Guidelines for data to support efficacy and safety of teat disinfectants

1. Introduction

In determining whether a chemical product is suitable for registration, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the product is safe and effective and will not unduly prejudice trade.

The information required with applications is set out in the legislative instrument for application requirements. Technical data or strong scientific argument should be provided to address safety, efficacy and trade criteria.

These guidelines address how the efficacy criteria can be met for the registration of pre and post-milking teat disinfectants in Australia. They are based on principles recognised by the global scientific community and Australian dairy industry as appropriate for collecting the scientific data on target animal safety and efficacy. The guidelines address the two key areas of interest:

  • Efficacy—bactericidal efficacy of the teat disinfectant.
  • Target animal safety—potential irritancy of the product to teat and udder skin.

These guidelines do not include public health (including milk residues) or environmental safety considerations, which are covered in other data guidelines available on the APVMA website.

Pre-application assistance or technical assessments of trial protocols and/or data under Item 25 are available to applicants seeking general or specific technical advice regarding a proposed application.

These guidelines should be read in conjunction with data guidelines for registering veterinary chemicals.

All trial protocols must be approved by an Animal Care and Ethics Committee before any animal experimentation. Separate approval for the supply and use of unregistered chemicals for use in research is also required prior to any clinical trial work being commenced.

2. Efficacy

This section gives guidance on demonstrating that the product meets the efficacy criterion and should be read in conjunction with the efficacy and target animal safety general guideline (Part 8).

The APVMA must be satisfied that every product meets the efficacy criteria. The efficacy criteria must be considered for every new product and for every variation to a registered product where the variation may impact product efficacy. Efficacy of the product can be demonstrated by:

  • relying on an Australian registered reference product
  • provision of in-vitro and/or clinical data generated in Australia or overseas
  • provision of scientific argument.

2.1. General principles

The applicant should demonstrate that the proposed product is efficacious (supports label claims) if used according to label directions under climatic conditions similar to those experienced in the Australian dairy industry. This may require both in vitro and clinical trial data.

International clinical trial data, registration status and history of use can be used to support efficacy. International data must be generated in a jurisdiction acceptable to the APVMA, and undertaken according to internationally recognised protocols.

If clinical data is generated overseas, a confirmatory Australian study is required and depending on application type a scientific argument may be submitted in-lieu of the local study.

Clinical trial data generated from another species is of limited value. This data may be included as supportive evidence of efficacy, but cannot replace clinical studies on the target animal species.

Further guidance for applicants on expectations for efficacy data is provided in Table 1.

Table 1: Guidance on the type of efficacy data expected to be provided in support of common teat disinfectant product application types

Product/application description

In-vitro data

Clinical data

Approval of an active constituent (new actives) contained in a teat disinfectant product, registration of the associated teat disinfectant product and approval of the product label.

Yes

Yes

 

Data from Australia required from at least 2 clinical studies conducted during a time when the risks of clinical mastitis are high, such as in herds on pasture during ‘wet and muddy’ conditions in southern Australia, or in intensively housed herds.

 

If product is registered overseas: Overseas data AND Australian data from at least 1 ‘local’ study as per the above requirement.

Registration of a new teat disinfectant product containing an approved active constituent and approval of the product label.

Yes

Yes

 

Data from Australia

 

OR

 

Overseas data AND:

 

  • Australian data from at least 1 ‘local’ study conducted during a time when the risks of clinical mastitis are high, such as in herds on pasture during ‘wet and muddy’ conditions in southern Australia, or in intensively housed herds, 

OR

 

  • scientific argument on relevance to Australian use situation and that the susceptibility of pathogens used in the trial(s) are the same as the common mastitis pathogens isolated in Australia.

New teat disinfectant product that is defined as ‘similar’ to a registered teat disinfectant product.

Yes

Yes

Data from Australia

 

OR

 

Bioequivalence studies

 

OR

 

Scientific argument based on supportive local or international data and history of use may be sufficient to demonstrate bioequivalence.

New teat disinfectant product that is defined as ‘closely similar’ to a registered teat disinfectant product.

Not usually required

Not usually required. It is recommended that applicants seek advice from the APVMA through a PAA.

Variation application involving major formulation change to a registered teat disinfectant product

Yes

Yes

 

Data from Australia

 

OR

 

Overseas data + scientific argument on relevance to Australian use situation, and that the susceptibility of pathogens used in the trial(s) are the same as the common mastitis pathogens isolated in Australia.

Variation application involving minor formulation change to a registered teat disinfectant product or formulation change based on a registered reference product.

