Dec 28, 2011

25% of city eateries still to apply for FDA licence

AS the city preps up to celebrate the New Year in a few days from now, about 25 per cent of restaurant owners are yet to submit forms to procure licences from the Food and Drug Administration (FDA). In this case, those restaurants would be declared illegal, said Assistant Commissioner of FDA Chandrakant Salunke. 

According to the amended Food Safety and Standards Act (FSSA) of 2006, it is mandatory for all food manufacturers, including small eateries, to register or renew their licence from the FDA. December 31 is the last date to submit applications. 

Salunke said, "Those who have submitted forms but are yet to get licences can run their establishments. Eatery owners who do not submit applications in time will be declared illegal. So far only 75 per cent restaurant owners in the city have applied for the licence."

Ganesh Shetty, president of Restaurants and Hoteliers Association (RHA), said 150 restaurant owners took forms from the RHA office yesterday.

Food Safety Becoming More Critical to C-stores

NATIONAL REPORT -- The Food Safety Modernization Act (FSMA), which was signed into law by President Obama on Jan. 4, 2011, has already begun to leave its mark. However, convenience store operators can expect it to become much more prevalent in 2012.
The law was signed in an attempt to protect the 48 million Americans who get sick from foodborne diseases annually. According to the U.S. government, 128,000 of those people are hospitalized following exposure and 3,000 die annually.
Although not every guideline within the FSMA affect c-store owners, several aspects of the law could matter at your store. Here's a look at some of those mandates:
  • Mandatory controls for food facilities: Food facilities are required to implement a written preventative controls plan. This involves evaluating the hazards that could affect food safety; specifying what preventative steps, or controls will be put into place to prevent the hazards; specifying how the facility will monitor these controls to ensure they are working; maintaining records of the monitoring; specifying what actions the facility will take to correct problems that arise.
  • Mandatory produce safety standards: The U.S. Food and Drug Administration (FDA) must establish science-based, minimum standards for the safe production and harvesting of fruits vegetables.
  • Mandated inspection frequency: The FMSA establishes a mandated inspection frequency, based on risk, for food facilities.
  • Records access: The FDA will have access to records, including food safety plans. Other aspects of the law dramatically increase your responsibility if you import food. For the first time, importers must verify that foreign suppliers have adequate preventative controls to ensure the food that is produced is safe. The FDA can deny entry into the United States any foreign food where the government agency is denied access by the country in which the facility is located.
In addition, FSMA give the FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so by the agency. The FDA can also suspend the registration of a facility if it determines that the food poses a reasonable probability of serious adverse health consequences.

Food Recall – Effective tool for ensuring food safety and FSS Act, 2006

While Food Recall is a relatively new concept in India, with the FSS Act, 2006, focussing on this vital aspect, awareness is growing and companies are looking at it as a vital link in the supply chain.

Indian companies are slowly realising that at times the product they have released in the market, needs to be recalled. And this can be minimised if the company’s recall system is well planned, implemented and understood by those who are involved in core activities of sourcing, manufacturing and distribution functions.

With the kind of emphasis, which is being given to food safety nowadays, consumers are also very much aware and at the same time concerned about the safety of the product they consume.

Section 28 of Food Safety and Standards Act, 2006, of Government of India emphasises the need for product recall. This states
If a food business operator considers or has reasons to believe that a food which he has processed, manufactured or distributed is not in compliance with this Act, or the rules or regulations, made thereunder, he shall immediately initiate the procedures to withdraw, the food in question from the market and consumers indicating reasons for its withdrawal and inform the competent authorities thereof.
Every food business operator shall follow such conditions and guidelines relating to food recall procedures as the Food Authority may specify by regulations.

In the past, in order to strengthen food safety, the FSSAI had released the draft regulation known as Food Authority’s Food Recall Procedures Regulations, 2009, which shall come into force from date of its notification in the official gazette.

Salient features of yet-to-be adopted regulations:
Objective

● To guide food business operators on how to carry out a food recall through an efficient, rapid identification as well as removal of unsafe food and food that violate the Act and Rules & Regulations made thereunder from the distribution chain and informing consumers (where necessary) of the presence of potentially hazardous food in the market and ensure that unsafe food are contained and destroyed or rendered safe;
● To guide food business operators on how to establish a written recall plan for carrying out food recall in case the food does not meet the requirements of the hygiene, safety and quality of food and to protect the health of consumers; and
● To establish a follow-up action / post-recall report in order to ensure the
effectiveness of the recall and prevent a recurrence.

