Barel - Review - feed safety noxious compounds inspection ... · Dr. Shimon Barel Department of...

Review of the Needs and Composition of the

Feed Safety and Noxious Compounds Inspection System in the Israeli VSAH

Dr. Shimon Barel

Department of Toxicology

Kimron Veterinary Institute,

Veterinary Services and Animal Health,

Ministry of Agriculture

Bet Dagan, January 2013

Review 2013 - Feed Safety Israeli Veterinary Services and Animal Health

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Contents Executive summary 4

Acknowledgements 6

1. Introduction 7

1.1 Background 11

1.2 Scope and purpose of the feed safety residue analysis in VSAH 14

2. Current status of the Israeli feed market - production and trade 17

2.1 Imported feed ingredients 18

2.1.1 Domestic animals feedstuffs 21

2.1.2 Food producing animals / Feed consumers / self producers 22

2.1.3 Pet food 30

2.2 Feed mill plants 35

2.3 Merkaz Mazon (Feeding centers) 38

2.4 Recycling of chicken manure and processed animal waste 41

3. Feed safety - Major hazards in animal feed and feed ingredients

related to animal and public health 44

3.1 Selection and regulation of noxious substances of concern in feed 44

3.2 Microelements (toxic elements) 46

3.3 Mycotoxins 51

3. 3.1 Action, Guidance and Advisory Levels and Tolerances 52

3.3.2 Mycotoxins and Regulatory Limits US,EU and Israel 53

3.3.3 Ergot alkaloids 60

3.3.4 Use of Contaminated Grains 61

3.3.5 Blending 61

3.4 Pesticides and environmental pollutants 63

3.4.1 Pesticides 63

3.4.2 Dioxins and dioxin-like chemicals (DLC) 66

3.4.3 Persistent organic pollutants (POPs) 72

3.5 Coccidiostats 74

3.6 Hormones and Estrogen like compounds (xenoestrogens) 80

3.7 Other regulated undesirable substances in feed 83

4. Lab Activities - analysis and detection of noxious substances

in animal feed and feed ingredients. 89

4.1 Feed safety analytical test process 90

4.2 Sampling , sampling plans and feed safety surveys 91

4.2.1 Procedures for sampling and collecting powder, grain and liquid samples 92

4.2.2 Required number of samples and annual survey 94

4.3 Sample preparation requirements for methods of analysis for feed 100


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4.4 Methods of analysis for the detection of undesirable substances 102

4.4.1 Analytical methods and tools for selected hazards 104

4.5 Performances of analytical procedure and estimated cost of lab. services 107

4.6 Medicated feed 110

5. Analytical instruments and sample preparation tools for feed

safety laboratory 111

5.1 Equipments and means used by international feed safety laboratories 117

5.2 Screening methods – to analyze more compounds in less cost and time 118

5.3 Instrumentation challenges and testing requirements 120

5.4 Sample preparation challenges 121

5.5 Reference material (standards) 122

6. Feed safety laboratory needed staff and expertise 123

6.1 Functional feed safety laboratory and organizational structure 123

7. Collaboration with allied laboratories in feed safety and quality tests -

Local labs. Capabilities 126

7.1 Candidate laboratories for collaboration - local industrial and

commercial labs capacities 127

8. Feed safety risk management influence of feed market

components on feed safety matters 134

8.1 Industry QA/QC labs and government labs 136

8.2 Consumers and laboratories service 136

9. Import of feed and feed ingredients to Israel 137

9.1 Imported feed products - types and market size 141

9.2 Sampling of imported bulk feed for lab testing (Research & Development) 142

9.3 Feed safety – shipment certification 145

10. Recommendations 146

10.1 National feed and food control strategy 147

10.2 Infrastructure Development 147

10.3 Prevention of risks, in animal feed associated with public health 148

10.4 Emergency response 148

References 149

Appendices 154

Appendix A. EU Directives

Appendix B. FDA’s Animal Feed Safety System (AFSS) Project Plans

Appendix C. AAFCO 2009 official publication– Model feed safety program

Appendix D. CODE OF PRACTICE ON GOOD ANIMAL FEEDING

Appendix E . IDF/FAO/IFCN World Mapping of Animal Feeding Systems in the Dairy Sector, Israel , 2011


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Executive summary

The Israeli feed safety legislation, which came to prominence in the early 1970's,

has undergone a major change from simple feed safety and quality regulations to a

more holistic concept of control of food safety and quality throughout the whole food

production chain, from farm to the end user table. The responsibility on the

implementation of the new feed law was moved from the Plant Protection Inspection

Service (PPIS) to the Veterinary Services and Animal Health (VSAH).

The Israeli regulation that deals with feed safety and quality comes under the PPIS

within the Ministry of Agriculture (MoA). PPIS enact these Regulations under the

authority of Control Commodities and Services Order 1971, PPIS has been in

charge of inspection of feed production and trade since 1971.

The Israeli food and feed industry is showing increasing interest in Quality Control

and Safety. The accelerated rate of investment in technologies, producing

sophisticated and competitive food products for export and the local market, are

responsible for an awareness of the need for institutionalized quality control and

safety in the whole food chain from farm to the consumer table.

Feed and Food safety laboratories, analyzing and testing for potential contaminants

require specialized instrumentation and methodological expertise to perform

analyses and produce rapid results. The need for the quality and consistency of

laboratory equipment and techniques also contributes to decision process about

investment in sophisticated and expensive analytical instruments.

The feed safety lab aims to ensure food safety through vigorous scrutiny of

potentially hazardous residues and contaminants in line with current legislation. The

central official laboratory for feed control should be specialized in analyzing small

molecular weight compounds in diverse feed matrices. Analyzing and testing for

potential feed contaminants requires specialized instrumentation and methodological

and laboratory staff expertise, to perform analyses and produce rapid results.

The primary risk of feed contaminants is for the farm animal themselves; however,

feeds can also be a major vehicle for the presence of bio-accumulating pollutants in

human diet. This is especially so in vulnerable farm animal productions, such as

aquaculture or grazing ruminants.


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Critical risk assessment issues include the characterization of toxicological hazards,

the possible pathways of feed contamination and the carry-over of parent compound

or metabolites to foods of animal origin as well as the pinpointing of situations that

may require risk management measures.

Some examples are considered in detail while taking into account the assessments

performed by the Israeli regulation authorities, European Food Safety Authority and

US FDA- Center for Veterinary Medicine (CVM):

(a) Feed additives and cross-contamination by coccidiostats;

(b) Mycotoxins and the endocrine disrupting mycotoxin zearalenone;

(c) Trace elements and speciation (toxic elements)

(d) Persistent organic pollutant (POPs)

(e) Dioxins and dioxin like compounds (DLC)

(f) Pesticides

(g) Medicated feed

Diagnostic health risk assessment, considered as a tool for decision-making in field

situations, is also reviewed with regard to unavoidable, long-standing (e.g.

methylmercury) and short term contamination instances.

Management of feed contaminants relies primarily on the implementation of good

practice in feed production; specific research needs may target feed sources less

prone to contamination as well as safe and effective detoxifying agents or

technologies. Overall, the risk assessment of feed contaminants has a critical role in

veterinary public health both as a basis to define the reference thresholds for

prevention, as well as guidance for risk diagnosis and field intervention in

contamination events.


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Acknowledgements

The aim of this report is to present representative and updated data pertaining to

the feed safety laboratories activity and operational needs. This Review submitted to

Veterinary Services and Animal Health (VSAH) and Kimron Veterinary Institute (KVI)

management, as a prerequisite activity toward EU twinning program and incoming

responsibility and implementation of the new Israeli feed law.

The main objective is to characterize a new function of Feed Safety Laboratory in the

VSAH which would be dedicated to the inspection of animal feed and forage.

