The Ministry of Health has published the report on the results of the National Residual Plan for 2020. The activity is prepared annually by the ministry, based on the guidance provided by European standards, and implemented together with the competent regional and local authorities, the Experimental Zooprophylactic Institutes and the National Reference Laboratories.
The National Residue Plan (NRP) is aimed at searching for residues of pharmacologically active substances and chemical contaminants in live animals, their excrement and biological fluids, animal feed and drinking water as well as in tissues and food of animal origin, with the objective of unraveling cases of illicit administration of banned, unauthorized or used under conditions other than those authorized, verifying compliance of food with MRLs and maximum levels established by relevant legislation.
Sampling is performed unexpectedly, unexpectedly, and in ways that ensure the ‘surprise factor’ in controls at farms and first-processing establishments (e.g., slaughterhouses).
The NRP 2020 activity in Italy
Global activity
Under the whole activity of the National Residual Plan, in 2020 are:
- 32,564 samples were taken
- For a total of 401,682 analytical determinations
- compared to previous years, there is substantial constancy in the number of samples taken, with a slight decrease in the last year, but an increase over the years of the
- Number of analytical determinations.
Within the whole activity, 47 non-compliant samples were found, broken down as follows (Table 5):
Bear in mind that since these are nonconformities found in activities with different sampling strategies, it is not meaningful to compare the total number of nonconformities with the total number of samples taken.
Unsuitable samples
Compared with the previous year, there is a decrease in the number of unsuitable samples destined for analysis, denoting a significant improvement in matrix sampling procedures. Of the total number of samples taken, in fact, 117 of them were found to be unsuitable for different reasons such as:
- Incorrect rates (10)
- Samples canceled by ASL (3)
- Sample conferred over two working days (18)
- Poor state of preservation (15)
- Irregular packaging (6)
- Matrix not provided for in the NRP (15)
- Insufficient quantity (14)
- Incorrectly completed minutes (3)
- Other (5)
The Plan
Sampling activities
Depending on national and regional productions, a targeted plan is drawn up by the Ministry, broken down as follows for 2020:
From the table above, some critical issues in the system emerge, namely the failure to meet community targets for pigs and poultry, while the critical issue, found in past years, on hunted game is resolved.
The reason for the failure to meet national, and especially EU, targets lies mainly in the difficulties experienced on the ground due to the pandemic emergency experienced during 2020, which put pressure on the health systems of many regions, which are responsible for official food control activities.
Regional sampling activities
n.a.: not applicable due to lack of programming
Sampling activities coordinated by UVAC.
In addition, there are sampling plans on cattle, equids, sheep and goats, and pigs from member states destined directly for slaughter that are programmed outside the NSIS/PNR computer system but still need to be reported to portal in order to allow EFSA to process the data and results.
Therefore, however, the critical issue regarding the non-reporting of several samples (totaling 145, or 13.4 percent of the total) in the NSIS/PNR system remains confirmed, affecting their submission to EFSA.
The analytical activity
On a purely methodological level, using multi-residue analytical techniques, groups of molecules are researched in order to ensure coverage of the analyses required by EU standards.
The 30,029 samples taken under the Targeted Plan were analyzed for both:
- Group A substances – Banned and unauthorized substances (42.7%)
A – Substances with anabolic effect and unauthorized substances A1 – Stilbenes, their derivatives and their salts and esters
A2 – Antithyroid agents A3 – Steroids
A4 – Resorcylic acid lactones (including zeranol) A5 – β-agonists
A6 – Substances included in the All. IV of Regulation (EEC) No. 2377/90 of June 26, 1990 (now repealed by Council Regulation (EC) No. 470/2009 and Regulation (EU) No. 37/2010)
- Group B substances – authorized drugs and contaminants (68.3 %)
B – Veterinary medicines and contaminating agents.
B1 – Antibacterial substances, including sulfonamides and quinolonics
B2 – Other veterinary medicinal products B2a – anthelmintics
B2b – coccidiostats, including nitroimidazoles B2c – carbamates and pyrethroids
B2d – tranquilizers
B2e – nonsteroidal anti-inflammatory drugs (AINS)
B2f – other substances exerting pharmacological activity B3 – Other substances and agents contaminating the environment B3a – organochlorine compounds, including PCBs
B3b – organophosphorus compounds B3c – chemical elements
B3d – mycotoxins B3e – dyes B3f – other
N.B: It should be kept in mind that the sum of the number of samples analyzed for one or more substances, belonging to the different groups of molecules (e.g., the sum of samples analyzed for category A and B substances), cannot be compared with the total number of samples taken.