Not usually required

Not usually required.

Tailored guidance material can be accessed on the APVMA website to assist applicants to lodge the right application, with the right data and supporting evidence to meet APVMA criteria.

Where a registered reference product is used as part of the application it is recommended that applicants are familiar with the APVMA’s ability to access information attached to these products.

2.1.1. International data and assessments

International data can be considered for all application types where the data is relevant to the use proposed in Australia. The APVMA has developed criteria to clearly indicate how international data, standards and assessments can be used as part of the risk assessment process for the approval of an active constituent, registration of a product or approval of a label.

2.2. In vitro testing

This section should be read in conjunction with the efficacy and target animal safety general guideline (Part 8).

2.2.1. General principles

In-vitro studies demonstrating the efficacy of the product on the common mastitis pathogens must be provided to verify disinfectant action and underpin subsequent clinical studies.

The common mastitis causing pathogens in Australia (in housed and pasture-based systems) are Staphylococcus aureus, Streptococcus agalactiae, Streptococcus uberis, Streptococcus dysgalactiae, Escherichia coli and Pseudomonas aeruginosa. The isolates used in the in-vitro testing must be sourced from cases of mastitis but do not have to originate from Australia.

In-vitro data can be generated in laboratories under GLP in Australia or overseas according to recognised international protocols.

In-vitro data cannot be used as the sole basis for claims of efficacy.

The proposed product formulation (final solution) should qualify as an antiseptic by in-vitro testing.

The product formulation used in the in-vitro studies must be identical to that being proposed for registration.

Where the applicant wishes to make a label statement for inclusion of extra emollient, additional in vitro efficacy data must be provided to support the efficacy of the product containing this extra emollient.

2.2.2. Experimental design

One or more of the following Standard Methods for testing are recommended:

  1. BS EN 1656:2009 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area. Test method and requirements (phase 2, step 1).
  2. AOAC 960.09 Germicidal and Detergent Sanitising Action of Disinfectants.

These methods are complete end-point methods that require, within the experimental error, a 5 log10 reduction or 100 per cent kill of the test organisms. A contact time of 30 seconds in the presence of one per cent milk is appropriate for teat disinfectants.

If the product is to be diluted with water prior to use, the in vitro testing should be conducted using tap water or clean rain water as a substitute for ‘cooled, boiled dairy heater water’.

Most teat disinfectants have a ‘useful life’ after preparation (based on stability data), and label instructions are given to ensure the product is used within that time frame (for example ‘Mix fresh solutions daily’ is a common direction for several iodine concentrate products). If a ‘useful life’ is defined on the product label, the in vitro testing should test product at the limit of its useful life (ie test the solution 24 hours after being diluted in the above example).

Additional in vitro studies may need to be carried out if specific statements concerning water quality are to be included on the label directions (either as restraints or claims).

2.2.3. Reporting

A report signed by the principal investigator needs to include the following as a minimum:

  • trial number/ID
  • name and address of principal investigator
  • methodology used and a description of the experimental conditions (contact time, temperature, temperature of incubation)
  • a description of the product tested (product name and concentration)
  • list of microbial strains (mastitis pathogens) tested
  • description of the water quality used (if product requires dilution)
  • a table summarising the test results (validation and verification)
  • a statement of conclusions.

2.3. Local clinical studies (in vivo field trials)

This section gives guidance on the design of ‘local’ clinical trials to be conducted in Australia on the target animal species, to support the data from international efficacy studies based on internationally recognised NMC protocols.

This section should be read in conjunction with the efficacy and target animal safety general guideline (Part 8).

2.3.1. General principles

Clinical data from trial(s) conducted in Australia or under comparable international conditions on the target animal species must be used to support the in vitro efficacy studies.

Product formulation and use patterns used in the ‘local’ clinical studies must be identical to those being proposed for registration.

If the product’s ‘directions for use’ include changing the product concentration/mix to suit various environmental conditions, the recommended product concentration/mix should be used for the environmental conditions experienced during the trial period. In vitro experiments investigating the efficacy of the product at different concentrations/mixes would provide sufficient evidence for efficacy at different product mixes.

The application of teat disinfectant with a hand-held spray device or dip cup are the default methods of application in the Australian dairy industry. Trial(s) should include the different method(s) of application listed in the ‘directions for use’, for example ‘to be applied by teat scrubber’.

The efficacy data presented must support the ‘statement of claims’ on the label. Acceptable label claims are tabulated below.

