FVO reports – Import controls for plant health in Italy and Xylella fastidiosa crisis

In case you are still surprised about the Xylella fastidiosa outbreak in the Region Apulia, in the south of Italy, which between 2014 and 2015 nearly destroyed the Italian olives harvest, you should read the following Food and Veterinary Office’s reports (n. 2014-7327, Nov. 2014, 2015-7212, June 2015 and 2015-7580, Nov. 2015) and my former article about the topic, “Plant health: Xylella fastidiosa outbreak in Italy and damages to olive trees”.

The overall picture is still not encouraging after 2 years…

Plant health import controls

“This report (2015-7603) describes the outcome of an audit carried out in Italy from 8 to 17 September 2015. The objectives were to audit the capability and the performance of the official bodies responsible for import controls and the adequacy and effectiveness of import checks carried out for plant health purposes to ensure compliance with EU requirements.

Particular attention was paid to follow up on the action taken in Italy in response to the recommendations of previous reports. Overall, some progress has been made in Italy since the previous audit (2013). The planned (comprehensive) national computer-based manual of procedures has become operational recently. It has a significant potential to address a number of the weaknesses of the plant health import control system. Certain recommendations of the previous audits have now been satisfactorily addressed, and the actions planned in response to the remaining recommendations are ongoing, albeit with a delay.

Many of the shortcomings identified during the previous audit are still present, in particular, the shortage of resources, the lack of instructions and specific technical training to carry out meticulous plant health checks. In most of the regions visited, phytosanitary risks presented by the imported commodities are not taken into account and adequate inspection facilities, although available, are not used. Therefore, the current plant health import control system does not ensure that these controls are risk based and effective. This is reflected in the number of interceptions notified by Italy of imported plant consignments and of wood packaging material originating in all Third Countries which is low compared to the volume of trade.

Xylella fastidiosa (Nov. 2014 – follow up Feb. 2014)

This report (2014-7327) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy, from 18 to 25 November 2014, following an earlier audit in February 2014.

The objective of the audit was to evaluate the plant health situation and control measures applied for Xylella fastidiosa (Well and Raju), in particular, the implementation of Commission Implementing Decision 2014/497/EU of 23 July 2014.

The audit team found that: Extensive human and financial resources have been made available for research and containment of Xylella fastidiosa, and there is a good level of awareness about the problem. With one exception, none of the eradication measures required by Decision 2014/497/EU, have been carried out. The situation has deteriorated since the last audit and Xylella fastidiosa continues to spread rapidly. The current Italian policy for the Infected Zone is now containment of Xylella fastidiosa and measures aiming at full eradication of the pest are not carried out. The current controls do not ensure that host plants not fulfilling the requirements of the EU Decision remain in the Demarcated Area. All the existing garden centres located in the Demarcated Area have not been identified and, therefore are not officially controlled. There is a possibility that not all host plant species have been identified and pathogenicity tests for a range of genera (including Vitis and Citrus) have not been concluded.

Until the precise host range of Xylella fastidiosa is known, the movement restrictions in place (although applied to a wider range of species than required in the Decision) do not provide adequate security that no infected plants leave the area. The proposed intensive surveys in the Eradication Zone, Buffer Zone and Security Zone, will help in the early detection of Xylella fastidiosa and enable the implementation of rapid eradication. This strategy could also limit the natural spread of the insect vector to new areas. However, taking into account the high populations and the passive mobility of the insect vector (vehicles, wind), the protective function of the two zones is questionable. There is a significant risk of further spreading of Xylella fastidiosa outside the Demarcated Area.

Xylella fastidiosa (June 2015)

This report (2015-7212) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy from 8 to 19 June 2015. The objectives of the audit were to evaluate the plant health situation and control measures applied for Xylella fastidiosa in Italy and in particular, the implementation of Commission Implementing Decisions 2014/497/EU and 2015/789/EU.

The audit was carried out in addition to the planned FVO programme following a further significant and rapid spread of Xylella fastidiosa in Apulia in early spring 2015 and the declaration of a state of emergency by the Italian Council of Ministers of February 2015.