Scope 
● These regulations apply to the recall of food that presents a threat to the public      health or whose quality does not conform to the Act and Rules & Regulations made thereunder.
● All food businesses engaged in the wholesale supply, manufacture or importation of food regulated by Food Authority must have an up-to-date recall plan except food retailers, unless they are also engaged in the wholesale supply, manufacture or importation of food.
● Food businesses within the food service sector such as restaurants, caterers and takeaways are exempted to have recall plan unless they are running multi-outlet food business chains having integrated manufacturing and distribution network.
● The food retailers and businesses within the food service sector which do not need a recall plan, shall remove recalled stock from shelves and return it to the manufacturer, importer or wholesaler and must ensure that food that is subject to a recall is separated and identified from other food until it is disposed of in accordance with the instructions provided as part of the recall plan.
● A recall plan must be available in written form and shall be made available to the state food authority / food authority on request.
● The food business operator is required to comply with the plan it has developed when it recalls food.
● In the case of alcoholic beverages the mandatory mentioning of warning “consumption of alcohol is injurious to health” may not be treated as unsafe unless the beverage is otherwise not containing any harmful and dangerous substance that may cause serious health problems or is unsafe to the consumer.
Recall Classification 



FSSA Guidelines: Steps in Developing Recall Procedures



A Typical Composition of Recall Team
(Example from other established systems adopted internationally)

(Ensure that all functions are covered if various departments do not exist in your organisation)

Contents of food recall notifications 
● Name of the food business operator recalling the food.
● Name of the food, brand name, pack size, batch & code number, date of manufacture, used by date or best before date.
● The contamination / violation in the food / reason for recall.
● The “do not consume message if the food is unsafe.”
● Health warning and action.
● The places / outlets where the food is found.
● The action to be taken by the consumer.
● A contact number for queries.

The recalling food business operator shall respond to each query from the state food authority / food authority within 24 hours of the receipt of the query.

Contents of recall status report 
● Number of downstream food business operators or individuals notified, and date and method of notification;
● Number of food business operator responding to the notification and quantity of the particular food in their possession;
● Number of food business operator or individuals not responding to the notification and quantity of food dispatched to them. (if needed, the identity of non-responding food business operator may be requested by the state food authority / food authority);
● Quantity of recalled food and result of investigation;
● Proposed method of disposal or otherwise of recalled stock with records of destruction;
● Anticipated time limit for completion of the recall.

Dealing with the recovered food  
● The recalling food business operator shall store the recovered food in an area which is separated from any other food and is identified by a label plate with prominently written Recalled Product.
● The recalling food business operator shall maintain accurate records of the recovered food and their lot no. / batch code, pack size, brand name, date of manufacture, best before date etc. Proper recording system shall be available to ensure that all the foods are retrieved and their details recorded.
● The recalling food business operator may correct or reprocess the recovered food if appropriate in consultation with state food authority and ensure that it is fit and safe for human consumption before release to the market.
● In all other cases, the recalling food business operator will ensure appropriate destruction of such food in consultation with / presence of the state food authority representative.
● A complete record of the disposal of such product shall be maintained.

Post-recall report  
● The recalling food business operator shall submit post-recall report after the completion of the recall to assess the effectiveness of the recall.
● The effectiveness of a recall shall be assessed on the basis of the quantity / amount of food returned as a proportion of the quantity / amount of food that left the recalling food business operator while taking into account the retail turnover of the food.
● In addition to assessing the effectiveness of a recall, it is necessary to follow up by investigating the reason for the recall and taking action to prevent a recurrence of the problem.

Termination of a recall 
● The recalling food business operator may request termination of its recall by submitting a written request to the state food authority / food authority along with latest recall status report / post-recall report stating that the recall was effective.
● A recall may be terminated when the state food authority / food authority determines that all reasonable efforts have been made and it is reasonable to assume that the food subject to the recall has been removed and proper disposition or correction has been made.
● Written notification to the effect that a recall is terminated will be issued by the state food authority / food authority to the recalling food business operator within two weeks of the request submitted by the recalling food business operator.
● In case of unsatisfactory reports, the state food authority / food authority may consider further action like stepped-up inspection, seizure or any other legal action, against the recalling food business operator.

(The writer is food safety and system expert and consultant. He can be contacted at udai.saxena@gmail.com)

Ex-health secy K Chandramouli likely to take charge as FSSAI chief in January


Food Safety and Standards Authority of India (FSSAI), apex regulatory body for the food and beverage industry, is likely to get its new chairperson by the first week of January. A source informed  that K Chandramouli's appointment as head of the Authority has been cleared by the PMO's Appointments Committee of Cabinet (ACC).

The source further informed that Chandramouli emerged as a clear choice from among all the contenders which included R K Srivastava, ex-director-general of health services, and K Sujatha Rao, former health secretary. All the three have been among those being considered for the post since last September.

Chandramouli, who would be replacing P I Suvrathan, who superannuated in September this year, was the Uttar Pradesh cadre IAS officer of 1975 batch and retired this October as union health secretary under the ministry of health and family welfare. He functioned in that post December 2010 onwards, prior to that he worked as secretary, AIDS control, in the same ministry.

Chandramouli's appointment is a good decision for the FSSAI but only that he comes from health industry background and may have to study the intricacies of the food industry deeply, the source said.

However, his stint with the labour and employment ministry would provide him the required aid in managing the working of the FSSAI, which was yet in its infancy stage, added the source.

CEO V N Gaur was given the additional charge of the chairperson after Suvrathan's retirement.