2d Obligations on Veterinarians in regard to Product Safety Programmes/Milking Animal Health/MAF Standard D105

Policy

Veterinarians should supply sufficient information on services rendered and products dispensed or prescribed, in ways that enable farmers to comply with those aspects of MAF Standard D105 ”Milking Animal Health” that pertain to the supply of those products and services by those veterinarians.

Explanation

The Dairy Industry Act 1952 prohibits the sale of tainted or impure milk to a dairy or to a person for human consumption. The Dairy Industry Regulations (1990), mandated under the Dairy Industry Act (1952) require farm dairies to operate in accordance with Product Safety Programmes (PSPs) which ensure that milk that may be contaminated is excluded from sale and that records are kept to verify PSP compliance.

MAF Standard D105 “Milking Animal Health” outlines requirements for farmer handling of diseased and treated animals and their milk on farm, as well as records of such diseases and treatments. Records kept by farmers must be kept available for auditing purposes.

Product Safety Programme requirements apply to all farm dairies (bovine, ovine and caprine) and include farms supplying dairy companies, small manufacturers, as well as farm gate sales. In addition Dairy Companies are also required to run approved manufacturing PSP’s which must include processes to ensure that the milk they use is safe.

In this regard dairy farmers therefore have obligations in two areas:

1. in  law with respect to MAF Standard D105, and
2. by way of contract, with their Dairy Companies.

Farmers require information from, and are dependent on veterinarians, in order to comply with their legal and contractual obligations under MAF Standard D105.

The relationship between farmer and veterinarian is based on, and reliant on, two factors:

1. on contract. Failure, on the part of a veterinarian, to supply the information necessary for a farmer to meet his/her obligations, resulting in a Dairy Company either rejecting or refusing to accept milk, could result in civil action on the part of the farmer against the veterinarian.
2. a high standard of ethical conduct on the part of the veterinarian. S4.1 of the “Code of Professional Conduct for Veterinarians”, requires veterinarians to  “… act in a professional manner at all times when using, prescribing, selling or recommending veterinary medicines, particularly animal remedies.” This obligation extends beyond merely the supply of information in regard to animal remedies. It includes the reasonable supply of sufficient information on animals under veterinary care and treatment to enable farmers to comply with their obligations in law, including MAF Standard D105.

Veterinarians are therefore ethically and contractually obliged to supply this information and could face the dual risk of civil litigation or an action for professional misconduct under the Veterinarian’s Act by not doing so.

The New Zealand Veterinary Association views the obligation on the part of veterinarians working in this area as an opportunity for the profession to create business opportunities by providing excellent service, working alongside the dairy industry, building relationships, and supplying solutions to clients. Good farmer records of such information are likely to facilitate better management of treated animals and reduce penalties.

Furthermore veterinarians treating dairy animals are ideally placed to inform clients of farm occupiers requirements to comply with relevant product safety programmes and recording systems.

MAF Standard D105 sets out amongst other things the information required to be recorded by a dairy farmer. It does not prescribe the recording systems, but specifies that accurate records must be kept of animal diseases and treatments. These must be available for inspection by auditors to ascertain compliance with the PSPs.

Individual Dairy Companies have designed their own product safety programmes to comply with MAF Standard D105, so within the industry there is no requirement for uniformity with regards the form in which records are kept. Records may be kept in hard copy or electronic format, on or off farm. On farm access to records is mandatory so that information can be recorded when necessary. Third party suppliers off farm may store electronic records for farmers.

The purpose of PSP’s is to provide an auditable trail to ensure that assurances as to food safety can be verified. For this reason it cannot be overemphasised that the owner/farm occupier is obliged to provide records that can be traced back to individual animal treatments. Thus individual animal identification is a cornerstone of the programme, and both farm owner/occupiers and veterinarians have an obligation to ensure the integrity of animal identification.

Veterinarians should be aware that these information requirements, in many cases, exceed those which have traditionally been supplied following consultations. In many instances this will also result in quite considerable changes to the ways in which information is supplied. For example, in the past veterinarians have placed reliance on oral communication to convey to farmers information to ensure compliance requirements are met. This will no longer be sufficient. Information should be supplied in ways that not only facilitate farmer compliance, but also ensure that veterinarians are  able to verify that such information was supplied and are therefore protected in case of subsequent challenge as to whether or not relevant information was in fact supplied. In most instances the provision of written instructions would meet this requirement. This is particularly relevant when “off farm” consultations take place. For example, where practice labels are attached to containers of licensed animal remedies (so called “overlabelling”), it may be that essential label information is obscured. The provision of a hard copy form conveying all the information set out in Section 2 (a) to (k) of the “Guidelines” below, would overcome this. 