The author also thank for their collaboration:

Prof. Alan Shlosberg – Head of Toxicology Dpt. , KVI

Dr. Laurence shore – Toxicology Dpt., KVI

Dr. Erez Lubrani – Veterinary drugs control, VSAH

Ms. Rina Ashkenazy- Head, Chemistry Department (Pesticides, Animal feed), PPIS

Mr. Ronen Yaron – Information Systems Services, MOAG

Dr. Shlomo Garazi – Chief Import & Export Veterinary Officer, VSAH

Dr. Mishel Balaish and Ms. Rima Diakover – Epidemiology Dpt., VSAH

Dr. Noach Miler, FIBRO Israel, Koffolk , feed additives and Premixes manufactures.

Dr. Ran Solomon – Nutrition Dpt., AMBAR, GRANOT Milling and Feeding Centers.

Dr. Gabi Adin – Head of the Cattle Husbandry Department, Extension Service, MOAG

Dr. Avi Dvorin – Nutrition Dpt., MILOUBAR FEED CENTERS, Miluot, Haifa Bay


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1. Introduction

Consumers are increasingly aware of, and sensitive to, food safety issues and their

linkage to animal production, including feeding practices. Feed manufacturing is a

vital and active industry in Israel, providing food for both food-producing animals,

and non-food producing animals including household pets, and zoo animals.

Exercising adequate and appropriate control over the ingredients used in these feeds

and the process of their manufacture can have significant impact on the health and

well-being of the animal. It may also have significant impact on human health,

especially for feeds given to food-producing animals. Animal drugs are incorporated

into feeds to produce medicated feeds because feed is the most feasible source of

administering animal drugs on a daily basis.

After a few years "gestation period," of discussion and evaluation by numerous

committees within the Ministry of Agriculture, the feed safety Protection Regulations

under the supervision of the Plant Protection and Inspection Services (PPIS) as

Plant Import, Plant Products, Pests and Regulated Articles, underwent radical

revision. This revision is now almost complete and the new regulations are in the

process of being promulgated.

The feed producers and feed importers in Israel are constantly under increasing

regulatory pressure to demonstrate that the safety of feed products and feed

ingredients placed on the market are guaranteed. The Israeli regulation that deals

with feed safety and quality comes under the PPIS within the Ministry of

Agriculture (MoA). PPIS enact these Regulations under the authority of Control of

Commodities and Services Order, inspection of feed production and trade since

1971.

The purview of PPIS includes the control of feed quality. In order to scientifically

support a high level of feed safety, a long and comprehensive activity of inter-

ministerial advisory board containing members from PPIS, VSAH, SHAHAM

(MoA extension services), Ministry of Health, feed industry representatives as

well as public organizations such as HA-HAKLAIT assists the PPIS activity.

These entities make the important decisions on the Maximum Residue Limits

(MRLs) of potential feed toxicant/contaminants for Israel. These MRLs play a major

role in the new Israeli feed law. This committee on determining MRLs can be

reconvened at any time to reconsider new data from Israel or abroad, and can


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change MRLs or include new undesirable substances/contaminants in annual feed

safety program if the need be.

The regulations, which were initially promulgated in the 1970's, have undergone

major transformations. What was once straightforward feed safety and quality

regulations have now become comprehensive feed safety regulations with a strong

focus on undesirable substances in feedstuffs and with a vision to control and

improve the safety and quality of the whole food production chain from farm to the

end user table. The responsibility on the implementation of the new feed low and

feed safety laboratory tests and measurements, was shifted from the PPIS to the

Veterinary Services and Animal Health (VSAH).

The Veterinary Services and Animal Health (VSAH) have the responsibility to enforce

the new coming feed law and to ensure that foods for man and animal are safe and

to avoid animal risk of intoxication. The VSHA has also the responsibility for the

introduction of new feedstuffs into the Israeli feed market.

Within VSAH, Kimron Veterinary Institute (KVI) has the diagnostic and analytical

capability to enforce the new incoming feed safety standards and regulations. The

Toxicology Dept. will be responsible for laboratory testing of the animal feed supply,

ensuring that it is safe and healthy, and that the incidence of harmful residues in

human food derived from animals is minimized. This report introduces processional

background and recommends how to address this responsibility as it relates to

chemical contaminants and undesirable substances (Flowchart 1), except

Bacteriology, GMO, meat and bone meals (MBM), processed animal proteins (PAP)

and BSE matters.

The new legislation, the training and guidance in the Twinning Project (supported by

the EU under European Neighborhood Policy) and the consequent development of

the animal feed control capability within the VSAH, will bring about marked changes

in animal feed control in Israel, to ensure maximal food and feed safety. These

changes will address various obligations comprising of:

1. Responsibility. Feed operators will be registered and are responsible for the

safety of the feedstuffs which they import, produce, transport, store, sell or provide

without cost. Farmers are responsible for the feedstuffs that they use in animal

production. This is the basic principle of Feed Control. In order to ensure food and

feed safety, feed suppliers and producers will be responsible for examining

feedstuffs for potential toxicants. The feed safety control system will periodically


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sample and analyze feedstuffs from all feed operators to ensure compliance with the

responsibilities of the feed operators.

2. Prevention. Feed operators will identify and regularly review the critical points in

their processes and ensure that pre-determined controls are applied at these points.

3. Safety. Feed operators will not supply any feed thought, known or found to be

potentially harmful. The new Feed Regulations that will be part of the Feed Law will

list all the feedstuffs regarded as being suitable and safe. Any substance not in that

list, including "non-conventional" feedstuffs, will have to be shown to be suitable and

safe, as they are supplied, and also during conditions of storage.

4. Traceability. Feed operators will have to be able to rapidly identify the source of

any feedstuff and to ascertain the route of supply to all recipients. This will be done

mainly by identification / marking and tracking of feedstuffs.

5.Transparency. Feed operators will immediately inform the

authorities if they have any reason to believe that any of their feed is potentially

unsafe. Feed operators will be encouraged to ensure availability of feedstuff control

practices and results to their clients through newsletters and the internet.

6. Emergency. Feed operators will immediately inform the competent authorities

and all recipients if they suspect, know or find that a feedstuff is potentially unsafe.

They will immediately start a withdrawal of feedstuffs (recall) from all supply routes

and recipients.

7. Cooperation. Feed operators will cooperate with the competent authorities in

actions planned and taken to avoid or reduce risks.


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Flowchart 1

Clinical problems

Chicken manure

Botulism (Bacteriology Dpt.)

Coccidiostats (TLC/LC/MS)

Feed

Heavy metals (ICP, ICP-MS)

Mycotoxins, Pesticides, Environmental contaminants (GC/TLC/LC/MS)

Feed

Toxicology

Microbiology (Food hygiene lab.)

Testing in response to

incidence reports

Tests required before introduction of new feeds

Antibiotics (Agar diffusion- Screening)

Heavy metals (ICP-MS)

Pesticides (GC/LS/MS)

Herbicides (GC/LS/MS)

Coccidiostats (TLC/LC/MS)

Mycotoxins (TLC/LC/MS)


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1.1 Background

Animal feed can be simple forage or can be a complex matrix of many ingredients,

with concerns about inherent toxic substances in some forage plants, added

veterinary drugs, and contaminants such as mycotoxins, toxic elements of risk (As,

Cd , Pb and Hg the "so called" heavy metals) or industrial chemical contaminants.

Most feeding stuffs and by-product in feeds are variable in composition. Only very

few, such as dried whole whey, are uniform in composition. Feed analysis provides

information for:

1. Veterinary and public health Inspection services, to evaluate the risk to animals

and the risk exposure of population.

2. Farmers, to optimize nutrient utilization in animal feeds

3. Feed compounders, to prepare feed mixtures suitable for different animal

Production systems and to avoid risk to animals and to public health

4. Researchers to relate animal performance to feed characteristics and the

potential effects of contaminants in food chain.

