Frequently Asked Questions
- What are the various arms of the Department of Fisheries in Kerala?
- Where is the head office of Matsyafed and who is the Registrar of Matsyafed?
- Who is the executive head of ADAK and where is the head office of ADAK?
- Who is the executive head of KFWFB and where is the head office?
- Who is the executive head of FIRMA and where is the head office?
- Who is the head of Marine Enforcement and where is the head office?
- Who is the head of NIFAM and where is this institute?
- How many fishing villages are present in the marine sector of Kerala?
- How many fishing villages are present in the inland sector of Kerala?
- Give the sector wise fishermen population of Kerala in 2003-04?
- What was the number of active fishermen in Kerala in the year 2003-04?
- What much percent of fishermen population is below poverty line?
- What are the districts in Kerala without coastline?
- What is the percentage of fisherfolk population having own houses?
- What are the National Fish Seed Farms of the Department of Fisheries?
- What are the fish seeds produced in the above fish seed farms?
- What is KRFDP?
- Does the Fisheries Department have a shrimp hatchery?
- What are Monoculture and Polyculture?
- What is meant by Composite fish Culture?
- Give the difference between cage culture and pen culture?
- What is a good size and shape for a carp pond?
- How deep should a carp pond be?
- What can be done to prevent heavy rains from flooding the pond and breaking the dam?
- What are the fishes suitable for farming in coldwater ?
- My pond suffered a disease outbreak 30 days after stocking the last crop. Please advise me how to prepare the pond for the next crop?
- What should be the optimum soil pH for shrimp culture?
- It is very difficult for us to discard the sludge away from the pond site as in our village all the area is filled with ponds, with out leaving much free space.Where to discard the sludge and is there any other option to reduce the sludge in the pond?
- What are the disinfectants found useful in reducing disease outbreaks from your study observation? Why are they effective in Nellore district only?
- Is the use of pesticide good or bad? If bad, do you suggest any alternative to disinfect the pond?
- What is the required water depth in culture ponds?
- Measuring pH using liquid pH indicators is not showing any minor fluctuations in pH. So how can this type of pH measurement be useful for the farmers?
- How to reduce pH in saline waters when there is no color/bloom in the water?
- Why does pH change suddenly on daily basis?
- Why does pH rise suddenly when poultry manure is applied to get a bloom? How to control pH in such a situation?
- How to reduce ammonia and what level kills shrimps at high pH values?
- During rains the water temperature reduces and shrimps come to the sides. Why? And how to avoid it?
- Is it good to use some fishes in shrimp ponds? If yes why? Which species and how many numbers should be introduced?
- For water exchange, which time of the day is suitable?
- Why is there a sudden collapse of bloom after 30 days of culture?
- How to control blue-green algae (filamentous/slime forming species) in low saline waters?
- How to control filamentous algae?
- How to control benthic algae?
- What is the reason for excessive algal bloom in the pond?
- Since 1994, farmers have observed good crop in lower salinity area compared with higher salinity area. Why?
- PL from the same hatchery tank were stocked in the same nursery pond and then distributed to 5 grow-out ponds. At the end of the crop. 3 ponds faced disease outbreaks and 2 ponds were harvested without disease problems. Why?
- What are the symptoms of HPV? In which area has it been observed during the MPEDA/NACA study?
- What is LSS ? How can it be prevented from the beginning?
- What is vibriosis? What are the clinical signs? How to prevent the disease?
- Can antibiotics control the white spot disease outbreaks?
- In shrimp nurseries, cutting insects (Notonecta sp) are present and kill the PL. How to control them?
- After three months of culture there are a lot of shrimp that are weak and unhealthy with thin bodies and that are growing slowly, why?
- Preparation of water colour before releasing the PL is difficult, the pond water colour only turned green for 2-3 days and after that the water became clear. How can we get an adequate algal bloom in the pond?
- If I can’t make the water colour naturally, it is ok to use artificial water colourants?
- During heavy rain, is it necessary to lime the bank of the pond?
- If it is raining, does it matter if we postpone the feeding time or not?
- I am farming P. monodon and for the first 80 days, the shrimp have grown well but when I changed the pellet to a larger size (No.5), the shrimp started to grow slowly. What is the cause of this problem?
- I have a shrimp farm and the water becomes turbid from soil, particularly after in newly-filled ponds after it rains. It prevents the shrimp from eating, what can I do?
- I stocked my shrimp in August – September and cultured for 70 days. During this time there was a lot of rain and the shrimp reduced their rate of food consumption by more than 50 %. Afterwards the shrimp were weak and thin, and even though the climate returned to normal the shrimp did not increase eating again. At harvest time my production was 20-30 % lower than estimated in every pond. I do not know where I lost the shrimp and I didn’t see any shrimp die during culture period. What happened?
1. What are the various arms of the Department of Fisheries in Kerala?
Kerala State Co-operative Federation for Fisheries Development Ltd (Matsyafed), Agency for the Development of Aquaculture in Kerala (ADAK), Kerala Fishermen Welfare Fund Board (KFWFB), Kerala State Fisheries Resource Management Society (FIRMA), Marine Enforcement & Vigilance and National Institute Fisheries Administration (NIFAM) are the various arms of the Department of Fisheries.
2. Where is the head office of Matsyafed and who is the Registrar of Matsyafed?
The head office is at Kuravankonam, Kowdiar P.O., Thiruvananthapuram, Kerala. Director of Fisheries is the Registrar of Matsyafed.
3. Who is the executive head of ADAK and where is the head office of ADAK?
Executive Director is the head. The head office is at Vazhuthakkadu, Thiruvananthapuram.
4. Who is the executive head of KFWFB and where is the head office?
Commissioner is the executive head and the head office is at Thrissur.
5. Who is the executive head of FIRMA and where is the head office?
Executive Director is the head and the head office is at Thiruvananthapuram.
6. Who is the head of Marine Enforcement and where is the head office?
Superintendent of Police is the Head and the head office is at Thiruvananthapuram.
7. Who is the head of NIFAM and where is this institute?
Director, NIFAM is the head and the institute is at Ernakulam
8. How many fishing villages are present in the marine sector of Kerala?
222 fishing villages
9. How many fishing villages are present in the inland sector of Kerala?
113 fishing villages.
10. Give the sector wise fishermen population of Kerala in 2003-04?
The population was 2.51 lakhs in the inland sector and 8.44 lakhs in the marine sector. The total population was 10.95 lakhs.
11. What was the number of active fishermen in Kerala in the year 2003-04?
The number of active fishermen was 1.79 lakhs and 0.41 lakh in the inland sector.
12. What much percent of fishermen population is below poverty line?
61% of fishermen population is below poverty line.
13. What are the districts in Kerala without coastline?
Palakkad, Pathanamthitta, Wayanad and Idukki are the districts without coastline.
14. What is the percentage of fisherfolk population having own houses?
89% of fisher folk population have own houses.
15. What are the National Fish Seed Farms of the Department of Fisheries?
Fisheries Department has two National Fish Seed Farms (NFSF) – one at Malampuzha in Palakkad District and the other at Kaviyoor near Thiruvalla in Pathanamthitta District.
16. What are the fish seeds produced in the above fish seed farms?
Fish seeds are produced through induced breeding using pituitary extract or ovaprim. Fingerlings of carp fishes such as catla, rohu, mrigal, labeo, cyprinus and grass carp are distributed from these fish seed farms.
17. What is KRFDP?
It is the short form of Kerala Reservoir Fisheries Development Project.
18. Does the Fisheries Department have a shrimp hatchery?
Yes. The Department has a shrimp hatchery in the name Regional Shrimp Hatchery at Azhikode in Thrissur District producing disease free quality shrimp post larvae. There is also one shrimp hatchery at Kollam under Brackish Water Fish Farmers Development Agencies.
19. What are Monoculture and Polyculture?
The fish culture system in which only a single species is stocked is monoculture where as in a Polyculture system two or more fish species are stocked together.
20. What is meant by Composite fish Culture?
In a pond, the surface is occupied by floating organisms like plankton, the column region with live and dead organic matter sunk from the surface and the bottom with detritus or dead organic matter. The different trophic levels of a pond can be utilized for increasing the profitability of fish culture. Composite fish culture is a polyculture system in which compatible fishes of different species having different feeding habits are selected and grown in the pond to exploit all types of food available in the different regions of the pond for maximizing fish production. The aquatic vegetation, plankton, decayed organisms and other debris available in the surface, middle and bottom water layers are utilized as feed by the stocked surface, middle and bottom dwelling fishes. Catla, rohu, mrigal, cyprinus, grass carp and silver carp are highly considerable for composite fish culture.
21. Give the difference between cage culture and pen culture?
Cage is a fixed/floating structure made of wooden frame and nylon netting and installed in running or stable water bodies.
Pen is a large closed enclosure in reservoirs, lakes or in sea where floods/cyclones do not cause harm. Pens are erected by split bamboo, wooden, nylon netting or such other structures.
22. What is a good size and shape for a carp pond?
After selection of the site for the pond with a good water supply, you can start digging. The size and shape of the pond should range between 0.1 hectare to 0.8 hectares in rectangular shape will be a good size pond. In case of running water unit the size is 30X1.5X1.2m.