The nonconformities
A total of 27 (or 0.1 % of the total samples taken) were non-compliant samples (20 taken in slaughterhouse and 7 in farm) for the presence of residues in 2020. Most of the noncompliances relate to exceeding maximum residue limits for antibiotic substances and corticosteroids.
In the table below, the details of the matrices found to be non-compliant can be seen.
In the last decade (2010-2020) we are witnessing a:
- Gradual decrease in the number of antibiotic noncompliances,
- Substantial constancy of the other substances contained in the authorized medicines
- Reappearance of noncompliance for banned substances.
Conclusions and actions following noncompliance
Of the 27 samples found to be noncompliant, several causes were recorded by authorities on the NSIS system following field investigations:
- Incidental contamination (1 sample)
- Unlawful treatment (5)
- Drug waiting time not met (1)
- Not ascertained (5)
- Other causes (8)
- Environmental contamination (2)
- Ongoing investigation (5)
From these nonconformities, subsequent corrective actions resulted; taking into account the fact that for each nonconforming sample, multiple actions may have been taken, it is not surprising that the number does not actually coincide with the number of nonconforming samples. In fact, the actions taken are summarized below:
- Administrative Consequences (19)
- Criminal offenses (7)
- Lot recalled from the market (4)
- Intensified controls in animal husbandry (19)
- Early warning notification (7)
- Community aid denial (11)
- Verification of records in the company (19)
- Follow-up surveys (10)
- Destruction of animals/products (7)
- Carcass/products declared unfit for human consumption (7)
- Restriction on the movement of animals (4)
- Intensified checks before release (7)
- Animals under seizure on the farm (5)
- Carcasses under seizure in slaughterhouse (4)
- Intensified controls at other farms (2)
- Further sampling on suspect (7)
- Other actions (3)
- Recommendations (1).
The Extraplane
The sampling activities
In case of special national/local needs, Extraplane targeted sampling activities may be carried out to search for groups of residues in the same matrices as in the Plan. In 2020, no national Extraplane activities were planned, but only and exclusively regional activities as summarized in the table below.
As for the Extraplane, in 2020:
- 1,555 samples taken
- 40,585 analytical determinations made
The samples taken and tested are:
As shown in the table above, most of the sampling was done on milk for antibacterial substances and aflatoxins.
The analytical activity
The parameters researched, were the same as in the “standard” Plan, and there were a total of 2 nonconformities that emerged, amounting to 0.1% of the total; specifically:
- 1 muscle sample taken at slaughterhouse positive for antibacterial substances (caused by illicit treatment)
- 1 honey sample taken at establishment positive for organophosphorus compounds (caused by accidental environmental contamination).
In both cases, the general corrective actions were:
- Products declared unfit for human consumption
- contestation of criminal offense
- destruction of the product.
The suspect
The sampling activities
Regarding, however, the Plan on Suspicion, this involves matrix sampling:
- In case there is reason to suspect the presence of any residues
- As a result of analytical nonconformities found in samples taken under the Plan and Extra Plan
- Subsequent to reports of suspicious diagnostic outcomes on histological testing
- As a result of samples in Special Emergency Slaughter Unit (MSU) cases positive for inhibiting substances
2020:
- 980 samples taken (largest number of samples performed on cattle)
- 39,480 analytical determinations made
Compared with the search for banned substances, there is a predominance of search for authorized substances, particularly antibiotics, cortisone and nonsteroidal anti-inflammatory drugs.
Nonconformities detected on the plan on Suspect
18 (or 1.8 percent of the total) noncompliant matrices in 2020 were sampled on suspicion, 14 of which involved cattle and the remaining 13 involved milk.
12 non-compliant samples out of 14 concerning cattle are reported to be due to the presence of antibiotic substances, following special emergency slaughtering.
Possible causes can be traced to the following list:
- Incidental contamination (4 samples)
- Unlawful treatment (3)
- Environmental contamination (1)
- Not ascertained (3)
- Other causes, i.e., causes not codified by EFSA (3)
- Drug withdrawal time not met (4)
Actions taken as a result of noncompliance:
- 13 Administrative consequences
- 8 Criminal offenses
- 5 Lot not released to the market
- 7 Intensified controls in animal husbandry
- 9 Community aid denial
- 15 Verification of in-house records
- 6 Follow-up surveys
- 13 Destruction of animals/products
- 4 Carcasses/products declared unfit for human consumption.
- 3 Intensified checks before release
- 9 Carcasses seized at slaughterhouse
- 1 Further sampling on suspect
- 1 Other actions
- 1 Recommendations
Timeline for the implementation of the NRP 2020
Monthly distribution of the Targeted Plan sampling activity.
In order to comply with the requirements of Decision 98/179/EC, namely that “NRP sampling activities should be carried out at varying intervals throughout the year to allow for uniform distribution of samples,” the 2020 targeted plan was distributed monthly.