Manufacturers do everything they can to ensure that harmful substances are not

present, or that they are effectively eliminated before the food is consumed. This can

be achieved by following good manufacturing practice regulations specified by the

government for specific food products and by having analytical techniques that are

capable of detecting harmful substances. In many situations it is important to use

analytical techniques that have a high sensitivity, i.e., that can reliably detect low

levels of harmful material. Food and feed manufacturers and government

laboratories routinely analyze food products to ensure that they do not contain

harmful substances and that the food production facility is operating correctly.

The VSAH as many other regulatory food and Feed safety systems, is faced with a

demand for efficient enforcement tools, for quick decisions or when confronted by

large numbers of samples, e.g. at entry points of shipments, trading situations, on

contamination sites or in case of feed safety crisis. Analysis of the safety properties

of a food or feed material depends on the successful completion of a number of

different steps: planning (identifying the most appropriate analytical procedure),

sample selection, sample preparation, performance of analytical procedure, statistical

analysis of measurements, and data reporting

This review will cover the main issues which prompted developments in quality

assurance and control of analysis. Information will also be given on accreditation of


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laboratories, together with useful addresses. Subsequent sections will describe

standard and widely accepted methods, highlight areas that require particular

attention and refer to recent developments in feed analysis. Topics covered will

include: sample preparation, analysis of major quality components carried by feed

mills QA laboratories (e.g. dry matter, ash and minerals, crude protein, fat, fibers

and starch) and of undesirable substances that can effect animal and public health

and should be inspect by governmental bodies (e.g. microelements, mycotoxins ,

pesticides and other contaminants).

In Many countries there is a Feed Contaminants Program (FCP) provides

guidance for:

A. Collection of animal feed samples and analysis for pesticides, industrial chemicals,

dioxins, elements, mycotoxins , microbes, genetically modified organism (GMO),

meat and bone meals (MBM) and Processed Animal Protein (PAP).

B. Surveillance of the feed industry and feed supply system to identify potential

problem areas and additional sampling of these problem areas to ensure compliance.

C. Investigation of violative findings.

The scope of the program includes, but is not limited to:

A. submitting an annual feed contaminants report

B. developing national sampling plans.

C. defines the analytical priority for contaminants in feeds and feed ingredients.

D. coverage of feed and feed ingredients to determine microbial contaminants,

Under this program, the commodities collected and analyses performed may vary both

during the year and from year-to-year. Many resources are invested to maintain

adequate coverage of imported products and to address local feed production

contamination problems.

Animal Feed - Impact on Food Safety

Feed can become significant over the lifetime of an animal and result in unacceptable

residues in human foods such as meat, milk, and eggs. Three classes of compounds

are of particular interest to the VSAH: (a) dioxins, (b) mycotoxins and (c) toxic

elements.


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Dioxins

Toxicokinetic models have been developed to estimate the transfer rates of dioxins

to animal tissues.

As such, implementing controls for dioxins in feed represents an important step

towards reducing dioxins in the food chain. In particular, screening programmes

have indicated that dioxins may arise in feed via their presence in mineral sources,

such as clays, recuperated copper sulphate, zinc oxide; food by-products; and fish

by-products such as fish meal and fish oils.

There is a need for development/improvement of inexpensive and accurate screening

methods. Feed and food exposure studies are necessary to account for all sources of

dioxin entering the feed chain.

Mycotoxins

In the last decade, many studies have been conducted on mycotoxins. Most

frequently occurring mycotoxins (aflatoxin B1, ochratoxin A, zearalenone, fumonisin

B1, deoxinivalenol,T-2 and HT-2) are currently considered for their effects on animal

health. However, when focusing on how mycotoxins play a role in food safety,

attention should be limited to mycotoxins that are known to be transferred from feed

to food of animal origin, as this food represents a significant route of exposure for

humans.

Although the scientific community is aware of the following transfers from feed to

food: aflatoxin B1 to liver, aflatoxin B1 to milk as aflatoxin M1, aflatoxin B1 to eggs

as aflatoxicol; ochratoxin A to meat; deoxynivalenol to meat as DOM1; ingestion of

zearalenone or injection of zearalenol to meat, evaluating transfer rate and route of

exposure in humans is restricted to aflatoxin B1 for animals producing milk.

Animals fed on aflatoxin contaminated feed do not show symptoms of aflatoxin

toxicity. Feeds most susceptible to aflatoxin are: cereals (especially maize),

cottonseed, peanut and copra. Aflatoxin contamination is not homogeneous; it is

therefore very important to apply an appropriate sampling method. Feeds having a

significant aflatoxin contamination should not be fed to dairy cows or other animals

producing milk for human consumption or to other food-producing animals.

There is some evidence to suggest that mycotoxins can concentrate in dried distillers’

grains with solubles (DDGS) during the processing of grains for ethanol production.


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Toxic elements of risk (Heavy metals)

Cadmium is a ubiquitous contaminant that is present in many feed and feed

ingredients, in particular minerals, and forages grown near smelting and mining

areas. Arsenic and mercury are toxic elements which are widespread in the

environment and which can be found in many feeds, in particular in feeds of marine

origin. Lead is also a ubiquitous contaminant. In addition, Copper toxicity is a

problem for Israeli sheep.

1.2 Scope and purpose of the feed safety lab in VSAH

Within the overall role of securing food safety and ensuring fair trade practices in the

feed trades, the objectives of the feed safety lab in VSAH are as follows:

A To review the current state of knowledge on safety of Israeli animal feed

production, the impact on public health and national trade.

B To analyse the Israeli feed safety current situation, in comparison with

international standards addressing animal feed.

C To identify relevant areas to implement specific standards for animal feed,

on the basis of scientific evidence relevant to ensuring the safety of animal feed.

D. To provide database, focused on feed safety matters that have an impact on

food Safety, public health and feed trade, for further action required at national

level, and recommend specific activities needed.

E To evaluate and update the list of undesirable substances checked in Israel

according to international standards in aim to improve Israeli feed and food

safety.

F To increase laboratory capacities of food safety in Israel from farm to fork.

This review is not discuss in any depth, issues such as the use and labeling of

genetically modified organisms (GMOs,), BSE, animal health or traceability, as these

issues should be under consideration of the Israeli veterinary feed inspection service.

The GMO inspection in Israel, is under the responsibility of PPIS. The MoA Seed

Regulations (Genetically Modified Plants and Organisms - GMO) - 2005 were tried to

organize this topic.


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ort Feed and Food supp toconsumer table activities from farm to VSAH- 1.Fig

safety policy

Feed additives

producers &

suppliers

21%

Pet food

producers and

suppliers

34%

Industrial by-

products

suppliers

11%

Feed raw

materials

importers

11%

Feed mills

23%

Producers /Suppliers category (under inspection) No. of P/S

Feed mills 56

Feed raw materials importers 28

Industrial by-products suppliers 28

Pet food producers and suppliers 84

Feed additives producers & suppliers 51

Total 247

Chart 1: Inspected Israeli feedstuffs producers and suppliers -2010 (Source PPIS)

Sustainable agriculture /

BSE/GAP/GMP

Feed additives Meat & bone meal Food by-products Botanical impurities Medicated feed

Agricultural contaminants Mycotoxins

Pesticides

Processing contaminants Melamine PAHs

Food & Feed Hygiene, storage

Traceability / Food safety /Toxicology

PETS / animal health care

Anti-fraud / Label compliance Food Quality &

Safety


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Fig. 2 - Public health and animal health protection – Coordinated governmental laboratory activities for assuring feed and food safety (ministry of agriculture and ministry of health)

b Feed safety la Pesticide residues Mycotoxins, GMO, PAPs Heavy metals, PCB, POPs dioxins, microbial cont., etc. (feed mills)

WATER

PLANT PROTECTION INSPECTION SERVICE (PPIS)

VETERINARY SERVICES AND ANIMAL HEALTH (VSAH )

MINISTRY OF HEALTH - The National Food Service

Processed food Pesticide residues, veterinary drug residues, heavy metals, nitrate, food additives, mycotoxins, microbial contamination,etc.