23. How deep should a carp pond be?
The water should be 2 mtr deep and one end and 1 ½ meter deep at the shallow end.
24. What can be done to prevent heavy rains from flooding the pond and breaking the dam?
If the pond is built in a place where it collects too much water in times of heavy rains, a wide ditch should be dug at one side of the Bank to carry away the extra water, when it rains hard, the extra water will run through the side spillway rather than break the sides of the pond.
25. What are the fishes suitable for farming in coldwater
Mirror carp/Rohu/Silver carp/ Catla catla/Mirgla etc for warm district, trout for Coldwater district
26. My pond suffered a disease outbreak 30 days after stocking the last crop. Please advise me how to prepare the pond for the next crop?
Prepare the pond normally by removing the black soil (sludge), which has a bad smell. Dispose this removed sludge away from the pond site. Maintain the water reservoir and culture the plankton in reservoir first and then trfer the water to grow-out ponds. Avoid clear water at stocking by adding more fertilizer to get a green color. Maintain pH and alkalinity by applying the required quantity of lime. This entire process may require 30 days before stocking. So plan the pond preparation accordingly.
27. What should be the optimum soil pH for shrimp culture?
It should be above 6. However, farmers should check the water pH and try to maintain it in the range of 7.5-8.5 by using lime, because it is difficult to completely rectify the soil pH problems.
28. It is very difficult for us to discard the sludge away from the pond site as in our village all the area is filled with ponds, with out leaving much free space. Where to discard the sludge and is there any other option to reduce the sludge in the pond?
Most preferred practice is to discard the sludge away from the pond site. If the black soil is disposed off on the bunds of the pond then it may seep back to the pond during rain and again create a bad pond bottom condition. Sludge may be disposed off in a trench dug along the bund so that it does not seep back in to the pond, which is better than not removing it at all. In case it cannot be removed, ploughing several times on wet soil can reduce the organic matter, which will be a more time consuming activity.
29. What are the disinfectants found useful in reducing disease outbreaks from your study observation? Why are they effective in Nellore district only?
Iodine compounds were found to be commonly used as disinfectant in Nellore district. The compounds were found to be more effective if used during pond preparation. They were not commonly used in West Godavari district since it may not be a cost effective practice to use such compounds in low input farms.
30. Is the use of pesticide good or bad? If bad, do you suggest any alternative to disinfect the pond?
The use of pesticides is bad because they can accumulate in the environment as well as in the shrimps. Screening the water using water filters to prevent the carriers and storing the water for at least 7 days before pwnping to grow-out ponds is a. better option.
31. What is the required water depth in culture ponds?
The optimum, depth should be 1.2 meter. There should be a minimum depth of 0.8m in the shallowest part of the pond.
32. Measuring pH using liquid pH indicators is not showing any minor fluctuations in pH. So how can this type of pH measurement be useful for the farmers?
The purpose of using liquid pH indicators is to look only at the pattern or trend on how pH changes. Greater fluctuations ofpH can be easily noted by farmers during critical periods using simple kits. Farmers can afford to have a simple liquid pH indicator, as its price is below Rs 100 and 200 tests can be carried out.
33. How to reduce pH in saline waters when there is no color/bloom in the water?
Exchanging the water by 10-20 % may introduce phytoplankton before applying fertilizer and some agricultural lime. This approach will lead to the bloom. Also one can try using 10 to 15 Kgs of rice bran or wheat bran in one ton of water (pond), stirred frequently at an interval of 2 to 3 hrs and fermented for seven days to develop acidic bacteria. The supernatant acidic water should be applied to the pond water every 7 days till the pH gets reduced to normal level.
34. Why does pH change suddenly on daily basis?
Excessive algal blooms or low alkalinity.
35. Why does pH rise suddenly when poultry manure is applied to get a bloom? How to control pH in such a situation?
Too much manure in a single dose can raise the pH suddenly. Reduced quantity of manure applied in 2-4 split dosages and subsequent addition of some water into the pond can control this situation.
36. How to reduce ammonia and what level kills shrimps at high pH values?
Again, the most cost effective way to dilute any toxic condition, especially ammonia in the pond is to exchange some water. This will also reduce the water pH at the same time by diluting the bloom. The level of total ammonia nitrogen should not be higher than 1 ppm at pH value of 8.5.
37. During rains the water temperature reduces and shrimps come to the sides. Why? And how to avoid it?
The problem is caused by the cloudy sky that leads to reduced oxygen levels in the pond water. The feed consumption by shrimp gets reduced due to lower temperature. Therefore, feed quantity should be reduced and water exchange should be done if the water is too green in color.
38. Is it good to use some fishes in shrimp ponds? If yes why? Which species and how many numbers should be introduced?
Fish can be used in later stages of culture (after 60 days) for feeding on the plankton and benthic algae. In Thailand, 3,000-5,000 fry (1-2 cm.) of Tilapia are stocked in 1 ha. If the fish are big, then they can be stocked in cages. Some species like sea bass can eat the dead shrimp in the pond, which may help in reducing the trmission of virus from dead to live shrimp by avoiding cannibalism.
39. For water exchange, which time of the day is suitable?
Time does not make much difference. If can be done at any time as convenient to the farmer.
40. Why is there a sudden collapse of bloom after 30 days of culture?
For a healthy bloom to be maintained, it requires nutrients, carbon dioxide and sunlight. After around 30 days of culture the bloom develops heavily due to the availability of all three components. Due to heavy bloom the sunlight is prevented from penetrating the lower column of water thus leading to oxygen deficiency and death of plankton present in the lower column of water. This condition leads to collapse of the bloom.
41. How to control blue-green algae (filamentous/slime forming species) in low saline waters?
Water exchange is the most cost effective method. Incases where water exchange is not possible, aeration should be stopped during the strong sunlight period. This will allow the plankton to float on the surface where it will get pushed to the pond corner by the wind. The algae can be removed, or an algicide may be used in that corner of the pond to kill the algae. This is a low cost treatment method and safe for the shrimp since the chemical will be applied only to a small area. Repetition of this treatment may be necessary if the algae persists.
42. How to control filamentous algae?
In resen-oirs, the pliytoplankton bloom should be developed initially before shifting it to the grow-out ponds. Avoid using disinfecting agents in both reservoir and grow-out ponds.
43. How to control benthic algae?
Initially culture the plankton in a reser\>oir and then shift the bloomed water to grow-out ponds. Avoid clear water at stocking by adding fertilizer as required. Even after these measures if the benthic algae develops then drag a heavy iron chain along pond bottom to dislodge the algae from the soil surface and then remove the floating benthic algae using a hand net.
44. What is the reason for excessive algal bloom in the pond?
Mainly because of higher nutrient levels in the pond and less water exchange.
45. Since 1994, farmers have observed good crop in lower salinity area compared with higher salinity area. Why?
In ponds with lower salinity water, it is easier to control the water quality leading to less stress to the shrimp.
46. PL from the same hatchery tank were stocked in the same nursery pond and then distributed to 5 grow-out ponds. At the end of the crop. 3 ponds faced disease outbreaks and 2 ponds were harvested without disease problems. Why?
Disease outbreak not only depends on the seed quality but also on the individual pond management practices. Infected shrimp may not die at the same time in all the ponds. There may be a possibility that the 2 ponds with goodharvests might have been managed better, leading to reduced stressed conditions in the pond.
47. What are the symptoms of HPV? In which area has it been observed during the MPEDA/NACA study?
HPV stands for Hepatopancreatic Parvo-like virus, which can damage the hepatopancreas of shrimp, causing slow growth or stunting (similar to MBV). The study found the vims in both areas but at a very low prevalence when compared with white spot disease. HPV should not cause any serious problem in grow-out, if the ponds are well managed.
48. What is LSS ? How can it be prevented from the beginning?
This is "loose shell syndrome" and is usually caused by chronic bacterial infection. The primary causes of this infection are toxic conditions at the pond bottom. This is mainly related to clear water with benthic or filamentous algae. Overfeeding and high organic matter in the soil can also cause bad pond conditions and lead to the infection. To reduce the risk of this problem, pond bottom sludge should be removed during pond preparation. Maintaining green color water as well as better feed management to prevent benthic algae and pond bottom deterioration can also reduce the risk.
49. What is vibriosis? What are the clinical signs? How to prevent the disease?
Vibriosis is an infectious disease caused by Vibrio bacteria. The acute infection usually occurs when shrimps are one month old. Therefore, sometimes the farmers call it as one-month mortality syndrome. In higher salinity areas, the severity of this problem is usually greater and is caused by luminous species of bacteria. In this case the fanner may call the problem luminescent vibriosis. The clinical sign is not obvious. The sick shrimp is usually pale or darker color, with no feed in the gut. Sometime the problem is associated with soft shell. In later stages of the production cycle, the infection seems to be a chronic type. This is usually associated with loose shell syndrome. To prevent the infection, the pond should be prepared well and the green color must be maintained to prevent benthic algae. The pond bottom condition must be kept clean to prevent high organic matter accumulation.