The information requirements set out in this policy document and the concomitant obligations imposed on a veterinarian, are sufficiently detailed, (as at June 2006) to cover the current legal obligations on that veterinarian with regards information supply relevant to MAF Standard D105, under the Medicines Act, the Dairy Industry Act, the Veterinarian’s Act and the Agricultural Compounds and Veterinary Medicines Act. They also incorporate the requirements on veterinarians under the Code of Practice for the Discretionary Use of Human and Veterinary Medicines by Veterinarians.

In cases of discretionary use veterinarians must follow the NZVA Code of Practice for the Discretionary Use of Human and Veterinary Medicines by Veterinarians. This Code can be found in Section B2.1.1 of the NZVA “Members Manual,” or in Appendix 1 of the “Code of Professional Conduct” published by the Veterinary Council of New Zealand.

The Code defines “discretionary use” as the use by or on the authority of a veterinarian of:

• a registered veterinary medicine in a manner not specified in the conditions on registration for the product, or
• a human medicine scheduled under the Medicines Act 1981 and exempted from registration under the ACVM Act, or
• a preparation specifically compounded, by or on the authority of that veterinarian, for use on animals in that veterinarian's immediate care. 

Guidelines

1. Information Requirements on Farmers
   MAF Standard D105.1 Appendix 1, Part 3 (“Veterinary Medicines”) and Part 6 (“Records”) require the “farm occupier “ to record the following information on individual animal diseases/treatments:
   1. a unique animal identifier;
   2. date sick/diseased animal removed/isolated from herd;
   3. type of disease;
   4. treatment details;
   5. date milk withheld;
   6. date animal returned to herd;
   7. Name of veterinarian consulted (if applicable).
   8. Records must be kept available for auditing and traceback purposes and held until the end of the following season.
2. Information Requirements on Veterinarians
   A veterinarian should provide the following information to farmers in regard to animal remedies used/ dispensed/prescribed following veterinary consultations:
   1. Name of prescribing veterinarian, practice name, address and 24 hour telephone number;
   2. The identity of the animal or group to be treated;
   3. Owner’s or owner’s agents  name, species and purpose for which drug supplied or prescribed;
   4. Product name, strength and volume (or number in the case of boluses or pills);
   5. Date dispensed or prescribed;
   6. Directions for use, including dose rate, frequency of treatment, route and method of treatment, and duration of treatment;
   7. Essential warnings if necessary (e.g. for external use only, special storage conditions, and any special considerations in regard to operator safety);
   8. Witholding periods (days or number of milkings);
   9. The active ingredient (if compounded for discretionary use);
   10. In cases of discretionary use the information that the use is discretionary.
   11. In order to facilitate farmer compliance with the MAF Standard D105, following a veterinary consultation in regard to relevant animals covered by the Standard, a veterinarian should provide the following additional information in addition to the relevant material referred to in a) to j) above:
   12. Type of disease/condition;
   13. Treatment details.
   14. When products are dispensed in containers other than those provided for under license/registration conditions (for example in syringes) the obligation on veterinarians remains undiminished and all the information requirements contained in  (a) to (k) above apply.
3. Obligations on Veterinarians When Prescribing or Dispensing PARs Off Farm
   Veterinarians have the same obligations to supply the information detailed in (a) to (j) above when supplying/dispensing PARs off farm that apply when prescribing/dispensing such products on farm. In practice this will mean changes to traditional methods of supplying information.
4. Obligations on Veterinarians When Supplying “Over The Counter” Products Off Farm
   The obligations specified in this policy document do not apply to the sale of “over the counter” products by veterinarians or veterinary practice staff.
5. Record of Information Supplied
   It is recommended that veterinarians be able to validate the supply of all relevant information referred to in points (a) to (k) above. For this reason it is advisable for a veterinarian to retain a written or electronic record of relevant information supplied in order for a farmer to be able to comply with the Standard.  This may take the form of a copy of a standardised form left with the farm occupier/ client. A sample of a suitable form is attached to this policy document. Electronic copies of this sample form can be downloaded from the NZVA website on www.vets.org.nz.

   MAF Standard D105 does not prescribe the form in which relevant information should be supplied or recorded by the farmer. Individual Dairy Companies may have designed and supplied their own recording systems to facilitate farmer compliance.

   Where a farmer has a Company supplied hard copy recording “book” for the purposes of compliance either the veterinarian or farmer may complete the relevant sections.  Written communication in such books by a veterinarian may enhance the clarity of the record but is not necessary. In cases where a veterinarian fills in such books it would be prudent for the veterinarian to append his/her signature with the information supplied.

6. Storage of Records
   Records of information supplied should be treated as normal business/ professional records and be kept for the same period.

Policy Files: 

2d - Product Safety - 18Aug06.pdf

2d(i) - Product Safety APPENDIX - 18Aug06.pdf