B8990 - TOSSICOLOGIA DEI RESIDUI NEGLI ALIMENTI DI ORIGINE ANIMALE

Learning outcomes

By the end of the course, students will have acquired a general understanding of pharmacokinetics and pharmacotoxicology as they relate to the persistence of residues in animal products, as well as knowledge of the main toxicological risks posed by the presence of drug residues and substances toxic to humans. Specifically, students will be able to: - understand and evaluate the main pharmacokinetic parameters; - draft an experimental protocol for determining the withdrawal period; - understand the basic principles, both theoretical and practical, of the analytical screening and confirmatory methods required by the National Residue Plan. This course is part of an integrated program whose ultimate goal is to enable students to acquire knowledge and skills regarding the safety of food of animal origin, covering both legislative and toxicological aspects. By the end of the course, students will be able to independently address issues and apply the knowledge acquired regarding the main mandatory and voluntary standards related to the safety, quality, traceability, and labeling of food of animal origin.

Course contents

Specific Course Prerequisites

To better understand the course content, it is recommended that students have prior knowledge of:

• physiology of livestock;
• animal nutrition and feeding;
• animal production;
• food microbiology;
• principles of applied statistics.

The course is part of the integrated program in “Safety of Food of Animal Origin,” taught by Prof. Teresa Gazzotti.

Specific Course Content

The course is organized into six integrated teaching modules and uses four key food chains (cow’s milk, beef, eggs, and aquaculture) as longitudinal case studies.

MODULE 1 – Fundamentals of Residue Toxicology (8 hours)Lectures (6 hours)

This module introduces the fundamental principles of residue toxicology and risk assessment, providing the conceptual tools necessary to interpret the presence of residues and contaminants in foods of animal origin.

The following topics will be covered:

• residues, contaminants, hazard, and risk;
• principles of toxicology and the dose-response relationship;
• NOAEL, LOAEL, Benchmark Dose (BMD);
• Acceptable Daily Intake (ADI);
• Acute Reference Dose (ARfD);
• principles of toxicological risk assessment.

Practical Activity (2 hours)

Case Study: Tetracyclines in Milk

Students will analyze a non-compliance issue related to tetracycline residues in a dairy supply chain, applying the principles of risk assessment and discussing possible management strategies.

MODULE 2 – Veterinary Drugs and Residues (8 hours)Theoretical Lectures (6 hours)

This module explores the behavior of veterinary drugs in food-producing animals and their role in residue formation.

The following topics will be covered:

• use of veterinary drugs in animal production;
• pharmacokinetics of residues (absorption, distribution, metabolism, and elimination);
• residue formation in various food matrices;
• withdrawal periods;
• maximum residue limits (MRLs);
• comparison between livestock and aquaculture production chains.

Practical Activity (2 hours)

Comparative Case Study: Cattle Farming and Aquaculture

Students will compare two different production chains, analyzing the behavior of veterinary drugs, the formation of residues, and the implications for food marketing.

MODULE 3 – Environmental and Supply-Chain Contaminants (8 hours)Theoretical Lectures (5 hours)

This module addresses the origin, transfer, and fate of the main environmental and supply-chain contaminants in animal production.

The following topics will be covered:

• bioaccumulation and biomagnification;
• heavy metals (mercury, lead, and cadmium);
• persistent organic pollutants (dioxins, PCBs, and PFAS);
• mycotoxins;
• pesticides;
• transfer of contaminants along the food supply chain.

Practical Activity (3 hours)

Three Case Studies

Through three different case studies (milk, aquaculture, and eggs), students will trace the path of contaminants from the environment to food, identifying their sources and proposing prevention and management strategies.

MODULE 4 – System of Official Controls and Management of Non-Compliance (5 hours)Theoretical Lecture (3 hours)

This module introduces the functioning of the European food safety system and official controls, with particular reference to the roles of the various parties involved in the prevention and management of non-compliance.

The following topics will be covered:

• principles of the European food safety system;
• the Hygiene Package as the general regulatory framework;
• the roles and responsibilities of Food Business Operators (FBOs), Competent Authorities, and official laboratories;
• the operational principles of Regulation (EU) 2019/6 regarding the management of veterinary medicinal products;
• the organization of official controls in accordance with Regulation (EU) 2017/625;
• the purpose and operation of the National Residue Plan (PNR);
• an introduction to the European Rapid Alert System RASFF.

Practical Activity (2 hours)

Audit and Management of a Nonconformity

Students will analyze a nonconformity report, interpret company documentation, simulate a document audit, and discuss the corrective and preventive actions to be proposed to the Competent Authority.