50. Can antibiotics control the white spot disease outbreaks?
Viral diseases in shrimps cannot be treated by antibiotics.
51. In shrimp nurseries, cutting insects (Notonecta sp) are present and kill the PL. How to control them?
Spread palm oil over the water surface at the rate of 15- 20 litres/ha in the evening hours.
52. After three months of culture there are a lot of shrimp that are weak and unhealthy with thin bodies and that are growing slowly, why?
This problem is related to the shrimp consuming the available natural food supply and also to seasonal pond preparation to control the water colour around day 40-70 of culture. This problem is best avoided in the first place by preparing the pond well before stocking. If it occurs, try to remove the waste from the pond using pull chains, increase dissolve oxygen with aeration and try to control plankton bloom.
53. Preparation of water colour before releasing the PL is difficult, the pond water colour only turned green for 2-3 days and after that the water became clear. How can we get an adequate algal bloom in the pond?
Some of the possible causes of this problem are:
1. There is not enough fertilizer in the pond to support a phytoplankton bloom.
2. There is not enough sunlight on the pond.
3. There is not enough carbon dioxide in the pond.
In the first case you can fertilize the pond with cow-manure at a rate of 300-600 kg per ha and then another 30-60 kg per ha every 3-5 days. In some case can use ammonium nitrate fertilizer at a rate of 180-300 litres per ha with another 60-120 litres per ha every 2-3 days until the water colour improves in acid soil ponds. The second case is difficult to solve. In the third case, if the alkalinity is lower than 50 ppm you should add carbonate lime at the rate of 600-900 kg per ha every 3-5 days until alkalinity has reached more than 80 ppm.
54. If I can’t make the water colour naturally, it is ok to use artificial water colourants?
You can use artificial colourants but only for a short time. As a temporary solution apply around 6-12 bag per ha (it depends on the kind of colourant you are using, so make sure you check the manufacturers instructions carefully). The problem with using artificial colour is that, unlike a natural plankton bloom, there is no natural food for shrimp PL to feed on. It also cannot help to absorb ammonia and nitrite in water like plankton do. There is no substitute for a natural plankton bloom – it is necessary to prepare the shrimp pond to get the natural plankton.
55. During heavy rain, is it necessary to lime the bank of the pond?
It is necessary in the case of newly excavated ponds in areas where there are acid soils. This can usually be determined by observing an orange colour at the soil surface or in ponds where the alkalinity is less than 50 ppm and pH lower than 7.5. Under these conditions shrimp may be not able to molt or will have soft shell.
56. If it is raining, does it matter if we postpone the feeding time or not?
It depends on many factors including how heavy or frequent the rain, what kind of feed is used, the condition of the earthen pond and on water quality, particularly temperature and dissolved oxygen levels. The decision of whether or not to postpone feeding should be made considering the interaction of such factors. For example, if it rain for several days, then it is not necessary to postpone feeding but the quantity of food can be reduced by at least 20-30 %. If the water temperature is less than 23°C and it has rained in the afternoon, it can be postponed
57. I am farming P. monodon and for the first 80 days, the shrimp have grown well but when I changed the pellet to a larger size (No.5), the shrimp started to grow slowly. What is the cause of this problem?
Slow growth of shrimp can be caused by many factors, some of which may interact to affect growth. Farmers should consider recent events, the season, and conditions in the culture area. Some of the main factors are:
1. The condition of culture area, sediment deposits in the pond, water exchange frequency and water quality affect the shrimp and, if conditions are not good, cause them to reduce feeding or to stop eating altogether. The last factor is often important, as the pond bottom will start to become dirty after several months of culture, which can lead water quality to deteriorate.
2. High stocking density of PL can place pressure on the natural food supplies and environment in the pond. If the wastes have not been removed the pond may become polluted. If there is an excessive plankton bloom it may crash leading to a lack of oxygen and high ammonia in the pond as the bloom decomposes.
3. Changes in weather. Heavy rain or lack of sun for a long period, strong wind or monsoon can all cause the shrimp to stop eating. If there is a storm or monsoon in an area for 4-5 days, it will affect the growth of the shrimp and it may take them at least 7-10 days to recover.
4. Salinity. In the dry season water salinity sometime rises above 35 ppt. and the water cannot be exchanged. This can caused a fluctuation in water colour due to plankton crashes that can affect the shrimp. In the rainy season, the opposite may occur – low salinities may be a problem on farms using low salinity culture and this may also cause fluctuations in plankton populations.
5. Sampling weight of shrimp. At present there is usually 2-5 % of slow-growing shrimp (2-3 g) in ponds when culture period is 70-80 days, with a normal shrimp weighing about 10-15 g. In this case, we should not include the weight of these shrimp for calculation of the amount of food.
6. Low quality feed. Mostly the problem is the stability of feed pellets in water. This has not been commonly reported for some time, and it is not a serious problem for growth of shrimp.
58. I have a shrimp farm and the water becomes turbid from soil, particularly after in newly-filled ponds after it rains. It prevents the shrimp from eating, what can I do?
The colloid sediments are mostly a problem in newly excavated ponds and are made worse by rain after the sediment is washed in. They prevent sunlight from penetrating the water causing the plankton to die and leading to low oxygen levels and high ammonia concentrations. Farmers can avoid this problem by checking the water quality in the area before culture starts. It is possible to use a chemical to precipitate the fine sediments from the water column.
59. I stocked my shrimp in August – September and cultured for 70 days. During this time there was a lot of rain and the shrimp reduced their rate of food consumption by more than 50 %. Afterwards the shrimp were weak and thin, and even though the climate returned to normal the shrimp did not increase eating again. At harvest time my production was 20-30 % lower than estimated in every pond. I do not know where I lost the shrimp and I didn’t see any shrimp die during culture period. What happened?
This problem is common in every area and usually happens in the cold season when there isn’t any sunshine for several days or after several days of rain. These events cause the shrimp to eat less or stop altogether, which adversely affects their health, leading to disease and cannibalism. To prevent this problem the farmer should plan to culture shrimp in a more suitable season and also to harvest before the onset of the cold season. If this is not possible then during the culture period the farmer can use fresh food in place of pellets at night. The use of highly concentrated fish sauce to improve the smell of pellets and make them more attractive to the shrimp is one method that can be applied.
HACCP REGULATION FOR FISH AND FISHERY PRODUCTS
- What is HACCP Programme?
- What are Hazards and Risks?
- What are the main elements of HACCP?
- If a firm owns a seafood product but is not involved in it's processing, is the firm required to comply with the regulation?
- If a custom seafood processor, such as a contract manufacturer, processes fish owned by another entity is the custom processor required to comply with the regulation?
- How does the Seafood HACCP Regulation affect food service distributors? How does the regulation affect food service providers, hospitals, restaurants, and supermarkets?
- Is a firm that manufactures tuna sandwiches from canned tuna and distributes (sells) the product to sandwich vendors covered by the Seafood HACCP Regulation?
- If a firm sells their product intrastate to another processor, such as a warehouse, which distributes interstate, is the original firm covered?
- If a firm receives raw materials from outside the state and distributes the finished seafood product inside the state, is the firm subject to the HACCP regulation provisions for this product?
- Is a firm that stores imported frozen fish and distributes it to local fast food restaurants subject to the Seafood HACCP Regulation?
- Are public cold storage facilities exempt from the Seafood HACCP Regulation?
- Are cash and carry distributors covered by the Seafood HACCP Regulation?
- Since the regulation excludes retail, is a retail seafood market that processes some products (e.g. smoked fish) for the wholesale market covered?
- Must a retailer who imports products comply with the Seafood HACCP Regulation?
- Is an aquaculture producer a "processor" under the Seafood HACCP Regulation?
- Does holding lobsters in a lobster pound constitute "holding" as defined in the HACCP regulation?
- Which activities of a molluscan shellfish harvester are exempt from the requirements of the seafood HACCP regulation?
- Are molluscan shellfish wet storage facilities covered by the Seafood HACCP Regulation?
- Does the exemption for transportation include company trucks, contract haulers, drayage firms and middlemen i.e., firms that buy products from various harvesters at the dock, load product directly into their trucks, ice the product, and transport the product to market?
- Which activities of a harvest vessel are exempt from the regulation, under the definition of processing in 21 CFR, and which are not?
- Do vessels that process fish or fishery products on board (i.e. factory vessels) meet the definition of "processor" in the regulation?
- Fish are frozen, bagged, and boxed on a harvest vessel, are sold upon docking, and are unloaded into the buyer's dockside storage. Is the vessel a "processor" and, therefore, covered by the regulations?
- Since fishing vessels and carriers can have a marked influence on the safety of seafood products and yet are exempt from the Seafood HACCP Regulation, what can a processor do to minimize hazards that may be introduced at these points?
- When does temporary storage by a fisherman become "processing" as defined in the HACCP regulation?
- Does the Seafood HACCP Regulation replace the Current Good Manufacturing Practice Regulations (21 CFR 110) for fish and fishery products?
- Are all processors of raw fish species that have a parasite hazard required to control that hazard regardless of the intended use of the product (e.g., consumed raw, or cooked)?