Table 2: Acceptable level of evidence for label claim

Claim

Evidence/data required (international or ‘local’)

‘For the reduction in the herd incidence of infectious mastitis caused by (insert species)’

Negatively controlled trial(s) showing significant statistical reduction in the incidence of new intra-mammary infections caused by specific bacterial species (confirmed by culture),

 

AND/OR

 

A positively controlled, non-inferiority trial comparing a product having this claim (need specific microbiology).

‘For the reduction in the herd incidence of infectious mastitis’

Negative control trial(s) shows significant statistical reduction in the incidence of new intra-mammary infections,

 

AND/OR

 

A positively controlled, non-inferiority trial comparing a product having this claim.

‘To aid in the prevention of mastitis’

Negatively controlled trial(s) demonstrating no incidence of new intra-mammary infections in treated groups with intra-mammary infections evident in the negative control animals. Specific bacterial species to be identified,

 

AND/OR

 

A positively controlled, non-inferiority study showing no increase in the incidence of new intra-mammary infections between treatment and control groups allowing for the non-inferiority limit.

2.3.2. Trial site considerations

The satisfactory conduct of the trial is the responsibility of the principal investigator, including the responsibility to meet any legislation.

Clinical trial work should be undertaken using animals in early lactation on commercial dairy farm(s).

The farm chosen should have a history of the prevalence of clinical mastitis being at least 10 per cent of the herd per year. Higher numbers of new intra-mammary infections (clinical and subclinical) during the trial period will increase the likelihood of identifying a statistically significant effect. Conducting trials in herds with a lower prevalence is possible but care needs to be taken to ensure the trial will have sufficient power.

The farm(s) chosen must have suitable infrastructure and labour resources to ensure treatments are consistently applied according to label directions.

The farm(s) chosen should have suitable infrastructure (restraint) to enable the safe handling and treatment of animals.

The animals must be under the supervision of an experienced herd manager during the trial period(s).

2.3.3. Experimental design

In most instances a positive control, split herd design will be suitable. The positive control used must be registered in Australia and for which the APVMA holds efficacy and safety data. The positive control must be a product that is justified and proven to be efficacious in both experimental and natural challenge trials. Applicants may submit an enquiry via enquiries@apvma.gov.au to ascertain if the APVMA holds data for the proposed positive control.

 Alternatively, a negative control, split herd design can be used with appropriate animal welfare considerations. Under this design, for the test treatment group, all four quarters are to be treated according to the proposed label instructions using the test product. The negative control animals will have all four quarters untreated.

Efficacy is determined by:

  • assessing the number of new clinical cases over the trial period (teat is experimental unit)
  • assessing the number of new sub-clinical cases over the trial period (cow is the experimental unit)
  • analysing if a statistical difference exists in the above between the treatment and control groups.

Obtain biometrical advice prior to the trial to ensure that statistically valid numbers and methods are used.

2.3.4. Cow selection

The number of cows enrolled in the trial should achieve an 80 per cent power of detecting a difference in the incidence proportion (cumulative incidence) of new intra-mammary infections between treated and control groups with a 95 per cent confidence interval over the trial period.

As guidance, the following sample sizes are suggested to identify a statistically significant difference in the proportion of new intra-mammary infections over a 13 week trial duration:

Table 3: Suggested sample sizes to identify statistically significant differences in new intra-mammary infections

Difference in incidence proportions of new intra-mammary infections between treated and control groups

Cow numbers required in each treatment group*

0.05

686–1565

0.1

199–388

0.15

100–173

0.2

62–97

0.25

43–62

0.3

32–42

0.4

20–23

*If new intra-mammary infections are very rare or very frequent in the control group then higher cow numbers within the range are required. Note that the cow numbers relate to each group (so a trial with a ‘treatment’ and a ‘control’ group will need at least double the number of cows specified in the range to be enrolled).

It is advised that the trial is conducted in a herd where the number of clinical cases expected to be seen over the trial period will not limit the ability to draw statistically valid conclusions, after allowing for cows being excluded or lost from the trial.

The control and treatment groups should include a mixture of cow ages (primi-parous and multi-parous cows).

Cows with grossly deformed or injured teats should not be included/be removed from the trial.

Cows with an ICCC result above 200,000 cells/mL in the pre-trial period (week 0) must be excluded from the trial data.

Cows diagnosed with clinical mastitis in the period before the trial commences (in the same lactation) or in the pre-trial period (week 0) must be excluded from the trial data.