From the graph below, which shows the distribution of PNR sampling activity, it suffered a physiological inflection in January, August and December as also noted in previous years, and in March/April due to the difficulty of sampling during the lockdown period caused by the Covid emergency.
Time of acceptance, sample processing, and data management
The procedure of the sampling plan, provides for the delivery of the matrix as soon as possible, that is, no later than 2 working days after sampling or within 4 if the weekend is taken into account.
Seventy-seven percent of the samples taken in 2020 in the 21 Italian regions were received by the reference laboratories within 2 days while 91 percent of the totals however within 4 days.
The technical time for issuing the test report (PDR) should be respectively:
- no more than 10 working days (14 actual days) for the search for category A substances and in the case of precautionary seizure;
- not exceeding 30 working days (42 actual days) for substances in category B.
Table 30 and Chart 13 show the percentage of analyses reported within the timeframe of the plan (from delivery of the sample to the analytical laboratory to issuance of the test report), broken down by Region/A.P. and substance categories.
In 2020, if all samples processed and their analytical parameters are taken into account, 73 percent of samples were reported within 14 days, while 88 percent were reported within 42 days; these delays, were the subject of critical observation by the European Commission during the audit that took place in 2018.
In order to facilitate annual reporting, it has been arranged that data on samples taken, should be uploaded to the NSIS/PNR portal every bimonthly. In 2020, the average of 90% of the samples, were recorded correctly meeting the expected timeline. Although this may seem like a positive figure, about one-third of the regions are below this threshold.
A focus on antibiotics
The NRP, therefore, turns out to be an effective tool to monitor the presence of veterinary drug residues and consequently counteract the phenomenon of antibiotic resistance by indirectly assessing therefore:
- The correct use of the drug in breeding,
- adherence to suspension time
- The proper recording of processing and any unlawful or improper use.
In 2020, under the Targeted Plan, out of a total of 30,029 total samples analyzed for all scheduled substances and matrices, 8,677 samples (about 29 percent) were analyzed for at least one antibiotic substance.
Out of the 8,677 samples tested for antibiotic substances, 12 non-compliant samples were found, with 13 non-compliant outcomes, as shown in the table below (Table 34):
The percentage of noncompliance recorded in 2020 for antibiotics (0.14 percent), compared to the total number of samples analyzed for this category of substances, stands at values that remain constant over the years.
Critical issues in the implementation of NRP 2020 and considerations for future developments
- The year 2020 was the third year of activity reporting with the new data collection system, through the format of Standard Sample Description ver.2.0 (SSD2), adopted to fulfill the information debt to the European Commission and EFSA.
- In terms of noncompliance and compliance rates, the situation is comparable with that of previous years.
- The NRP 2020 activity was marked by the difficulties encountered on the ground due to the pandemic emergency that necessarily affected the regional health systems responsible for carrying out NRP sampling. The significant pressure on the NHS, in addition to the issues related to the national lockdown experienced in the spring of 2020, was a cause of hindrance in carrying out the sampling plan and sample analysis, as the same health services personnel, when not affected by the outbreak, were assigned to other emergency activities, such as contact tracing or swab analysis.
- These difficulties have, for the first time in the history of the NRP, not allowed the achievement of EU targets for some animal species, along with the failure to achieve national planning targets for several animal species.
- Although some national and EU targets in terms of number of samples were not met, there was still an increase in the number of analytical determinations compared to previous years, a sign of the increasing availability of investigation at Italian laboratories.
- Also for 2020, several critical issues are highlighted regarding the quality of the reported data, particularly analytical data, for which errors were found that in some cases could jeopardize transmission to EFSA. On this issue, the effort, initiated in past years, to define with the National Reference Laboratories more stringent IT rules that would block the entry of inconsistent data should be continued.
- We continue to see the use of generic headings such as “Other” or “Unknown,” while more specific headings should be used, including for what concerns groups of molecules.
- Regarding the timing of implementation, in addition to the usual declines found in the first month of plan implementation and in August and December, the decrease in activity found in March and April 2020, corresponding to the first months of national lockdown, is evident.
- The failure of IIZZSS to upload data into the NSIS system for sampling animals from other member states sent directly to Italian slaughter plants is also reported for 2020.
Non-compliant samples – Targeted plan
Non-conforming samples -Extraplane
Non-conforming samples – Suspicion
Veterinarian at the University of Padova, specializing in the inspection of food of animal origin and specializing in breeding, hygiene, pathology of aquatic species and control of derived products. After various experiences as quality manager in the collective catering sector and management of an accredited laboratory for agro-food analysis, he is a manager at the Veterinary Service of Food Hygiene (SVIA) of ULSS 7 Pedemontana (Veneto)