Raw agriculture - )NRCL.(safety labFood produce from animal origin Meat, milk, eggs, edible tissues, honey, etc.

Veterinary drug residues Pesticide residues, mycotoxin, heavy metals, PCB, Hormones etc.

ANIMAL HUSBANDRY

IMPORTED

PRODUCTS

IMPORTED

PRODUCTS

Veterinary medical products

Food & Feed hygiene lab microbial contaminations, etc.

Raw agriculture commodities Industrial by products of plant origin, (feed centers)

Pesticide Residue Analysis

Environmental pollutants

Toxicology Lab

Pathology Lab Dpt.

Environmental pollutants

Pest & Disease diagnosis

Pesticide application Pesticide QC


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2. Current status of the Israeli animal feed market - production and trade

Israel is almost completely dependent on imports to meet its grain and feed needs.

Feed wheat and corn are the main ingredients of feedstuffs used in the local poultry,

dairy, cattle and aquaculture farms in Israel. The Israeli feed milling industry shifts

easily from corn, barley and sorghum to feed wheat, depending on price. Many

Israeli traders consider the Black Sea Basin (BSB) a “natural” source for grains due to

its proximity and the convenience of small shipments. However, whenever there is a

shortage of grains from the BSB, the market share of U.S. grains increases

significantly.

Local Production - Due to continued unfavorable rainfall in most of Israel it is

estimated that domestic wheat production for 2011/12 will not change compared to

previous year production levels, and will total about 100,000 tones. Israel did not

increase its wheat growing area as a result of the global peak in wheat prices.

On the other hand, driven by the significant increase in world prices for corn, corn

production in 2011/12 is estimated to total about 8,000 tons, a 430 percent increase

from the previous year levels.

In the coming decades experts predict difficulties in the ability to produce feedstuffs

due to world population growth and climate change. Therefore, Israel must prepare

for a possible shortage of feed in the next two decades and consider more efficient

recycling of industry byproducts into feed and replacing current agricultural crops

with wheat. In order to overcome the lack in natural resources, particularly rural

land, Israel may have to give up crops like sunflower seeds and cotton in the Iezreel

Valley (North of Israel) in favor of wheat. It is estimated that Israel will be able to

increase its local wheat production by about 50,000 tons.

Local Mixed Grains Market

About 90 percent of the local feed milling industry is controlled by 7 feed

millers. The total market of the Israeli feed milling industry is estimated at 2.3-2.55

million tons of mixed grains per year.


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Feed Miller x1000 tons Share

Ambar 775 35%

Miloubar 575 26%

Zemach 255 12%

Tadmir 210 10%

Asamey Oz 200 9%

Asam Hagalil 110 5%

Kfar Yehoshua 80 4%

Total 2,205 100%

Table 1 - The Largest Feed Millers in Israel, Annual Mixed Grains 2.1 imported feed ingredients to Israel

Imported feed products to Israel regulated today by the Ministry of Agriculture

according Israeli feed law since 1971 and are subject to inspection at the time of

entry. Shipments found not to comply with our laws and regulations are subject to

rejection or detention. They must be brought into compliance; otherwise, they are

subject to refusal.

Due to the ban on grain exports from Russia, combined with Ukraine grain export

quotas; the Israeli feed milling industry is shifting from barley and feed wheat to

corn and sorghum

2010/11 Trade - Total grain imports in 2010/11 is estimated to decrease slightly to

just above 3 million tons, mostly wheat (about 1.5 million tons) and corn

(about 1.25 million tons).

The slight decrease is mainly due to increased local grains stocks combined with

shortage of grains from Ukraine and Russia.

Due to the expected continued low supplies of feed wheat and barley from the

Ukraine and Russia in 2010/11, the local feed milling industry will use corn and

sorghum at the expense of feed wheat and barley.

2011/12 Trade - Total grain imports in 2011/12 is estimated to increase from

about 3 million tons in 2010/11 to about 3.1 million tons in 2011/12, mostly wheat

(about 1.65 million tons) and corn (about 0.9 million tons). The increase is


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mainly in order to rebuild barley and feed wheat stocks combined with increased

supplies of grains from Ukraine and Russia and the U.S.

corn

37%

others

1%

Feed Wheat

24%

corn chips

2%

Gluten feed

& DDGS

7%

all kinds

of meals

8%

Oats

2%

barley

15%

sorghum

4%

Chart 2: Total Import of all Feedstuff to Israel from 1997-2010 (CY), tmt and Market Share

Blood meal

1%

Feather meal

9%

Pet food

55%

Chicken Meal

12%

Feed additives

7%

Edible fish feed

1%Fat

6%

show fish feed

6%

fish meal

3%Rodent feed

0%

Chart 3 - Total Import of all Feedstuff controlled by VSAH to Israel during 2011 , and Market Share


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Quantity (Ton) Product

496 Edible fish feed

5108 show fish feed

46686 Pet food

2160 fish meal

19 Rodent feed

7378 Feather meal

490 Blood meal

10094 Chicken Meal

6161 Feed additives

4760 Fat

83,352 Total (ton)

Table 2 – Imported Feedstuff to Israel during 2011, controlled by VSAH

PPIS procedures for the import of feed for animals:

The following certificates are required for the purpose of releasing the shipment from

the border station:

A) "Request to import feed for animals and its products" (PPIS certificate)

B) Import Data: grain kind, name of the ship, country of origin, name of the importer

and name of the producer;

C) The shipment must be accompanied by a Quality and Health certificates which

were issued by authorized foreign Laboratories. The certificates must contain the

following:

1) Quality Requirements: Including label indicating the name of the product,

percentage of wetness, net weight of the product, whole grains percentage, foreign

material percentage;

2) Health Requirements: According to the National Maximum Residue Limits. This list

is based whenever appropriate on the Codex Alimentarius limits. The health

certificate should include the following data: level of pesticides, fungicides, steaming

material, toxic elements , and radio activate radiation.

D) Certificate of origin;

E) Importer Statement if the feed for animals is contains GMOs;


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F) Importer statement that he or someone on his behalf has a warehouse for the

purpose of storage.

The quarantine inspector will check the shipment and the accompanied certificates at

the port of entrance, and supposed to test for aflatoxins . In addition, the inspector

will send a sample of the shipment to the Plant Protection and Inspection Services

(PPIS) laboratory for further examination. The shipment will be released after the

inspector finishes all his tests. In case of missing certificates or unsuccessful test

result, the shipment will be held back at the port for further assessment.

2.1.1 Domestic animals feedstuffs

Israel is dependent on imports for its grain and feed needs. Total food and feed

grain imports in CY 2005 amounted to close to 4.2 million mt, of which 2.88 (69

percent) million mt were feed and milling grains and the remainder was soybeans,

gluten, meals, oats and other substitutes. The U.S. market share in CY 2005 totaled

22 percent compared to 52 percent market share in CY 2002. In recent years, the

American market share is affected by increased imports of grain, and soybeans from

Argentina, Brazil and Black Sea Basin.

Product Category Major

Supply Source

Strengths of Key Supply

Countries

Advantages and

Disadvantages of Local Suppliers

Cereals Net Imports: $566.1 Million

1. Black Sea Basin 2. Argentina & Brazil 3. U.S. – 20%

The U.S. has been effected by a variety of high quality grain suppliers to Israel and high price gap between U.S. grains and other grains.