The data from cows that receive any intra-mammary or intra-muscular antibiotic treatments during the trial period must be excluded from the date of treatment until the trial is completed.

As this trial protocol aims to identify new intra-mammary infections, cows diagnosed with clinical mastitis during the trial period (week one onwards) must be removed from the trial and receive appropriate treatment. Their records for the first case of clinical mastitis should be included in the results, but not the records of any subsequent intra-mammary infections (cases of clinical or sub-clinical mastitis).

2.3.5. Trial duration

The length of an efficacy study will depend on the number of ‘uninfected’ quarters available initially and on the rate of new intra-mammary infections in the control and treatments groups.

However, the trial period must extend over at least 13 weeks during a period where the cows are subject to increased risks of contacting an intra-mammary infection—either during ‘wet and muddy’ conditions on pasture or when managed in housed environments or on feed pads.

2.3.6. Criteria for determining ‘new intra-mammary infections’

The criteria for determining ‘new intra-mammary infections’ should be based on the most recent industry guidelines. The current definitions and guidelines for identifying uninfected quarters and diagnosing new intra-mammary infections are published by Dairy Australia through the Countdown project and include both clinical and sub-clinical infections.

The techniques for detecting, and the diagnostic signs of clinical mastitis are described in Technote 4.1. An aseptic quarter milk sample for microbiological culture should be taken from the affected quarter prior to the quarter being stripped and treated as per usual farm protocols. The technique for taking aseptic samples for milk culture is described in Countdown Fact Sheet A.

A new case of sub-clinical mastitis is deemed to have occurred when an ICCC moves from below 200,000 cells/mL to above 200,000 cells/mL for the first time during the trial period. Subsequent movements in cell count above or below this threshold must not be included in the analysis of results (ie as ‘cures’ or ‘new infections’). Sampling quarters for culture (to identify the affected quarter and pathogen) from sub-clinically infected cows is not mandatory, but if completed, may enhance the ability of the applicant to make specific label claims about particular bacterial species.

ICCC of cows enrolled in the trial should be quantitatively monitored via monthly herd test or by an alternative suitable and validated cow-side or in-line testing methodology.

Microbiological culture for the common infectious mastitis pathogens must be completed at a commercial laboratory competent in undertaking veterinary microbiological testing.

2.3.7. Pre-treatment period (week 0)

The pre-treatment period includes one week (T = –7 to T = –1) before the treatments are applied.

Daily monitoring of BMCC commences.

A water test for alkalinity, hardness, organic matter and chlorine concentration is undertaken on the water to be used to dilute any teat disinfectant ‘concentrate’ that is used in the trial.

The cows are selected and treatment groups established and identified (based on odd or even cow number, or another suitable structure).

ICCC measurement is undertaken once during this period to establish a baseline.

Treatment groups are finalised after excluding cows that do not meet the inclusion criteria.

2.3.8. Treatment period (week one onwards)

The treatment period is expected to be a minimum of 12 weeks while the cows are in early lactation. This period should include ‘wet and muddy’ conditions.

Teat disinfectant treatments must be mixed and applied according to label/manufacturer’s directions, ensuring consistently good coverage of all four teats of every cow at each milking.

Daily monitoring of BMCC continues.

ICCC measurement is undertaken at weeks four, eight and 12, or more frequently.

Cases of clinical mastitis identified during the trial period are recorded, prior to the cow being removed from the trial for treatment. Cases of sub-clinical mastitis identified during the trial period may stay within the treatment group and should be managed according to the farm’s normal protocols.

Cows are eligible for a single intra-mammary infection, including both clinical and sub-clinical, during the trial.

The treatment period should continue until a minimum of 100 new intra-mammary infections have been identified (split between the groups), unless power calculations dictate otherwise.

No data collection is required after the treatment period has expired.

2.3.9. Data analysis

The data collected during the trial must be statistically analysed.

Efficacy data should be analysed with regard to the difference in the proportion of new intra-mammary infections identified in the treatment and control groups over the trial period (difference in the incidence proportion or cumulative incidence).

Statistical difference is to P = 0.05.

BMCC requires no analysis, being used by the herd manager to highlight potential issues to the principal investigator that may need further investigation.