- Is the hazard of parasites reasonably likely to occur in the processing of fish roe during which the eggs are removed from the scene and then processed in brine?
- With respect to changes that require processors to reassess their hazard analyses and HACCP plans, what do the terms "sources of raw material" and "consumers of finished product" refer to?
- What are the factors that make Clostridium botulinum a hazard that is reasonably likely to occur in a fishery product?
- Is Clostridium botulinum (C. bot.) a hazard in vacuum packaged raw seafood products that are stored and distributed refrigerated?
- Is the hazard of Paralytic Shellfish Poisoning (PSP) reasonably likely to occur in lobster?
- Is it true that no HACCP plans are required for raw shrimp and non-scombroid fresh fish?
- Must sulfites be identified as a significant hazard in a HACCP plan for shrimp?
- What would a typical HACCP plan look like for a wholesaler who buys product from a processor? For a retailer that buys directly from watermen? For watermen who sell directly to retailers? For a small seafood company?
- Can a single HACCP plan cover frozen, raw, breaded shrimp and frozen, parfried breaded shrimp?
- Must a firm have a separate HACCP plan for each different size shrimp it processes, when the only differences are the cooking times (e.g., the critical limits)?
- Does the seafood HACCP regulation apply to low acid canned seafood (LACF) or acidified seafood?
- Is control of the thawing process critical to ensuring the adequacy of the subsequent cook step?
- Must crab processors conduct heat penetration studies on their products and temperature distribution studies on their retorts, even if they have recording devices to show that they are cooking for a minimum of 4.5 minutes at 240° F?
- Is the cook step a CCP for the control of pathogens in crab?
- The recommendations in the Guide for cooling extremely large tuna (600-1200 pound fish) to 50° F within 6 hours of death are impractical. What alternatives do the industry have?
- Because of the slow development of histamine at low temperatures, the recommendations in the Guide for time/temperature critical limits during processing, seem unduly restrictive. Are there suitable alternatives?
- In industries like the canned tuna industry, where large quantities of fish (i.e., hundreds of tons) are received at a time from a single vessel, suppliers are usually quite stable, and there is a long history of histamine analysis with a low incidence of positive findings, the sample size for histamine analysis recommended in the Guide, seems excessive. Are there any alternatives?
- Does a subsequent processor need to ensure that a previous processor has actually controlled hazards in his product?
- In the case of fish that have a parasite hazard that are intended for raw consumption, is a label statement that the product should be cooked or frozen before consumption an acceptable control?
- What does the requirement for a yearly reassessment of the HACCP plan in Part 123.8(a)(1) mean?
- How should a processor measure the performance of a HACCP plan?
- How often should a firm test for sulfites in frozen shrimp they receive, if they have a certificate that states the shrimp is sulfite-free?
- The hazard analysis need not be written. Must the reassessment of a hazard analysis be written?
- How long must sanitation records be held if sanitation is not part of the HACCP plan?
- Must a seafood processor have a HACCP-trained individual do their hazard analysis, even if their product does not require a HACCP plan?
- Must the processor review sanitation records under the HACCP regulation?
- Are processors required to have a written sanitation standard operating procedure (SSOP)?
- Should a processor of cooked-ready-to-eat products monitor its processing water for residual chlorine?
- Can controls for time/temperature abuse during processing or storage be included in a processor's sanitation standard operating procedure rather than its HACCP plan?
- If the foreign processor does not have a formal HACCP plan but takes all steps necessary to assure safety of products, is this sufficient?
- How could ISO 9000 certification be useful to a foreign processing company in order to demonstrate compliance with the HACCP regulation?
- Has the EU accepted HACCP as a replacement for ISO when importing from companies outside the U.S.?
- Does the seafood HACCP regulation apply to imported low acid canned foods (LACF) or acidified foods?
- Must an importer have a HACCP plan for its own operation?
- Can the importer verification activities, i.e., performing affirmative steps, be conducted by the foreign processor?
- Is it required that an importer hire a third party to perform its verification activities?
- Does the importer need verification that Sanitation Standard Operating Procedures (SSOP) are being followed and monitored by a foreign processor?
- If an importer receives product from a country covered by a seafood HACCP MOU, does the importer need to maintain any HACCP verification documentation?
- Does a Memorandum of Understanding (MOU) signify that an acceptable HACCP program exists?
- Once an MOU is established with a new country, will those importers of that country's products, who are subject to detention without physical examination because their importer verification documents were inadequate, be automatically removed from the Import Alert?
- Can one product safety specification be used by several importers of the same product?
- Will importers be required to test entries against their product specifications?
- Is it necessary for importers to insist that their product specifications be signed by the foreign processor or that the foreign processors write a letter guaranteeing adherence to the specifications?
- Do product specifications need to address non-safety issues such as filth and decomposition?
- What should be the frequency of affirmative step procedures (i.e., How often should on-site audit visits be made or how often should a product be tested)?
- How many of the six affirmative steps found in the regulation must be conducted by importers?
- Do HACCP plans and all sanitation and HACCP monitoring records held by importers as part of their verification program need to be in English?
- Do importer verification records (i.e., affirmative action step documents) need to be originals? For instance, the original HACCP plans or monitoring records received by importers may have been in a foreign language, and the importer may have had them translated into English; or, for the sake of timeliness, the monitoring records, HACCP plans, guarantee letters and certificates may be sent via fax.
- If the importer chooses to visit the shipper or foreign manufacturer as a verification affirmative step, does the person visiting need to be HACCP certified?
- When a third party certificate is used to demonstrate the foreign processor's adherence to the HACCP rule, what documentation is necessary? Is the third party's audit report necessary?
- If a foreign processor has determined that there are no safety hazards in its product, should the importer maintain a copy of the processor's hazard analysis?
- If a foreign processor has an adequate HACCP program, sends the same product to two importers, and one performs adequate verification and one does not, which products will be placed on detention without physical examination?
- Does the seafood HACCP Regulation supersede the National Shellfish Sanitation Program (NSSP)?
- Is it necessary for a shellfish dealer who removes the tags from containers of molluscan shellfish during processing, to save each individual tag, or can the dealer save a tag from each lot and the invoice to demonstrate how much of the product was purchased and from whom? Currently this practice is allowed by the NSSP.
- Does the Seafood HACCP Regulation permit the heat treatment of molluscan shellfish harvested from unapproved growing waters?
- Are there any specific cooking temperatures required for a fishery product to be considered to be "fully cooked" or "ready-to-eat"?
- Will there be a HACCP logo for products?
- What percentage of seafood, in a mixed food product, will be used to determine whether a product is covered by the seafood HACCP regulations?
- Is a fermented soy product, which is labeled as tuna-flavored and contains tuna, subject to the provisions of the regulation?
- How will an inspection under the FDA HACCP program differ from an inspection before implementation of the HACCP regulation?
- What role does the National Marine Fisheries Service (NMFS) play in the implementation of HACCP?
1.What is HACCP Programme?
It is a systematic approach for the identification and assessment of hazards and risks associated with any food production process and defining the means of their control. It is currently the best system available for improving safety of foods.
2.What are Hazards and Risks?
It is a biological, chemical, physical or economic aspect of a food, which can cause illness or mental distress for a consumer.
Example: Bacteria: Salmonella, Listeria Toxins: Aflatoxins, PSP, DSP Chemicals: Pesticides, Antibiotic residues Foreign body: Glass, metal
Operational malpractices or other operations can also constitute a hazard if they lead to unacceptable contamination or growth and survival of harmful microorganisms.
Risk is an estimate of the probability or likely occurrence of a hazard.
Critical Control Point: Any step in a manufacturing process, which, if not controlled properly, may result in the occurrence of the risk so that the products are unsafe, unwholesome or a cause for economic fraud.
3.What are the main elements of HACCP?
A. Identification & assessment of hazards: An appreciation of the type of contaminants in the product that could cause harm to the consumer and a detailed understanding of how these hazards could arise.
B. Determination of Critical Control Points (CCPs): CCPs should be carefully chosen on the basis of the risk and severity of the hazard to be controlled and should be truly critical.
C. Critical limits: Determination of criteria and specified limits or characteristics of a physical, chemical or biological hazard which ensure the product is safe and of acceptable quality.
D. Monitoring of CCPs: The schedule of tests and observations recorded to report the status of a hazard at each critical control point in a production process to ensure that the hazards are kept below the critical limits.
E. Corrective actions: Remedial measures, which are adopted, when a critical deficiency is assessed or when a critical limit is exceeded in the food manufacturing process.
4.If a firm owns a seafood product but is not involved in it's processing, is the firm required to comply with the regulation?
No, but conversely the processor is required to comply with the regulation regardless of who owns the product.
5.If a custom seafood processor, such as a contract manufacturer, processes fish owned by another entity is the custom processor required to comply with the regulation?
Yes, if the custom processor is performing activities defined in the regulation as "processing", the processor is required to have and implement a HACCP plan to control those hazards that are reasonably likely to occur in the product. The processor is required to comply with the regulation regardless of who owns the product.
6.How does the Seafood HACCP Regulation affect food service distributors? How does the regulation affect food service providers, hospitals, restaurants, and supermarkets?