Israel is dependent on imports for its grain and feed needs

Oil seeds, grains, fruits, industrial and medical plants. Straw and feed

Net Imports: $280.7 Million

1. Argentina & Brazil 2. U.S. – 21%

The U.S. hasbeen effected by increased imports of soybeans from Argentina and Brazil. U.S. strength is in gluten and corn chips.

Israel is dependent on imports for its grain and feed needs

Products of milling industry; malt and starches; wheat Gluten Net Imports: $135 Million

US

Table 3 – Major Imports Products Categories and Market Share (GAIN Report -

IS6001)


- 22 -

2.1.2 Food producing animals / Feed consumers / self producers

Feeds used on the farm which are not imported or go through a merkaz mazon (feed

center) as legumes, alfalfa, cowpeas and bakya (vetch). These are potentially

sources for contamination mainly with pesticides, mycotoxins or environmental

contaminants; these are also known sources of reproductive disrupting compounds.

Similarly, the industrial wastes such as molasses, wine sediment, fruit juices and

whey or milk Serum that are delivered directly to farm and could create risk to

animal and public health. The VSAH feed safety inspection system need some sort of

system for certifying and testing feeds used by individual farms. The database listed

below is very valuable and helpful in risk analysis and sampling plan intend for the

VSAH feed safety program.

No. of FARMS FARM CATEGORY

991 Dairy Farms **

165 sheep Farms

3100 Egg- laying Hens Farms *

38 Fish Farms

15 Swine Farms

770 Poultry farms *

52 Goat Farms

160 cattle Farms

Egg and Poultry producers *

No. of FARMS Produce

650 Broilers

120 Turkey

3100 Eggs

150 Reproductive eggs

Dairy Farming in Israel **

811 Family farms (Moshav)

165 Cooperative farms (Kibbutz)

15 Agric. school farms


- 23 -


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- 27 -


- 28 -


- 29 -


- 30 -

2.1.3 Pet food

The VSAH import/ export inspection service annual report 2011 inform that israel

imported about 50,000 tons pet foods every year. If we add on that the local

production of pet food than we have a local pet food market size of around 100,000

tons. The Main local pet food producer is Bio-Pet; a member of the Maabarot Group.

Bio-Pet own 28% of the pet food market in Israel. Bio-Pet is the leading pet

food company in Israel with a Strong distribution network in the Israeli market:

supermarket chains, private chain stores, pet shops, and professional market. The

company products reach 400 pet shops, and 1,000 breeders.


- 31 -

The inspection and acceptance of imported pet foods to Israel is mainly based on

certifications and microbiological tests of the imported products.

Pet food and pet care products in Israel show positive growth rates in recent years.

The strongest trend in the pet food market has been in the premium and super-

premium products. Imported products account for 50% of value sales. The number

of Israeli households that have a pet is expected to grow. Awareness of pets' health

and their well-being is steadily increasing in Israel and will lead to a higher volume of

sales of pet foods, mainly the premium brands and pet care products.

The vast majority of pet food is distributed by non-grocery retailers – mainly pet

shops and pet superstores – as consumers seek convenience, discounts and

recommendations. During 2009, a new concept was seen in the non-grocery

channel: pet mega stores. This new concept is based around size and products

diversity.The outlook seems secure for pet care in Israel. Consumers will continue to

turn to higher quality foods for their pets, with more pet owners purchasing premium

brands. Due to the heavy competition amongst retailers, there is expected to be

positive though slightly slower value growth within the market, as price wars are

expected to continue to drive market volume. As the result of pet foods being

marketed which contained toxic compounds which killed dogs and cats, there is a

demand for higher food safety inspection of pet food in Israel.

) VSAH/ 2011 (Imported pet food

Shipments Country )Ton(ty Quanti

8 Canada 1173

1 Spain 57

19 USA 4845

9 China 148

1 Brazil 157

16 Australia 1442

17 France 3904

10 Germany 9495

1 India 2

31 Italy 25209

1 Thailand 6

13 England 792

3 Taiwan 36

130 -Total - 47266

Table 4 – Imported Pet food to Israel during 2011, VSAH –Import/Export


- 32 -

Pet food impot to Israel (2011)

Germany

21%

Taiwan

0%

India

0%

Italy

54%

Thailand

0%

England

2%

China

0%

Australia

3%

France

8%

Canada

2% Spain

0%USA

10%

Brazil

0%

Chart 4 - Annual Import of Pet foods to Israel 2011 (source -VSAH import/export)

In the European Union, pet food is regulated by the same harmonized standards

across the EU, via the Feeding Stuffs Act. There is no legislation in the EU written

specifically for pet foods. The legislation which is relevant to pet foods is produced

for other purposes - mainly livestock feed - but includes provisions for pet foods.

All ingredients used for pet food have to be fit for human consumption according to

EU requirements. But regulations require that pet food that contains by-products be

labeled as "Not for human consumption" even though such by-products have to be

derived from animals declared fit for human consumption. Raw pet food has to be

labeled "Pet food only".

Products meant for daily feeding are labeled "complete pet food". Products meant for

intermittent feeding are labeled "complementary pet food" while products with an

ash content of over 40% are labeled "Mineral Feeding stuff". Ingredients are listed in

descending order by weight.

The use of additives is strictly controlled within the EU, with only those identified on

an approved list being permitted for use. The term "additive" has a definition; There


- 33 -

are five principle groups of additives: technological additives, nutritional additives,

sensory additives, zootechnical additives and coccidiostats and histomonostats.

Each of these groups is further divided into subgroups. For example, the group of

technological additives contains permitted preservatives, antioxidants, etc., whereas

the sensory group contains colorants and flavorings and the nutritional group

includes vitamins and trace elements. A full list of the subgroups is given in Annex I

of the new regulation.

Many of the permitted additives also have a number of restrictions relating to their

use; often being limited to a maximum permitted level, to a particular

species or life stage. Of particular note is the group "zootechnical additives,"

which lists the permitted prebiotics and probiotics, again limited to particular

identified species. To date, there are no prebiotics which are permitted for use in

petfoods, and the first probiotics have just been permitted for a provisional period of

four years for use in dog and cat foods only.

Plants manufacturing petfoods in the EU need to be "approved" or "registered" with

their national authorities under two different pieces of legislation. If they are using

Category 3 material of animal origin (EU regulation divides all animal materials not

intended for human consumption into three categories: Category 1, Category 2 and

Category 3. Only material classified as Category 3 is permitted for use in the

manufacture of petfoods or any other animal feedingstuff)., they must be approved

by the veterinary authorities. Following a compliance inspection against the

requirements identified in 1774/2002, a veterinary approval number will be given.

Secondly, and quite separately, if the plant is using any of the additives

vitamin A, vitamin D, copper or selenium (in the form of premixes), then

they must be inspected and "registered" by their local authority for compliance with

Directive 95/69. If these nutrients are being added as individual substances, then the

plant needs to be "approved" rather than "registered." This directive is all about

suitability of machinery and systems for the use and control of particular substances.

This "registration" or "approval" number must be printed on all individual retail

packs.

In addition to the various regulations and directives identified above, many of the

petfood manufacturers' trade associations throughout Europe who are affiliated to


- 34 -

the European petfood manufacturers' association (FEDIAF), have their own "Codes of

Practice" and guidelines. Several of these have the support of the enforcement

authorities in their respective countries and, as such, have some legal standing.

In the United States, there has been extensive media coverage of the pet foods

recall. There has been widespread public outrage and calls for government

regulation of pet foods, Within the FDA, the Center for Veterinary Medicine (CVM)

has primary responsibility for enforcing the Act to ensure that animal foods, including

pet foods, are safe and labeled appropriately. There is no requirement that pet foods

have pre-market approval by FDA. The Federal Food, Drug, and Cosmetic Act

(FFDCA) require pet foods be:

• Safe to eat

• produced under sanitary conditions

• Free of harmful substances

• Truthfully labeled

– Canned pet foods: free of viable

microorganisms

• No pre-market approval requirement

• Labeling regulations:

• Identification of the product

• Net quantity statement

• Name & place of business

• listing of all ingredients most to least by wt

• Ingredient standards & definitions

FDA also plays an active role in pet food regulation in partnership with the

Association of American Feed Control Officials (AAFCO). The AAFCO has more

detailed regulations for pet food labeling than the Federal regulations. In US,

Most States adopt the AAFCO guidelines. A series of recent recalls in the US for

high aflatoxin levels in pet food is increasing the pressure to tighten government

food safety rules.