2.3.10. Reporting

A report signed by the principal investigator needs to include the following as a minimum:

  • Trial number/ID
  • Name and address of principal investigator
  • Name and address of farm at which the trial was conducted
  • Description of the cows’ management (herd size, housing, milking frequency, calving pattern, annual production, initial BMCC at week one)
  • Trial dates and a description of the environmental conditions (maximum & minimum temperature, rainfall, housing/grazing conditions) during the trial period
  • The number and a description of animals in each treatment group (cow number, breed, age, days in milk, daily milk production and ICCC at the start of the trial)
  • Description of the chemical product used in the trial, including whether additional emollient was used in the test or control products
  • A description of the water source and quality (if any) used to dilute the chemical product(s). Quality tests should include water alkalinity, hardness, organic matter and chlorine concentration
  • Dates and results of ICCC measurements
  • Details of new intra-mammary infections (date, cow ID, treatment group, clinical/sub-clinical case, quarter affected, culture result (if any), treatment given)
  • Details of any animals included in the trial that were removed during the trial period (date, cow ID, treatment group, reason for removal)
  • Details of any deviations from the trial protocol
  • A summary results table showing the number of new intra-mammary infections (clinical and sub-clinical) by month in the treatment and control groups, over the trial period
  • A summary table showing the number of isolates of the various microbiological species identified in the treatment and control groups
  • The statistical analysis of the results
  • A statement from the principle investigator (following the trial) on whether in their opinion the test product has similar efficacy as the control product when used on the target animal species as specified by the manufacturer’s directions under the environmental conditions tested

3. Target animal safety

This section gives guidance on how to demonstrate that a teat disinfectant meets the safety criterion with respect to the target animal. This section should be read in conjunction with the efficacy and target animal safety general guideline (Part 8).

The APVMA must be satisfied that every product meets the safety criterion with respect to the target animal. The safety criterion with respect to the target animal must be considered for every new product and for every variation to a registered product where the risks to target animal safety may have changed due to the variation.

Safety to the target animal can be demonstrated by:

  • relying on an Australian registered reference product
  • provision of scientific argument to demonstrate product safety to the target animal
  • provision of data to demonstrate product safety to the target animal.

3.1. General principles

Clinical data from the target animal species is required to support target animal safety. In vitro data or data generated from another species may be supportive but is generally insufficient in itself.

Target animal safety data can also be collected during the clinical trial(s) being undertaken to generate efficacy data.

International clinical trial data, registration status and history of use can be used to support safety.

If the proposed formulation is sold as a concentrate (non-ready to use), use of the undiluted formulation in clinical trials is recommended. Where the concentrated formulation poses a greater risk to the animals, applicants should contact the APVMA to discuss alternative methods.

3.2. Trial site considerations

The satisfactory conduct of a trial is the responsibility of the principal investigator, including the responsibility to meet any legislative requirements.

Clinical trial work must be undertaken using lactating animals, preferably on commercial dairy farm(s).

The farm(s) chosen should have suitable infrastructure (lighting and restraint) to enable the safe and thorough examination of individual teats.

The farm(s) chosen should have suitable infrastructure and labour resources to ensure treatments are consistently applied according to the label / manufacturer’s directions.

The animals must be under the supervision of an experienced herd manager during the trial period(s).

3.3. Experimental design

In most instances a positive control, split herd design will be suitable. Under this design, for each treatment group, all four quarters are to be treated according to the manufacturer’s instructions using either a currently registered teat disinfectant (positive control) or the test product.

Cows should be allocated to different experimental groups based on ID number (odds and evens) or any other method which ensures the groups are similar in terms of age, breed and milk production. Avoiding leg bands or other experimental tags helps to obtain ‘blinded’ data from teat assessment, but the use of such methods may be necessary to ensure the consistent application of treatments.

Target animal safety (teat skin irritancy) is determined by:

  • assessing the change in teat score of teats over the trial period (teat is experimental unit)
  • monitoring and assessing the change in cows over the trial period (cow is the experimental unit)
  • analysing if a significant statistical difference exists over time between the treatment and control groups.

3.4. Cow selection

A minimum sample of 25 cows is recommended for each treatment group (minimum of 50 cows in total). It is advised that a small additional allowance is made for any cows that may leave the herd during the trial period.

The control and treatment groups should include a mixture of cow ages (primi-parous and multi-parous animals). The stage of lactation is not critical for target animal safety studies.

Cows with one or more light coloured teats should be preferentially selected for inclusion.

Cows with a high cell count or history of mastitis are suitable for inclusion.

Cows with grossly deformed or injured teats should not be included in the trial.

Cows diagnosed with clinical mastitis in the pre-trial period (week 0) should not be included in the trial.

3.5. Evaluation of skin reactions

At each examination, the condition of each teat in a sample of cows should be scored according to the protocols published by Dairy Australia under their Countdown project. A teat scoring recording sheet is also published by Dairy Australia.