Food service distributors that store fish and fishery products meet the definition of "processing" contained in the regulation, and are, therefore, covered if they are engaged in interstate commerce. However, food service providers, including hospitals, restaurants, and supermarkets, are retail establishments, and are, therefore, exempt.
A food service distributor must perform a hazard analysis and develop and implement a HACCP plan if the analysis identifies a hazard that is reasonably likely to occur. If a distributor stores only frozen or canned fish and does not otherwise engage in processing, it is not likely that a HACCP plan would be required. In either case, the distributor would still be required to comply with the sanitation provisions of the regulations.
7. Is a firm that manufactures tuna sandwiches from canned tuna and distributes (sells) the product to sandwich vendors covered by the Seafood HACCP Regulation?
Yes. The vendors themselves sell the product retail, and are, therefore, exempt. However, the manufacturer sells the product wholesale and is, therefore, covered. The manufacturer must also be engaged in interstate commerce in order to be covered by the regulation, but, with canned tuna, that is highly likely.
8.If a firm sells their product intrastate to another processor, such as a warehouse, which distributes interstate, is the original firm covered?
Yes, firms that sell their product intrastate to another processor with knowledge that the product will then be introduced into interstate commerce, or with good reason to believe that the product will be introduced into interstate commerce, are subject to the requirements of the seafood HACCP regulation.
However, a processor that distributes only to intrastate retailers or distributors with full expectation that the product will be ultimately distributed within that state, is not subject to the regulation. Situations such as these require careful consideration on a case-by-case basis.
9.If a firm receives raw materials from outside the state and distributes the finished seafood product inside the state, is the firm subject to the HACCP regulation provisions for this product?
Yes, this scenario constitutes interstate commerce, and subjects the product to the provisions of the regulation.
10.Is a firm that stores imported frozen fish and distributes it to local fast food restaurants subject to the Seafood HACCP Regulation?
Yes. Storage meets the definition of "processing" in the regulation. The fact that the firm handles imported product indicates than they are engaged in interstate commerce. If the firm is also the importer of the product, as defined by the regulation, it would also be responsible for meeting the importer verification requirements of the regulation.
11.Are public cold storage facilities exempt from the Seafood HACCP Regulation?
No, they are covered by the regulation. They are defined as "processors" for purposes of the regulation.
12.Are cash and carry distributors covered by the Seafood HACCP Regulation?
Cash and carry distributors often sell both retail and wholesale. To the extent that they sell wholesale, they are covered by the regulation.
13.Since the regulation excludes retail, is a retail seafood market that processes some products (e.g. smoked fish) for the wholesale market covered?
Any products that are sold wholesale must be processed in accordance with the regulation, provided that the product is in interstate commerce. This is true even if the firm's primary business is retail.
14.Must a retailer who imports products comply with the Seafood HACCP Regulation?
Retailers are exempt from processor provisions of the regulation. However, if a retailer is also an importer, as defined in the regulation, the retailer must perform the importer verification functions described by the regulations. There is no retail exemption from the importer provisions of the regulations.
15.Is an aquaculture producer a "processor" under the Seafood HACCP Regulation?
No, aquaculture producers are exempt from coverage. Treatment with carbon dioxide, bleeding, washing, and icing of otherwise unprocessed fish by the aquaculture producer is an integral part of the process of harvesting and getting the fish to market, and is, therefore, not considered to be processing. However, heading, gutting, or packaging of fish (e.g. retail or wholesale packages or cartons) performed by the aquaculture producer is considered processing, and would subject the producer to coverage under the regulations.
16.Does holding lobsters in a lobster pound constitute "holding" as defined in the HACCP regulation?
Yes, the practice of holding live lobsters until they are marketed is a form of processing, as defined by the regulations. Consequently, lobster pounds are subject to the sanitation and HACCP requirements of the regulation. At a minimum, safety concerns to consider in the development of a HACCP plan for these operations include water quality and use of animal drugs.
17.Which activities of a molluscan shellfish harvester are exempt from the requirements of the seafood HACCP regulation?
A person is exempt from all provisions of 21 CFR, §123 if they engage in the activity of harvesting molluscan shellfish without otherwise processing the shellfish. The following harvesting activities are not considered to be "processing":
- temporarily holding shellstock in bulk, or in containers, in a part of the same natural shellfish growing waters where harvested, where such holding is an integral part of the operation of getting the harvested product to market
- placing shellstock in containers as they are harvested
- placing shellfish shipping tags on containers of shellstock
- sorting or washing shellstock in the harvest area
- transporting by the harvester of shellstock in a boat or truck to a processing facility
18.Are molluscan shellfish wet storage facilities covered by the Seafood HACCP Regulation?
Yes, if the shellfish are harvested from the growing water and moved to another body of water (natural or artificial) in which they are then held awaiting marketing, the wet storage would be considered processing, as defined by the regulation, in that it constitutes "holding" or "storage." However, if, for example, aquacultured shellfish are harvested and then temporarily resuspended in a container in the same area during the remainder of the harvesting operation, the temporary storage would not be considered "holding," but rather a necessary part of the harvesting operation.
19.Does the exemption for transportation include company trucks, contract haulers, drayage firms and middlemen i.e., firms that buy products from various harvesters at the dock, load product directly into their trucks, ice the product, and transport the product to market?
The Seafood HACCP Regulation specifically exempts common carriers from coverage. Furthermore, it is not FDA's intent to seek compliance with the regulation for any form of transportation, regardless of who is performing the transportation, who owns the product, or who owns the vehicle. Control of hazards that may be introduced during transport should be addressed through a receiving CCP by the firm receiving the product.
20.Which activities of a harvest vessel are exempt from the regulation, under the definition of processing in 21 CFR, and which are not?
Specific examples of activities of fishing vessels that are exempt are:
- A fishing vessel that simply catches the fish or that catches, heads, eviscerates, or freezes the fish onboard the vessel, and then delivers the product to market, whether retail or wholesale, is exempt from the regulation.
- A fishing vessel that catches the fish and then processes the fish in any manner (e.g., cuts steaks and/or fillets or cooks), and then sells the product at retail (i.e., to the consumer or end user) is exempt from the regulation.
However, the following activities are not exempt from the regulation:
- A fishing vessel that catches the fish and then processes the fish in a manner that is beyond the scope of "heading, eviscerating, or freezing intended solely to prepare it for holding on board the harvest vessel" (e.g., steaking, filleting, cooking) and then sells the product, or a portion of the product at wholesale (i.e., with the intent that it will be resold to the consumer or end user), is subject to the requirements of the regulation.
Such an entity meets neither the fishing vessel exemption nor the retail exemption.
21.Do vessels that process fish or fishery products on board (i.e. factory vessels) meet the definition of "processor" in the regulation?
Yes, a processing vessel meets the definition of "processor" in the regulation.
22.Fish are frozen, bagged, and boxed on a harvest vessel, are sold upon docking, and are unloaded into the buyer's dockside storage. Is the vessel a "processor" and, therefore, covered by the regulations?
If the packaging is only what is minimally necessary in order to facilitate transport to the shore and subsequent unloading (e.g. totes or bulk bins), the operations onboard the harvest vessel would not subject it to the regulation. However, if the harvester places the product in packaging designed for marketing purposes (e.g. wholesale or retail packages or cases), then the operations onboard the vessel constitute "processing", and the vessel is covered by the seafood HACCP regulation.
23.Since fishing vessels and carriers can have a marked influence on the safety of seafood products and yet are exempt from the Seafood HACCP Regulation, what can a processor do to minimize hazards that may be introduced at these points?
When a food safety hazard can be introduced or made worse by a harvester or carrier (e.g. histamine development in scombroid species of fish on the harvest vessel or pathogen growth in cooked, ready-to-eat fishery products during transportation) the processor should include controls in his HACCP plan that require, as a condition of receipt, demonstration that the hazard has been controlled by the harvester or carrier. For example, the processor may require documentation from the harvest vessel that shows that the scombroid species of fish were handled properly (e.g. cooling or icing log). Or, the processor may require documentation from the carrier that shows that the cooked, ready-to-eat fishery products were held at proper temperatures (e.g. temperature recorder chart).
24.When does temporary storage by a fisherman become "processing" as defined in the HACCP regulation?
Holding or storage by a fisherman is not covered by the regulation when the temporary storage is a necessary component of harvesting and getting the product to market. However, such holding is covered if it is performed while a marketing decision is being made.
The following activities are temporary storage that are not covered by the regulation:
- A fisherman holds his catch in port until he can deliver it to market, or until it can be picked up for delivery to market.
- The following activities constitute "holding" and are covered by the regulation:
- A crab fisherman unloads live crabs and stores them for several days until he has enough to sell.
- A crab fisheman stores his and others' crabs in his cooler, until they are picked up by a truck or sold elsewhere.
- A wholesale dealer buys crabs from fishermen and holds them for pick up by a common carrier.
25.Does the Seafood HACCP Regulation replace the Current Good Manufacturing Practice Regulations (21 CFR 110) for fish and fishery products?