- 35 -

Fig. 3 - flow chart of public and authorities response to feed contamination

2.2 Feed mill plants

The feed mills (FM) in Israel ( 24 feed mills ) produces animal-feed for all kind of

domestic animals in several sectors, including broilers, turkeys, breeders, layers,

dairy herds, calves, sheep and fish. Beside the standard production line and basic

products , the big feed mills (6 FM) are capable of complying with specific demands

from customers in everything pertaining to feed composition for specific

requirements.

The mission is to serve all sectors of the livestock economy by supplying the

optimum kinds of feed in terms of economic feasibility and nutrition. To provide

response to each sector or individual farmer requirements, operating according to

strict biosecurity regulations.

Each feed mill laboratory has a necessary equipment to meet the QC/QA needs of

the product and the customer. The lab is working closely with the nutrition


- 36 -

department or the nutritionist in the small feed mills. Most of feed mills are backed

by a dedicated and experienced technical stuff.

Some of the feed mills as AMBAR AND ASAMI OZ found it important for them to

produce their own premixes from secure sources, in aim to ensure better quality and

reliability.

production tons/year

Feed mill

800000 AMBAR

600000 MILOBAR

220000 TADMIR

220000 TZEMACH

200000 ASAMEY OZ

150000 AMIR DAGAN

100000 ASAM HAGALIL

100000 BAR-ON

60000 NAHALAL

60000 KFAR JOSUAH

60000 GDEROT

35000 RAMAT TZVI

30000 MOLEDET

30000 YONI -KFAR HAROE

30000 RAFAEL ILAN

30000 RAMOT HASHAVIM

25000 KFAR VITKIN

25000 MILUOT - RANAN

20000 EIN VERED

15000 YAVNE

10000 EIN HANATZIV

4000 YPHAT

4000 HEMED

3000 HERUT

2831000 Total

Table 5 –Feed mill plants in Israel


- 37 -

BAR-MAGEN

FIBRO-KOFFOLK

ASAMEY OZ

AMBAR

Table 6 –Feed additives and premixes producers


- 38 -

2.3 Merkaz Mazon (Feeding centers)

Feed Centers manufacture and supply T.M.R. (Total Mixed Ration) for all branches of

ruminants - dairy cows, dry cows, beef cattle, heifers, goats and sheep. In Israel we

have about 18 feed centers.

Feed is a significant cost in milk production. Generally over 50 percent of the

production cost may be associated with meeting the nutritional requirements of the

lactating cow. Dairies monitor feed cost through feed ingredient purchases, feed

delivery records and weigh backs of refused feed. However, actual costs

associated with shrink or contaminated feedstuffs are often ignored.

Contaminated feed can affect the animal health and production in terms of yield

reduction as well as damage to milk quality and safety. Shrinkage is the loss of feed

ingredients that never have a potential for economic return. Generally, shrinkage

includes not only storage losses but excessive addition rates in rations that are

unnecessary to meet the nutritional needs of the animal.

An efficient and effective feed storage and handling system is vital to any modern

dairy farm. The feed center can be considered the center of the entire feeding

system like the hub or a feed production wheel. From the feed center, feed is carried

out the spokes of the wheel to the animals. Harvested crops food industry by

products and off-farm feedstuffs are hauled back to the feed center. In modern dairy

design, the feed center should operate as a separate entity. It should have its own

location, traffic patterns, and management system. However, it can not be isolated

from the rest of the dairy design. Decisions made in feed center design will influence

the housing design and vice versa. For example, operation of the feeding system

should not interfere with or depend on the flow of animals to and from the parlor. In

Israel there are ~ 18 feed centers (see map) most of them are not routinely

inspected for food safety measurements and the criteria parameters in this section of

the Israeli feed market are not solid or clear yet. The new feed law should address

the problems and needs within this sector in aim to improve mainly the feed safety

issue.


- 39 -

Fig. 4 –. Feed center materials flow chart, will allow the feed storage and handling to be defined and changed as needed on paper. All feedstuffs, storages, and transport methods should be outlined.

production tons/year Feeding center

500,000 Total 6 Feed Centers

AMBAR

50,000 AMBAR -1

50,000 AMBAR -2

50,000 AMBAR -3

50,000 AMBAR -4

50,000 AMBAR -5

250,000 AMBAR -6

200,000 KFAR MACABI

40,000 KFAR YEHOSHUA

65,000 NAHALAL

50,000 KFAR VITKIN

50,000 AMATZ

40,000 MIDRACH OZ

150,000 ~500 Tons/day

YATZIV

100,000 YAVNE

40,000 H.G.I Feeding center

50,000 YONATAN-TZEMACH

30,000 BAIT ITZHAK

575000 Total

Table 7 – Feeding centers in Israel, annual production


- 40 -


- 41 -

2.4 Recycling of chicken manure and processed animal waste

Chicken manure is an important feed component in the Israeli beef cattle as well as

a fertilizer in horticulture provides a rich growing medium and a good source of

nitrogen for plants, mainly in organic agriculture.

About 65,000 ton are used as feed ingredient for cattle and 105,000 ton used

as composting ingredients generated on the poultry farms and bedding or used

directly without composting process, as a fertilizer in horticulture.

Recycled animal waste, such as processed chicken manure and litter, has been used

as a feed ingredient for almost 40 years. This animal waste contains large amounts

of protein, fiber, and minerals, and has been deliberately mixed into animal feed for

these nutrients. chicken manure is used in Israel by small farmers and owners of

beef but not in dairy herds.

While the practice of feeding animal waste to animals seems unpleasant, the use of

this product is safe as long as it meets certain specifications required by the VSAH as

low levels of cocxidistates and no botulinum toxin. . Association of American

Feed Control Officials (AAFCO). AAFCO includes officials from all States and the

Federal government who are responsible for enforcing the laws regulating the

production, labeling, distribution, and/or sale of animal feeds. One of AAFCO's main

goals is to provide a mechanism for developing and implementing uniform and

equitable laws, regulations, standards, definitions, and enforcement policies for

animal feeds. AAFCO has established "Standard Names and Definitions" for three

processed waste products as follows:

• Dried Poultry Waste-(DPW) — a processed animal waste product composed

primarily of feces from commercial poultry, which has been thermally

dehydrated to a moisture content not in excess of 15.0%. It must contain not

less than 18.0% crude protein, and not more than 15.0% crude fiber, 30.0%

ash, and 1.0% feathers.

• Dried Poultry Waste-NPN Extracted — a processed animal waste product

composed primarily of feces from commercial poultry which has been

processed to remove part or all of the equivalent crude protein, NPN as urea

and/or uric acid and which has been thermally dehydrated to a moisture

content not in excess of 15.0%. It must contain not less than 11.0% crude

protein, and not more than 15.0% crude fiber, 30.0% ash, and 1.0%

feathers.


- 42 -

• Dried Poultry Litter-(DPL) — a processed animal waste product composed of

a processed combination of feces from commercial poultry together with litter

that was present in the floor production of poultry, which has been artificially

dehydrated to a moisture content not in excess of 15.0%. It must contain not

less than 18.0% crude protein, and not more than 25.0% crude fiber, 20.0%

ash, and 4.0% feathers.