Examination of the teats should be carried out immediately after ‘cups off’ by an experienced veterinarian or other competent assessor that has attended a Countdown Advisor Short Course, and so has been trained in the Australian teat scoring protocol.

Teat scoring should be blinded if possible (ie assessors are unaware of which treatment group individual animals have been allocated to).

The periodic scoring of the teats over the trial period should be carried out by the same assessor.

3.6. Evaluation of milk quality

Individual Cow Cell Count (ICCC) of cows enrolled in the trial should be quantitatively monitored via monthly herd test or by an alternative suitable and validated cow-side or in-line testing methodology.

Bulk Milk Cell Count (BMCC) should be monitored daily via milk company reports, with sudden changes reported to the principal investigator for further follow-up investigation if required.

3.7. Trial duration

The target animal safety trial should be conducted on a farm for a minimum of 13 continuous weeks and include environmental conditions that are detrimental to teat health (usually ‘wet and muddy’ conditions).

3.8. Pre-treatment period (week 0)

The pre-treatment period includes one week (T = –7 to T = –1 days) before the treatments are applied.

The cows are selected and treatment groups established.

Teat scoring and ICCC measurement is undertaken once during week 0 to establish a baseline.

Daily monitoring of BMCC commences.

A water test for alkalinity, hardness, organic matter and chlorine concentration is undertaken on the water to be used to dilute any teat disinfectant ‘concentrate’ that is used in the trial.

3.9. Treatment period (weeks one–12)

The treatment period on each farm is expected to be a minimum of 12 weeks, and would usually be timed to include ‘wet and muddy’ conditions.

Teat disinfectant treatments should be mixed and applied according to label/manufacturer’s directions (appropriate to the environmental conditions), ensuring consistently good coverage of all four teats of every cow at each milking.

Teat scoring is undertaken twice during week one, approximately 48 and 96 hours after treatments have commenced.

Thereafter teat scoring is undertaken once during weeks three, seven and 11.

ICCC measurement is undertaken at weeks four, eight and 12 or more frequently.

No data collection is required after the treatment period has expired.

3.10. Data analysis

The data collected during the trial should be statistically analysed.

Teat scoring data should be analysed with regard to the change in the teat score of each individual cow or sample of cows at each time point over the trial period. Short term changes are seen in week one (two assessments). Medium term changes are seen from weeks three to11 (three assessments). Differences in the change seen over time between individuals in the control and treatment groups should then be examined.

ICCC data should be analysed with regard to the change in the ICCC of each individual cow at each time point over the trial period. Differences in the change seen over time between individuals in the control and treatment groups should then be examined. It is recognised that the low cow numbers and natural variability of ICCC results is likely to challenge the statistical validity of results for this parameter.

Target animal safety should be analysed with regard to the difference in teat scores between the control and treatment groups over the trial period.

BMCC requires no analysis or reporting, being used by the herd manager to highlight potential issues to the principal investigator that may need further investigation.

The teat scoring data from cows diagnosed with clinical mastitis during the trial should be included in the analysis until the point that they are removed from the trial (for treatment).

3.11. Reporting

A report signed by the principal investigator needs to include the following as a minimum:

  • Trial number/ID
  • Name and address of principal investigator
  • Name and address of farm at which the trial was conducted
  • Description of the animals’ management (herd size, housing, milking frequency, calving pattern, annual production, initial BMCC at week 1)
  • Trial dates and a description of the environmental conditions (maximum and minimum temperature, rainfall, housing/grazing conditions) during the trial period
  • The number and a description of animals in each treatment group (cow number, breed, age, days in milk, daily milk production and ICCC at the start of the trial)
  • Description of the chemical product used in the trial, including whether additional emollient was used in the test or control products
  • Description of the water source and quality (if any) used to dilute the chemical product(s). Quality tests should include water alkalinity, hardness, organic matter and chlorine concentration
  • Dates and results of teat scoring and ICCC
  • Description of any transient deterioration in teat condition or other obvious clinical conditions that may have resulted from the application of the test product
  • Details of any animals included in the trial that were removed during the trial period (date, cow ID, treatment group, reason for removal)
  • A summary results table showing the change in teat score and ICCC at each evaluation point, in the treatment and control groups, over the trial period
  • The statistical analysis of the results
  • A statement from the principle investigator (following the trial) on whether, in their opinion, the test product is safe to use on the target animal species as specified by the manufacturer’s directions under the environmental conditions tested

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