No, the requirements of Part 123 are in addition to the requirements of other FDA regulations, including Part 110. Section 123.5(a) of the Seafood HACCP Regulation states that the GMPs continue to be applicable to seafood processors in determining whether their facilities, methods, practices, and controls are safe and whether those products have been processed under sanitary conditions.
26.Are all processors of raw fish species that have a parasite hazard required to control that hazard regardless of the intended use of the product (e.g., consumed raw, or cooked)?
No, a processor only needs to control the parasite hazard under the following conditions:
- the processor has reason to know that the fish will be consumed raw, OR
- the processor markets the fish for raw consumption, i.e., represents, labels, or promotes the product to be consumed raw
27.Is the hazard of parasites reasonably likely to occur in the processing of fish roe during which the eggs are removed from the scene and then processed in brine?
No, ordinarily under these circumstances, the brine would serve to separate the parasite larvae from the fish eggs, i.e., the parasite larvae would sink and the fish eggs would float.
28.With respect to changes that require processors to reassess their hazard analyses and HACCP plans, what do the terms "sources of raw material" and "consumers of finished product" refer to?
"Sources of raw materials" refers to the harvester or supplier of the raw material. If, for example, a processor expands or changes the area from which he purchases a species of fish to include an area in which a harvest closure based on chemical contaminants exists, the processor should reassess whether it is necessary to change his plan to accommodate the new hazard.
"Consumers of product" refers to the ultimate consumer, who buys the product at a retail establishment or consumes it at a food service establishment. If, for example, a processor changes his marketing for a product to specifically target persons in hospitals and nursing homes, or other high risk populations, he should reassess whether it changes the significance of potential hazards in the product.
29.What are the factors that make Clostridium botulinum a hazard that is reasonably likely to occur in a fishery product?
Some factors which contribute to the likelihood of a Clostridium botulinum hazard include packing the product under vacuum, in a modified atmosphere, in a hermetically sealed container or in oil, and/or applying a moderate heat treatment in combination with salt at less that 10%.
30.Is Clostridium botulinum (C. bot.) a hazard in vacuum packaged raw seafood products that are stored and distributed refrigerated?
Yes. Refrigeration alone is not a suitable barrier without adequate temperature control (monitoring) from processor to consumer. If a processor intends to pack raw fish in a vacuum package, he will need to establish adequate safety controls. The most likely procedure would be to carry out innoculated pack studies.
31.Is the hazard of Paralytic Shellfish Poisoning (PSP) reasonably likely to occur in lobster?
No, based on current information, it is not reasonably likely that lobster meat will contain a toxic quantity of PSP. This is in part because the amount of toxin in lobster meat, even from lobsters caught in the same suspect location, is highly variable.
32.Is it true that no HACCP plans are required for raw shrimp and non-scombroid fresh fish?
All processors must conduct, or have conducted for them, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur in their product. This hazard analysis must be conducted for each location, each process and each kind of product processed. If no safety hazards are determined, then no HACCP plans are required.
Raw shrimp and non-scombroid fresh fish may not need a HACCP plan, but this must be determined in each individual processor's situation. For example, if the raw shrimp comes from aquaculture farms, then the use of animal drugs is a hazard that must be addressed by the primary processor. Also, parasites may be a hazard in some non-scombroid fresh fish that are marketed for raw consumption.
33.Must sulfites be identified as a significant hazard in a HACCP plan for shrimp?
In all cases, sulfites should be considered in the hazard analysis for shrimp, and in most cases sulfites will be a hazard that must be controlled in a HACCP plan. However, in geographical areas where sulfites are not used in shrimp, the hazard may not be reasonably likely to occur. Another example in which the hazard may not be reasonably likely to occur is shrimp from a harvester that immediately freezes shrimp on board the harvest vessel without using sulfites.
34.What would a typical HACCP plan look like for a wholesaler who buys product from a processor? For a retailer that buys directly from watermen? For watermen who sell directly to retailers? For a small seafood company?
All seafood processors, as defined by the regulation, must perform a hazard analysis, and must develop and implement a HACCP plan that addresses all of the hazards that the hazard analysis identifies as reasonably likely to occur. For example, hazards such as pathogen growth in cooked, ready-to-eat seafood or histamine development in scombroid species of fish as a result of temperature abuse during storage must be addressed in the wholesaler's plan if they are reasonably likely to occur.
However, certain environmental hazards, such as pesticides or natural toxins from the harvest area need not be covered by the wholesaler if he is purchasing the product from a processor that is also subject to the regulation. Those hazards should be fully controlled by the primary processor, and are no longer reasonably likely to occur by the time the wholesaler has received them.
Neither retailers nor watermen are subject to the seafood HACCP regulation. However, if the waterman processes further than heading, gutting, or freezing onboard the harvest vessel, he would be covered by the regulation. FDA has made certain recommendations to State agencies that regulate retail foods related to appropriate controls for retailers that purchase seafood directly from watermen. These are contained in the FDA Food Code. In general, in states where these recommendations are adopted, such retailers would be required by state regulation to develop a HACCP plan.
There are no special features of a HACCP plan for a small processor as opposed to a plan for a large processor. The plan is not dependent upon the size of the firm, but rather by the number and nature of the hazards.
35.Can a single HACCP plan cover frozen, raw, breaded shrimp and frozen, parfried breaded shrimp?
Yes, one plan could ordinarily be used for both products, because the same hazards ordinarily apply to both products. Both are battered and breaded. Neither product is ready-to-eat, e.g., parfry does not result in a cooked shrimp product. For both products the hazard of Staphylococcus aureus toxin formation in the batter is reasonably likely to occur and is of concern because the toxin could survive frying by the consumer.
36. Must a firm have a separate HACCP plan for each different size shrimp it processes, when the only differences are the cooking times (e.g., the critical limits)?
No, FDA would not object to grouping products [in one HACCP plan] that have the same hazards and controls, (e.g., monitoring, corrective action and verification procedures, and records), other than the critical limits.
37.Does the seafood HACCP regulation apply to low acid canned seafood (LACF) or acidified seafood?
Yes, the HACCP regulation does apply to LACF and acidified foods. However, as explained in section 123.6(e), it is not necessary for an LACF processor, domestic or foreign, to address the hazard of Clostridium botulinum toxin in their HACCP plans.
This hazard is already addressed under the LACF regulations, 21 CFR part 113 or 114, with which they must already comply. However, hazards, other than C. Botulinum that are associated with these canned foods (e.g., histamine in canned tuna) must be controlled by the processor's HACCP plan.
38.Is control of the thawing process critical to ensuring the adequacy of the subsequent cook step?
Each processor should establish the Critical Limits (CL) of the cook step in their process by a scientific study. The possibility of partially thawed product and its possible effect on the cooking process should be considered in the study. The study will establish whether the thawing process is critical, based on the processor's normal operating procedures.
39.Must crab processors conduct heat penetration studies on their products and temperature distribution studies on their retorts, even if they have recording devices to show that they are cooking for a minimum of 4.5 minutes at 240° F?
Not necessarily, but under ordinary circumstances, every crab processor should have information that scientifically establishes the adequacy of their cooking process. This information should be referenced in their HACCP plan. It is not necessary for every crab processor to perform their own heat penetration study, provided they process with the parameters of an existing study.
In addition to scientifically establishing the adequacy of their cooking process, every crab processor should have information that scientifically establishes the adequacy of their cooking equipment. This information should also be referenced in their HACCP plan. But again, it may not be necessary for each processor to independently perform temperature distribution studies in their cooking equipment. They may be able to rely on studies that establish that equipment of a particular design and operated in a particular manner will provide adequate temperature distribution. Some such studies may already exist in the literature.
40. Is the cook step a CCP for the control of pathogens in crab?
Yes, ordinarily the cook step should be considered to be a CCP for cooked-ready-to-eat products to eliminate pathogens on the raw material, unless the product receives a final heat treatment, such as pasteurization. To date, FDA is unaware of any studies that conclusively demonstrate that the cook step can be eliminated as a CCP for the processing of unpasteurized crabs.
41.The recommendations in the Guide for cooling extremely large tuna (600-1200 pound fish) to 50° F within 6 hours of death are impractical. What alternatives do the industry have?
If the guidance contained in the Guide is not practical, the processor has the option of scientifically establishing other limits that provide an equivalent level of control.
42.Because of the slow development of histamine at low temperatures, the recommendations in the Guide for time/temperature critical limits during processing, seem unduly restrictive. Are there suitable alternatives?
Yes, the next edition of the Guide will be modified to provide the following alternatives:
- For fish that have not been previously frozen –
A) The fish should not be exposed to temperatures above 70°F for more than four hours, cumulatively, before cooking (e.g., canned tuna "precook") or final freezing; B) The fish should not be exposed to temperatures above 40°F but below 70°F for more than eight hours, cumulatively, before cooking (e.g., canned tuna "precook") or final freezing;
- For fish that have been previously frozen –
A) The fish should not be exposed to temperatures above 70°F for more than twelve hours, cumulatively, before cooking (e.g., canned tuna "precook") or final freezing; B) The fish should not be exposed to temperatures above 40°F but below 70°F for more than twenty-four hours, cumulatively, before cooking (e.g., canned tuna "precook") or final freezing.