AAFCO specifications require that processed animal waste products not

contain extraneous materials such as, but not limited to, metal, glass, nails

or other harmful matter. They must be free of harmful pathogenic

organisms, pesticide residues, parasites, or drug residues, above levels

permitted by State or Federal statute or regulation, which could be harmful to

animals or could result in residues in human food products or by-products of animals

at levels in excess of those allowed by State or Federal statute or regulation.

Products which do not meet the AAFCO definition could be considered adulterated

and are subject to State regulatory action. Each individual State has jurisdiction for

the surveillance and regulation of processed animal waste as an animal feed

ingredient. Products not complying with the AAFCO requirements and found in

interstate commerce could be considered adulterated and subject to Federal

regulatory action.

AAFCO requires that any person registering any processed animal waste product

test, by representative sampling and assaying of such samples, and keep accurate

records of the processed animal waste product.

The registrant, manufacturer, or producer of processed animal waste product

ingredients must conform to the following sample and assay requirements, in

addition to quality standards, testing on the same production run of lots:

a. Drugs suspected or known to be used in the feed or as a therapeutic treatment

of source animals.

b. Pesticides used on the source animal, facility, and wastes for pest control.

c. Pathogenic organisms, at least to include Salmonella and E. Coli.

d. Toxic elements: arsenic, cadmium, copper, lead, mercury, and selenium, at least.

e. Parasitic larva or ova.

f. Mycotoxins, such as aflatoxin.

Periodic analyses must be conducted on production runs. Any processed animal

waste product that does not meet the quality standards for the product must be


- 43 -

further processed until standards are met, or must be diverted to non-feed uses or

destroyed.

If a product contains drug residues, at low risk to cattle, then the label must contain

the following statement in bold face type:

"WARNING: THIS PRODUCT CONTAINS DRUG RESIDUES. DO NOT USE WITHIN 15 DAYS OF

SLAUGHTER AND DO NOT USE 15 DAYS PRIOR TO OR DURING THE FOOD PRODUCTION

PERIOD OF DAIRY ANIMALS AND LAYING HENS."

If the product contains 25 ppm or greater of copper, a maximum guarantee of

copper and the following statement in bold face type is required:

"WARNING: CONTAINS HIGH LEVELS OF COPPER: DO NOT FEED TO SHEEP."

Any person seeking register processed animal waste products also must keep

accurate records of:

1. All sources of raw materials and date acquired, including information on drug

and pesticide usage.

2. All production output, including a code or other method to identify the date of

production.

3. All sales and distribution, including the name and address of the purchaser or

to whom distributed, date, quantity and product code.

4. Sample and assay records of testing.

Poultry litter is an acceptable source of protein for beef cattle, and it is typically

inexpensive relative to other high-protein feedstuffs. Rations containing poultry litter

should be carefully balanced to ensure that nutritional requirements of cattle are met

and that the potential for mineral excesses is minimized. Proper processing and

storage to inhibit growth of pathogenic organisms and prevent incorporation of

pharmaceutical residues are essential to ensure that poultry litter is a safe and high-

quality feed for beef cattle using adequately processed animal waste in animal feed

may not be esthetically pleasing but it is safe, nutritionally valid, and environmentally

sound.


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3. Feed safety - Major hazards in animal feed and feed ingredients related

to animal and public health

Extensive lists of hazards related to feed and food safety that can potentially be

present in feed were reviewed, and the following criteria to help select hazards of

current importance in feed were developed:

(1) relevance of the hazard to public health

(2) extent of the occurrence of the hazard

(3) impact of the hazard on international trade in food and feed.

The following feeds and feed ingredients were considered:

• compound/complete feeds;

• Grains and oilseeds (whole and meals), fruit and vegetable by-products, including

oils;

• forage, including grasses, hay and silage;

• Directly dried products (e.g. bakery by-products);

• Bio-fuel by-products (e.g. distillers’ grains with solubles (DGS), dried distillers’

Grains with solubles (DDGS) and glycerol);

• Food processing by-products and co-products;

• Minerals, including trace elements, and binders;

• Animal by-products, including meat and bone meal and fats;

• Aquatic products, including fishmeal, shellfish, fish by-products, seaweed and krill;

• Fermentation/biomass and dried products;

• Viable microbes;

• Silage additives

3.1 Selection and regulation of undesirable substances of concern in feed

The list of potential hazards or undesirable substances is very large and constantly

evolving. A multidisciplinary approach to risk assessment and risk management is

needed.

The twinning project is suitable approaches as bilateral institute-to-institute or

country-to-country arrangements, to meet international standards through the

provision of technical advice and assistance.

The EU Directive (2002/32/EC) is intended to control undesirable substances which

can occur naturally in feedstuffs, such as toxic elements, dioxins, toxic weed seeds,


- 45 -

mycotoxins, etc. Since it is impossible to eliminate most of these substances from

feedstuffs, maximum permitted levels are fixed at a level which prevents adverse

effects on animal or consumer health. The Regulation applies to all feeds fed to all

animals, including pets and animals in the wild.

Where a feedingstuff contains an undesirable substance in excess of the maximum

permitted level, it must be removed from the food chain.

The Regulation also introduces a provision designed to reduce or eliminate certain

sources of contamination. When the background level for an undesirable substance

is exceeded Member States are required to investigate the cause of the

contamination and take appropriate action.

The FDA has the responsibility to enforce the Federal Food, Drug, and Cosmetic Act

(FFDCA) and to ensure that foods for man and animal are safe. Within FDA, CVM is

responsible for protecting the animal feed supply and ensuring that it is safe and

wholesome, and that the incidence of harmful residues in human food derived from

animals is minimized. This program is designed to address this responsibility as it

relates to all contaminants, except drug residues and BSE matters.

Animal feeds can be adulterated with pesticides, industrial chemicals, dioxins,

elements, mycotoxins, and microbes. They may present a hazard to livestock health

and production, and to the public health by residues in animal-derived human food

or by their ability to cause disease. Many of the more frequently identified

contaminants in animal feeds are toxic, carcinogenic, mutagenic, teratogenic, or

otherwise deleterious to animal and human health.

The FDA/ CVM Feed Contaminants Program (FCP) provides guidance for:

A. Collection of animal feed samples and analysis for pesticides, industrial chemicals,

dioxins, elements, mycotoxins and microbes.

B. Surveillance of the feed industry to identify potential problem areas and additional

sampling of these problem areas to ensure compliance.

C. Investigation of violative findings.

The VSAH organization in Israel is going to enforce the new Israeli feed law, the

new regulations are contain, as undesirable substances, a list of pesticides ,

mycotoxins and microelemnts that has to be check on routine base

The following undesirable substances found as being currently most important

based on Safety assessment and detection of hazards in animal feed and feed

ingredients related to public health:


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3.2 Microelements (toxic elements)

Microelements or Heavy metals are present in all foodstuffs. Their amount in food

and feed depends on the natural content and on the conditions under which food

and feed are produced and processed. Some elements have nutritional functions and

are essential to the health. But others such as lead, cadmium and mercury have no

nutritional relevance and can cause serious illnesses.

To reduce the risk to human health associated with high heavy metal content in food

and feed, maximum allowed limits in several commodities have been laid down. The

food and feed safety inspection systems acts in this frame of legislation dealing with

controls of heavy metal content in food and feed as a result of environmental or

industrial contamination.

Total concentration of trace elements does not always provide adequate information

on bioavailability and toxicity. Speciation analysis is required

HPLC- and GC-ICP MS are versatile tools for trace element speciation analysis

Methods for Arsenic speciation analysis by HPLC-ICPMS in feed already developed.

inorganic arsenic is the most toxic form

Arsenic Alternatively can be analyse by SPE-HG-AAS

1/3 of arsenic in the feed is lipid-bound!

Other heavy metal which interests us with respect to feed safety is mercury.

Mercury exists in the environment as elemental mercury (metallic), inorganic

mercury and organic mercury (primarily methyl mercury).