MODULE 5 – Analytical Methods for Residue Testing (6 hours)Theoretical Lectures (4 hours)

This module presents the analytical process leading from sampling to the interpretation of laboratory results, with particular attention to the significance of analytical data for technical and health-related decision-making.

The following topics will be covered:

• sampling and sample representativeness;
• screening and confirmatory methods;
• principles of the ELISA method;
• overview of chromatographic techniques;
• principles of LC-MS/MS;
• interpretation of LOD, LOQ, and measurement uncertainty.

Practical Activity (2 hours)

Interpretation of Test Reports

Students will analyze various analytical reports related to different food matrices, discussing the screening–confirmation process and evaluating sample compliance.

MODULE 6 – Risk Management in Animal Production (5 hours)Theoretical Lecture (3 hours)

This module concludes the training program by integrating the skills acquired in the previous modules and addressing risk management as a decision-making process.

The following topics will be covered:

• the difference between risk assessment and risk management;
• evidence-based decision making;
• management of uncertainty in animal production;
• quality systems as tools for prevention and continuous improvement;
• the One Health approach to managing the safety of animal production;
• analysis of the health, environmental, economic, and social consequences of decisions.

Practical Activity (2 hours)

Final Case Study: Cooperativa Appennino

Through a multidisciplinary simulation, students will manage a food crisis by integrating toxicological data, analytical results, company documentation, official controls, and quality systems, and by developing a risk management and continuous improvement plan.

Students will be asked to complete a Student Workbook, which will count toward their exam score.

 

Transversal Skills

The educational activities promote the development of:

• problem-solving skills;
• critical analysis of scientific data;
• interpretation of analytical and regulatory data;
• risk communication;
• teamwork;
• decision-making skills in complex professional contexts.

Readings/Bibliography

The course materials are available on the Virtual Platform (https://virtuale.unibo.it/).

Required Reading

• Gupta R.C. (Ed.), Veterinary Toxicology: Basic and Clinical Principles.
• Riviere J.E., Papich M.G., Veterinary Pharmacology and Therapeutics.
• Casarett & Doull’s Toxicology.

Further reading

• EFSA scientific opinions.
• EMA reports.
• Annual reports of the National Residue Plan.
• Annual RASFF reports.
• Current European regulations.

Teaching methods

The course consists of lectures and practical exercises.

The following methods will be used:

· lectures;

· case study discussions;

· problem-based learning;

· guided exercises;

· group work;

· interpretation of toxicological, regulatory, and analytical data;

· self-assessment quizzes.

The methodologies adopted promote active learning and the application of knowledge to real-world professional contexts.

With regard to safety in the learning environment, the course does not include activities in biological or chemical laboratories. Any seminar activities held at external facilities will be governed by the guidelines of the degree program.

Assessment methods

The exam for the integrated course consists of an oral exam covering both courses.

For this course, the oral exam consists of a discussion of at least three topics covered during the course and a case study assigned by the instructor.

Bonus point (1 additional point toward the final grade) will be awarded for completing the Student Book—which must be submitted at least 15 days before the exam date. Student Books submitted less than 15 days before the exam will not be evaluated.

 

Estimated duration: 20–30 minutes.

In grading the oral exam, the instructor refers to the following learning assessment scale:

• Preparation on a very limited number of topics covered in the course and analytical skills that emerge only with the instructor’s assistance → 18–22;
• Preparation on a limited number of topics covered in the course and ability to analyze independently only on purely procedural matters → 23–26;
• Preparation on a wide range of topics covered in the course, ability to make independent critical analysis choices, and mastery of specific terminology → 27–29;
• Substantially comprehensive preparation on the topics covered in the course, ability to make independent critical analysis and connection choices, full mastery of specific terminology, and ability to argue a point → 30–30L.

The oral exam grade is communicated at the end of the interview.

The exam is considered passed with a minimum score of 18/30.

The instructor responsible for recording the final grade for the Integrated Course is Prof. Teresa Gazzotti.

 

A student may reject a grade once, by notifying the instructor responsible for recording the grade within 5 business days.

The instructor responsible for recording the grade is the instructor in charge of the course.

Students with learning disabilities or temporary or permanent disabilities are encouraged to contact the relevant university office: https://site.unibo.it/studenti-con-disabilita-e-dsa/it/per-studenti

Teaching tools

· PowerPoint presentations.

· Real-world case studies.

· EFSA reports.

· EMA reports.

· National Residue Plan reports.

· RASFF notifications.

· Anonymized test reports.

· Educational quizzes.

· Materials available on Virtuale.

Generative AI can be used to support independent study, in-depth analysis, and self-assessment, provided that it is used critically and thoughtfully.

Office hours

See the website of Annalisa Zaccaroni