These recommended critical limits are designed to prevent the development of dangerous levels of histamine and are not necessarily appropriate for the production of high quality fish. They are only suitable for fish that have been properly handled prior to receipt by the processor, i.e., those that have met the recommended receiving critical limits.
However, for all fish (i.e., frozen or unfrozen) that were subjected to a corrective action as a result of a receiving critical limit deviation, the fish should not be exposed to temperatures above 40°F for more than four hours, cumulatively, before cooking (e.g., canned tuna "precook") or final freezing.
43.In industries like the canned tuna industry, where large quantities of fish (i.e., hundreds of tons) are received at a time from a single vessel, suppliers are usually quite stable, and there is a long history of histamine analysis with a low incidence of positive findings, the sample size for histamine analysis recommended in the Guide, seems excessive. Are there any alternatives?
Yes, there may be. The sample size recommended in the Guide is designed to provide a reasonable level of statistical assurance that a lot will not contain fish with histamine in excess of 50 ppm. However, there are several approaches that may be used to reduce the sample size from that which is recommended in the Guide. For example, the sample size could be safely reduced if the critical limit was also reduced (e.g., to 30 ppm). The sample size could also be safely reduced if the processor could demonstrate that there was a substantial history of compliance (i.e., low incidence of histamine findings above 50 ppm) from a stable group of suppliers. The principle of more intensive initial screening at receiving (i.e., with new suppliers), followed by less intensive screening as a pattern of compliance emerges with a particular supplier or group of suppliers is reasonable and is applied elsewhere in the Guide.
44.Does a subsequent processor need to ensure that a previous processor has actually controlled hazards in his product?
No, a subsequent processor need not verify that a previous processor is fulfilling the requirements of the regulation. It is FDA's role to verify compliance. Some processors have chosen to obtain written guarantees of compliance from their suppliers. These letters are not required by the seafood HACCP regulation.
45.In the case of fish that have a parasite hazard that are intended for raw consumption, is a label statement that the product should be cooked or frozen before consumption an acceptable control?
No, labeling is not an appropriate control measure for a hazard that affects the general population, as is the case with parasites. Freezing a fish by the processor is the only control measure of which FDA is aware that is both practical and effective for fish that are intended to be consumed raw and that are identified as having a parasite problem.
Processors that distribute a species of fish in the frozen state for raw consumption and the same species fresh for cooked consumption, are certainly free to identify the fish intended for cooked consumption with labeling indicating that it is not intended for raw consumption. However, a retailer using a product for raw consumption that is labeled for cooked consumption, could be placing himself in regulatory jeopardy with local food control ordinances.
46.What does the requirement for a yearly reassessment of the HACCP plan in Part 123.8(a)(1) mean?
At a minimum the HACCP plan must be reassessed annually to determine whether the hazard analysis is still appropriate and whether the plan effectively controls the identified hazard(s). The processor must consider how or if any changes in the firm's operations could affect the adequacy of the hazard analysis or the HACCP plan. (For example, changes in the kinds of raw materials used in the product, the suppliers of the raw materials, the product formulation, the equipment or operations used to process the product, the way in which the product will be used by the consumer, or the types of consumers likely to use the product could have major impact.) If the reassessment indicates a deficiency in the plan, the plan must be immediately revised.
Processors are free to perform the reassessment in any manner that works for them. For example, a "HACCP team" could discuss changes in the firm's operations since the last reassessment. Or, reassessment could also include a review of consumer or trade complaints, finished product or in-line samples, or of monitoring or corrective action records.
47.How should a processor measure the performance of a HACCP plan?
Measuring the performance of a HACCP program is termed "verification." Processors are required by 21 CFR 123.8 to verify their HACCP plan. Certain verification steps are mandatory, such as process instrument calibration, and review of processing, calibration, and corrective action records. Others are left at the option of the processor, such as finished product testing. Still others are required, but are intentionally left broad, such as the requirement to reassess the plan under certain conditions, and at least annually. This mix of requirements should allow the processor ample flexibility to design a verification program that meets his needs.
48.How often should a firm test for sulfites in frozen shrimp they receive, if they have a certificate that states the shrimp is sulfite-free?
It is reasonable to assume that this processor is not the primary processor because the product is frozen. The sulfite hazard should be controlled by the primary processor, and therefore need not be addressed by the secondary processor. Additionally, the processor should collect at least one representative sample for each new supplier, and analyze for sulfiting agents.
49.The hazard analysis need not be written. Must the reassessment of a hazard analysis be written?
No, whether conducted as part of an annual review or because a reassessment is required by a process change that might affect a product's safety, reassessment of a hazard analysis need not be written.
50.How long must sanitation records be held if sanitation is not part of the HACCP plan?
21 CFR 123.9(b) states that all records required by the regulation, including sanitation records, must be retained for one year for refrigerated products and two years for frozen, preserved or shelf stable products.
51.Must a seafood processor have a HACCP-trained individual do their hazard analysis, even if their product does not require a HACCP plan?
Yes, a HACCP-trained individual must perform the hazard analysis initially at least annually, and whenever there is a change in the firm's operations that might affect the hazard analysis, even if the product does not need a HACCP plan. However, the trained individual need not be an employee of the processor.
52.Must the processor review sanitation records under the HACCP regulation?
No, 21 CFR 123.11(c) requires a processor to maintain sanitation monitoring and correction records, but the firm need not review those records. This differs from the requirement at 21 CFR 123.8(a)(3) that processors review HACCP monitoring, corrective action, and calibration records within certain time constraints. As a practical matter, however, it would be prudent for processors to perform such a review of sanitation records in order to ensure that they are maintaining control of sanitation in the plant.
53.Are processors required to have a written sanitation standard operating procedure (SSOP)?
No, the seafood HACCP regulation does not require processors to have written SSOPs. However, a written plan is strongly recommended because an SSOP would help the processor identify the tasks necessary to meet the sanitation monitoring requirement in 21 CFR 123.11.
54.Should a processor of cooked-ready-to-eat products monitor its processing water for residual chlorine?
In some cases, yes. Water used in contact with cooked, ready-to-eat product must be potable. If the water is from a municipal source, no controls to ensure potability will likely be needed, except where the municipal supply is occasionally contaminated. If, however, the source is private, the microbiological quality (e.g., total coliforms) should be checked periodically - ordinarily at least once or twice per year. If chlorination is needed to ensure the potability of a private source, residual chlorine should be checked frequently - ordinarily at least daily. If recirculated water is used in contact with the product, the proper controls would depend upon the water temperature, the length of time between water replacement, and the method of water filtration/treatment.
55.Can controls for time/temperature abuse during processing or storage be included in a processor's sanitation standard operating procedure rather than its HACCP plan?
No, to the extent that time/temperature abuse that can lead to the development of a hazard (e.g., histamine development or pathogen growth) is reasonably likely to occur at a step in the process, time/temperature abuse must be controlled through HACCP rather than through sanitation monitoring. Monitoring of time/temperature in a HACCP plan must be at a frequency to detect loss of control that would result in the development of a hazard.
56.If the foreign processor does not have a formal HACCP plan but takes all steps necessary to assure safety of products, is this sufficient?
No, the regulations, section 123.6(b), require every processor (domestic and foreign) to have and implement a written HACCP plan whenever a hazard analysis identifies one or more food safety hazards that are reasonably likely to occur in the product.
57.How could ISO 9000 certification be useful to a foreign processing company in order to demonstrate compliance with the HACCP regulation?
An ISO 9000 plan may help facilitate the verification procedure, but it does not take the place of a hazard analysis nor a HACCP plan.
58.Has the EU accepted HACCP as a replacement for ISO when importing from companies outside the U.S.?
The EU does not require ISO for imported foods, although some buyers may require it. The EU does, however, require HACCP to be implemented by seafood processors who ship to the EU. The EU further requires that seafood processors shipping to the EU be on a list submitted to the member state inspection body by the competent inspection body in the third country.
59.Does the seafood HACCP regulation apply to imported low acid canned foods (LACF) or acidified foods?
Yes, but only to hazards other than Clostridium botulinum, which is addressed by the LACF regulations, 21 CFR parts 113 and 114.
60.Must an importer have a HACCP plan for its own operation?
No, the importer is not required to perform a hazard analysis or have a HACCP plan, unless it is also engaged in processing. The importer is only required to have and implement verification procedures to ensure that the foreign processor meets the requirements of Part 123.
61.Can the importer verification activities, i.e., performing affirmative steps, be conducted by the foreign processor?
No, the foreign processor cannot perform the verification affirmative steps for the importer.
62.Is it required that an importer hire a third party to perform its verification activities?
No, it is not required for an importer to use a third party to perform the verification activities as outlined in the HACCP regulations. The importer may perform these steps itself.
63.Does the importer need verification that Sanitation Standard Operating Procedures (SSOP) are being followed and monitored by a foreign processor?
Yes, the importer must verify that sanitation is being monitored by the foreign processor. Section 123.12(2) states that the verification procedures must ensure that the imported products were processed in accordance with the requirements of all of part 123, which includes sanitation monitoring procedures.