The authorities responsible for the official controls of Xylella fastidiosa have developed a plan for the implementation of national legislation and the EU Decisions, which provides a sound basis for the control of Xylella fastidiosa, including surveillance, agricultural measures to suppress the vectors, movement restrictions for plants, the eradication of new outbreaks and infected plants and communication with producers and stakeholders. The FVO team found no evidence at the time of the audit, of any critical technical, resource, or general legal constraints which would prevent the authorities from implementing these measures, especially since the declaration in February 2015 of a state of emergency for Xylella fastidiosa in the Apulia region.

However, it was found that many of these measures have only been partially implemented or not implemented at all. In particular, a total of only 111 trees have been destroyed in Apulia since the first confirmation of Xylella fastidiosa in 2013. In the specific case of the Oria outbreak, only seven of the 37 infected trees have been eradicated since the outbreak in March 2015. There are now 52 infected trees in that area. The existing programme of surveys is not effective to allow for the timely detection of new outbreaks or the accurate determination of the true extent of the spread of Xylella fastidiosa.

The measures implemented so far have clearly not been sufficient to prevent the further rapid spread of Xylella fastidiosa within the Demarcated Area and, in the absence of concerted action, and full implementation of the necessary measures and effective engagement with stakeholders, the further rapid onward expansion of the disease is inevitable.

Xylella fastidiosa (Nov. 2015)

This report (2015-7580) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy from 10 to 20 November 2015. The objective of the audit was to evaluate the situation and control measures applied for Xylella fastidiosa in Italy and in particular, the implementation of Commission Implementing Decision 2015/789/EU of 18 May 2015 setting out protective measures. The action taken to address the recommendations of the previous audit on this topic was also evaluated.

This was the fourth audit to Italy on this topic; it followed developments in the national measures for X. fastidiosa, including the adoption of an action plan, and a further significant and rapid spread of the disease. The audit found that there have been some positive developments since the previous audit on this topic in June 2015. An action plan, aimed at the eradication and containment of X. fastidiosa within the demarcated area, and supported by a revised legal basis and the payment of compensation for some of the losses arising from the removal of plants, was in place.

An annual survey for the presence of X. fastidiosa has been carried out, and no evidence of the presence of the disease outside of the demarcated area has been found. However, the limited number of sites monitored in the general territory reduces the reliability of the claimed lack of presence of X. fastidiosa on the territory. This is particularly so in the area of Puglia north of the surveillance zone, which is at the highest risk from the natural spread of the disease, but which was subject to no, or only minimal, inspections. Surveys have also been carried out in the demarcated area, however the level of visual inspections applied in the surveillance zone and buffer zone is very significantly below that required by Articles 8(2) and 6(7) of Decision 2015/789/EU. The existing programme of surveys still does not ensure the timely detection of new outbreaks or the accurate determination of the true extent of the spread of X. fastidiosa in the demarcated area.

Action is now being taken in response to findings of X. fastidiosa in the demarcated area. The felling programme, which is subject to a number of significant constraints, is ongoing, however there is still a very substantial number of infected plants and host plants within 100m radius of such plants to be removed, outside of the province of Lecce.

The limited removal of plants is not in compliance with Article 6(2) of Decision 2015/789/EU, which requires that such plants are immediately removed and destroyed. There is a similarly substantial number of infected plants in the containment zone, within a distance of 20km of the border of the Province of Lecce, which have also not been removed and destroyed immediately, as required by Article 7(2)(c) of the Decision. A significant number of the plants concerned are subject to ongoing legal appeals, however it is of real concern that so many infected plants, and plants at very high risk of infection remain in place, given the evident consequences for producers in the affected areas and the onward and rapid spread of the disease to new areas and new producers.

Unless effective eradication and containment measures are implemented, the further rapid spread of the disease throughout the region is inevitable.

FDA – Gluten Free Labelling Compliance Requirements Proposed Rule

The U.S. Food and Drug Administration released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods”, pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis
  • The manufacturer has adequately evaluated its process for any potential gluten cross-contact
  • Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18 (closing date February 2nd, 2016). To electronically submit comments to the docket, visit www.regulations.gov and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information: