tests on locally produced food show the average New Zealand diet presents no chemical residue food safety concerns.

The first quarter results for the Total Diet Study were released in August. The five-yearly study tests more than 120 commonly eaten foods to estimate New Zealanders’ dietary exposure to chemical residues, contaminants and selected nutrients. (The survey is not intended to be a compliance survey, but any issues of non-compliance with allowable limits for residues or contaminants are followed up.)

Foods tested are split into two groups -- those from the regions and those available nationally. The first quarter tested 61 regional foods from supermarkets and shops in Auckland, Napier, Christchurch and Dunedin in January and February. Out of 60,000 analyses, just two areas required a closer look:

• tomatoes from Napier, where the pesticide azaconazole was found at slightly above the maximum residue limit (MRL) of 0.05 mg/kg. The level found does not pose a food safety or health concern but it does highlight the need for growers to ensure they follow good agricultural practice.

• breads from Napier, where higher than expected levels of lead were found. The levels did not pose a health concern.

For more details see 2009 New Zealand Total Diet Study.

Staff update: New vet to fill parental leave gap

Richard McKinley (Advisor ACVM Approvals: Animals)

We welcome Richard McKinley who has joined us on a 12-month contract to fill the gap that will be created when Lucy Johnston goes on parental leave (mid-October). By way of introduction, Rich had this to say.

“I am originally a Hawke’s Bay boy but since graduating as a veterinarian from Massey I have worked in the Bay of Plenty for 2 years and then the Manawatu for 8 months. Most of this time was spent with dairy cows and sheep and beef, with a bit of horse work thrown in.  I am also currently completing a business degree through Massey.

I am keen on my skiing, rugby, volleyball, squash……..the list goes on, and I am looking forward to getting into surfing this summer. I also enjoy spending time with friends, relaxing with a good book and spending time with the family back home at the beach.”

Heads up — new process in the new year

We plan to change the ‘holding pen’ part of the registration application process next year. At present, applications are sent to the delegated decision maker but are then held for final approval if they are deficient in some requirement (eg, ERMA, PDS or labelling). From January 2010, all deficiencies must be corrected before an application will be sent for approval. This will have no impact on statutory timeframes.

REMINDER: The new PDS forms must be used from now on. Applications submitted on the old forms will not be accepted.

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