64.If an importer receives product from a country covered by a seafood HACCP MOU, does the importer need to maintain any HACCP verification documentation?
No, the existence of an MOU fulfills the importer's requirement under the seafood HACCP regulation unless the importer is also a processor, and no documentation is required. However, the importer should be in a position to demonstrate that the product came from a country covered by a seafood HACCP MOU.
65.Does a Memorandum of Understanding (MOU) signify that an acceptable HACCP program exists?
An active MOU applicable to fish and fishery products will signify that the country's authority for control of seafood for export has agreed to comply with Part 123 or that their seafood regulatory system is equivalent to the U.S. system. The MOUs may be product and/or processor specific and may not cover all the seafood products from the signatory country.
66.An active MOU applicable to fish and fishery products will signify that the country's authority for control of seafood for export has agreed to comply with Part 123 or that their seafood regulatory system is equivalent to the U.S. system. The MOUs may be product and/or processor specific and may not cover all the seafood products from the signatory country.
Yes, when the MOU is signed the importers will be removed from the import alert if the MOU covers the product and processor that are listed in the import alert. The country's agreement to take responsibility to verify processor compliance with the HACCP regulation requirements will fully satisfy the importer's verification requirements.
67.Can one product safety specification be used by several importers of the same product?
Can one product safety specification be used by several importers of the same product?
68.Can one product safety specification be used by several importers of the same product?
No, Part 123.12(a)(2)(i) does not require that importers test product to see if their product safety specifications are met.
69.Is it necessary for importers to insist that their product specifications be signed by the foreign processor or that the foreign processors write a letter guaranteeing adherence to the specifications?
No, it is not necessary. However, the importer may wish to have the foreign processors indicate in some manner an intent to meet the specifications.
70.Do product specifications need to address non-safety issues such as filth and decomposition?
No, the product specification requirement is for safety only. Specifications such as water activity, pH, histamine content and pathogen limits, are examples of specifications that importers might set in their efforts to ensure product safety. It is important to note than an importer's specifications are not necessarily the same as a processor's HACCP critial limits.
71.What should be the frequency of affirmative step procedures (i.e., How often should on-site audit visits be made or how often should a product be tested)?
The regulation does not specify frequency of the affirmative steps. Frequency should be as often as necessary to provide the importer confidence that the foreign processor is meeting the requirements of the seafood HACCP regulation. Frequency will vary with circumstances such as: the number and type of hazards associated with the product, the importer's familiarity with and confidence in the foreign processor, the particular affirmative step being undertaken, etc. It may be prudent to check more frequently initially and reduce the frequency over time, if initial results are satisfactory.
Under ordinary circumstances, reasonable affirmative step frequencies could be:
(A) monitoring records - every shipment
(B) continuing lot certification - once a year lot-by-lot certification - every lot
(C) foreign on-site inspection - once a year
(D) processor's HACCP plan/guarantee - once a year
(E) periodic tests/guarantee - test first three entries, if satisfactory - quarterly (Guarantee once a year)
72.How many of the six affirmative steps found in the regulation must be conducted by importers?
Importers need only conduct one of the listed affirmative steps. An importer can use a variety of affirmative steps for different suppliers and/or products.
73.Do HACCP plans and all sanitation and HACCP monitoring records held by importers as part of their verification program need to be in English?
Yes, part 123.l2(c) states that importer verification records must be maintained in English.
74.Do importer verification records (i.e., affirmative action step documents) need to be originals? For instance, the original HACCP plans or monitoring records received by importers may have been in a foreign language, and the importer may have had them translated into English; or, for the sake of timeliness, the monitoring records, HACCP plans, guarantee letters and certificates may be sent via fax.
No, the verification records held by the importer need not be originals. However, the copies need to be accurate and legible and the Agency reserves the right to obtain the originals if necessary.
75. If the importer chooses to visit the shipper or foreign manufacturer as a verification affirmative step, does the person visiting need to be HACCP certified?
No, there is no requirement that a person performing an on-site inspection for importer verification purposes be HACCP certified. However, the person should be competent to perform that task. Competency could include a through knowledge of the seafood industry sector, the principles of HACCP, the HACCP regulation, and Current Good Manufacturing Practices (GMPs).
76.When a third party certificate is used to demonstrate the foreign processor's adherence to the HACCP rule, what documentation is necessary? Is the third party's audit report necessary?
For third party certification complying with 123.12(a)(2)(ii)(B), the importer need only maintain on file either a lot-by-lot certificate of compliance or a certificate attesting to continuing compliance. However, the Agency reserves the right to request additional supporting documents, such as a copy of the full inspection report and documentation of the competency of the third party, if necessary.
77.If a foreign processor has determined that there are no safety hazards in its product, should the importer maintain a copy of the processor's hazard analysis?
The regulation does not require that a processor have a written hazard analysis. However, in the event that an importer had selected option 123.12(a)(2)(ii)(D) (maintaining a copy of the foreign processor's HACCP plan and a written guarantee of compliance with the HACCP regulation) or option 123.12(a)(2)(ii)(A) (obtaining HACCP and sanitation monitoring records) and there is no HACCP plan because the processor has determined that there are no hazards that are reasonably likely to occur, it would be prudent of the importer to be prepared to demonstrate that fact.
78.If a foreign processor has an adequate HACCP program, sends the same product to two importers, and one performs adequate verification and one does not, which products will be placed on detention without physical examination?
The importer that does not perform adequate verification will be placed on detention without physical examination for that product from that foreign processor.
79.Does the seafood HACCP Regulation supersede the National Shellfish Sanitation Program (NSSP)?
No, state shellfish control agencies implement the NSSP by adopting and enforcing regulations that are consistent with the NSSP. Processors of raw molluscan shellfish are required to comply with those state regulations. They will also be required to be in conformance with the provisions of the seafood HACCP regulation. The NSSP has recently been revised to incorporate the requirements of the seafood HACCP regulation, and changes in state implementing regulations and guidelines will soon follow, as needed.
80. Is it necessary for a shellfish dealer who removes the tags from containers of molluscan shellfish during processing, to save each individual tag, or can the dealer save a tag from each lot and the invoice to demonstrate how much of the product was purchased and from whom? Currently this practice is allowed by the NSSP.
No, this practice would also be acceptable under the provisions of the seafood HACCP regulation. In fact, the regulation does not specifically require that processors retain any tags, although that remains a requirement of the NSSP. Under the regulation, processors may transcribe the relevant information from the tags onto a more traditional record.
81.Does the Seafood HACCP Regulation permit the heat treatment of molluscan shellfish harvested from unapproved growing waters?
Yes, under certain conditions. The seafood HACCP regulation contains specific receiving controls for raw, molluscan shellfish that are mandatory unless the shellfish are processed in a way that "ensures the destruction of vegetative cells of microorganisms of public health concern." In other words, the processor is required by the HACCP regulation to obtain shellfish from approved growing waters unless he intends to heat treat them sufficiently to eliminate the pathogens of concern. Under those conditions, the processor may obtain the shellfish from unapproved waters. However, the processor must also ensure that any chemical or natural toxin hazards are controlled.
Additionally, State statutes do not, at present, allow harvesting from unapproved waters, unless the molluscan shellfish are going to be relayed or depurated, and then only if subjected to certain controls.
82.Are there any specific cooking temperatures required for a fishery product to be considered to be "fully cooked" or "ready-to-eat"?
No, if the protein is coagulated throughout the product, the processor should consider it likely that some consumers will consume the product without further cooking. In this case, the cooking process should be designed to eliminate vegetative pathogens of public health concern.
83.Will there be a HACCP logo for products?
No, FDA has no current plans for an approved HACCP logo for seafood products.
84.What percentage of seafood, in a mixed food product, will be used to determine whether a product is covered by the seafood HACCP regulations?
There is no minimum percentage of fish that causes a food to be subject to the provisions of the seafood HACCP regulation. A product is subject to the regulations, if "fish" is a characterizing ingredient.
85.There is no minimum percentage of fish that causes a food to be subject to the provisions of the seafood HACCP regulation. A product is subject to the regulations, if "fish" is a characterizing ingredient.
Yes, the use of a fish name on the label of a product clearly indicates that the fish is the characterizing ingredient. The product is therefore a fishery product as defined by the regulation and is subject to the regulation.
86.How will an inspection under the FDA HACCP program differ from an inspection before implementation of the HACCP regulation?
Previously FDA inspections of seafood processors concentrated on the sanitation conditions and practices of the processor, as well as the quality of the product. There was also considerable emphasis on end-product testing for microbiological and other defects. Under the HACCP program, these efforts will continue. However, the focus of the inspection will be on the adequacy of the processor's controls to prevent the occurrence of food safety hazards. In particular, the inspector will assess the adequacy of the processor's HACCP plan, observe the degree to which the plan is implemented in the plant, and review records of critical control point monitoring and corrective action. The inspector will also review the processor's sanitation monitoring program.
87.What role does the National Marine Fisheries Service (NMFS) play in the implementation of HACCP?
The NMFS continues to operate voluntary seafood HACCP program that includes not only safety but also non-safety hazards such as quality and economic fraud.
Last updated: 29-3-2007
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