Mercury speciation

•Effects the central nerve system

•Learning ability for children

•Bioaccumulation in the food chain

•Toxicity: MeHg > inorganic Hg

•Biomethylation:

Inorganic Hg -> MeHg

Sea water

0,005 ppb

(2% MeHg)

Plankton/algae

11 ppb

(25% MeHg)

Zooplankton

11 ppb

(25% MeHg)

Fish

40 ppb

(90% MeHg)

Mercury speciation





•Biomethylation:


Sea water

0,005 ppb

(2% MeHg)

Plankton/algae

11 ppb

(25% MeHg)

Zooplankton

11 ppb

(25% MeHg)

Fish

40 ppb

(90% MeHg)

Mercury speciation





•Biomethylation:


Sea water

0,005 ppb

(2% MeHg)

Plankton/algae

11 ppb

(25% MeHg)

Zooplankton

11 ppb

(25% MeHg)

Fish

40 ppb

(90% MeHg)





•Biomethylation:


Sea water

0,005 ppb

(2% MeHg)

Plankton/algae

11 ppb

(25% MeHg)

Zooplankton

11 ppb

(25% MeHg)

Fish

40 ppb

(90% MeHg)

Sea water

0,005 ppb

(2% MeHg)

Plankton/algae

11 ppb

(25% MeHg)

Zooplankton

11 ppb

(25% MeHg)

Fish

40 ppb

(90% MeHg)

Fig. 5 – Methyl mercury accumulation in fish tissues – potential risk in fish mill


- 47 -

The toxicity and toxicokinetics of mercury in animals and humans depends on its

chemical form. Among organic forms, the most toxic is methylmercury. Indeed

methylmercury is recognised as significantly more toxic than inorganic mercury and

therefore the determination of total mercury in feed may not always accurately

reflect the risk posed by the organic forms.

Methylmecury is able to cross the blood-brain and the placental barriers. As a

consequence, the nervous system is the primary site of toxicity in animals and

humans. In humans, effects on neurological development have been observed in

children of mothers orally exposed to methylmercury.

Methylmercury bioaccumulates and biomagnifies along the food chain particularly in

the aquatic food chain; long-lived carnivorous fish and marine mammals exhibiting

the highest content.

Mercury speciation can also be analyse by GC-ICPMS/HCLP-ICPMS

Cereals .Fish oil and fish meal are potential sources of exposure in feedstuffs

Mercury Alternatively can be analyse by SPE-HG-AAS

)Israel( in animal feed toxic elementsMaximum levels for

Mercury (Hg) 100 ppb

Lead (Pb) 1000 ppb - in all feedstuffs

15,000 ppb - in phosphate feed additives

Arsenic (As) 2000 ppb - in all feedstuffs

10,000 ppb - in phosphate feed additives

Cadmium (Cd)

500 ppb - in all feedstuffs 10,000 ppb - in phosphate feed additives


- 48 -

Micro-elements Annex I to EU Directive 2002/32/EC 6.12.2005

Maximum content in

mg/ kg (ppm)

Feed materials with the exception of: 10

– green fodder (such as hay, silage, fresh grass, etc.)

30

– phosphates and calcareous marine algae 15

– calcium carbonate 20

– yeasts 5

Additives belonging to the functional group of compounds

of trace elements except: 100

– zinc oxide 400

– manganous oxide, iron carbonate, copper carbonate

200

Additives belonging to the functional groups of binders and

anti-caking agents except: 30

– clinoptilolite of volcanic origin 60

Premixtures 200

Complementary feedstuffs with the exception of 10

– mineral feedstuffs 15

Complete feedstuffs 5

Lead (*)


– feedstuffs of animal origin with the exception of marine

crustaceans such as marine krill 500

– marine crustaceans such as marine krill 3000

– phosphates 2000

– calcium carbonate 350

– magnesium oxide 600

– calcareaous marine algae 1000

Vermiculite (E 561) 3000

Fluorine (*)


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Complementary feedstuffs

– containing ≤ 4 % phosphorus 500

– containing > 4 % phosphorus 125 per 1 % phosphorus

Complete feedstuffs with the exception of 150

– complete feedstuffs for cattle sheep and goats

– – in lactation 30

– – other 50

– complete feedstuffs for pigs 100

– complete feedstuffs for poultry 350

– complete feedstuffs for chicks 250

Feed materials of vegetable origin 1

Feed materials of animal origin 2

Feed materials of mineral origin except 2

– phosphates 10

Additives belonging to the functional group of compounds

of trace elements except 10

– copper oxide, manganous oxide, zinc oxide and

manganous sulphate monohydrate 30

Additives belonging to the functional groups of binders and

anti-caking agents 2

Premixtures 15

Mineral feedstuffs

– containing < 7 % phosphorus 5

– containing ≥ 7 % phosphorus , 0,75 per 1 % phosphorus

with a maximum of

7,5

Complementary feedstuffs for pet animals 2

Cadmium (*)

Other complementary feedstuffs 0,5


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Complete feedstuffs for cattle, sheep and goats and

feedstuffs for fish except 1

– complete feedstuffs for pets 2

– complete feedstuffs for calves, lambs and kids and other

complete feedstuffs 0,5

Feed materials with the exception of: 0,1

— feedstuffs produced by the processing of fish or other

0,5

marine animals

— calcium carbonate 0,3

Complete feedstuffs with the exception of: 0,1

— complete feedstuffs for dogs and cats 0,4

Complementary feedstuffs except 0,2

— complementary feedstuffs for dogs and cats 0,3

— mineral feed, 0,2

Mercury

— compound feedstuffs for fish, 0,2


— meal made from grass, from dried lucerne and from dried clover,

and dried sugar beet pulp and dried molasses sugar beet pulp

4

— palm kernel expeller 4

— phosphates and calcareous marine algae 10

— calcium carbonate 15

— magnesium oxide 20

— feedstuffs obtained from the processing of fish or other marine

animals 15

— seaweed meal and feed materials derived from seaweed

40

Complete feedstuffs with the exception of: 2

— complete feedstuffs for fish and complete feedstuffs for fur

animals 6

Complementary feedstuffs with the exception of: 4

Arsenic

— mineral feedstuffs 12


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Lead + Arsenic (*)Maximum levels refer to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

Fluorine (*)(*) Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that theused extraction procedure has an equal extraction efficiency.

3.3 Mycotoxins

The risk of contamination by mycotoxins is an important food safety concern for

grains and other field crops. Mycotoxins are toxic byproducts of mold infestations

affecting as much as one-quarter of global food and feed crop output.

Mycotoxins are produced by fungi of various genera when they grow on agricultural

products before or after harvest or during transportation or storage. Both intrinsic

and extrinsic factors influence fungal growth and mycotoxin production on a given

substrate. The intrinsic factors include water activity, pH, and redox potential

whereas extrinsic factors which influence mycotoxin production are relative humidity,

temperature and availability of oxygen.

Many mycotoxins, with different chemical structures and biological activities, have

been identified. They may be carcinogenic (e.g. aflatoxin B1, ochratoxin A,

fumonisin B1), oestrogenic (zearalenone), neurotoxic (fumonisin B1),

nephrotoxic (ochratoxins, citrinin, oosporeine), dermonecrotic (trichothecenes)

or immuno-suppressive (aflatoxin B1, ochratoxin A, and T-2 toxin). Much of the

published information on toxicity concerns studies in experimental animals and these

may not reflect their effects in humans and other animals. Mycotoxins are regularly

found in feed ingredients such as maize, sorghum grain, barley, wheat, rice meal,

cottonseed meal, groundnuts and other legumes. Most are relatively stable

compounds and are not destroyed by processing of feed and may even be

concentrated in screenings.

● One study estimated that crop losses (corn, wheat, and peanuts) from mycotoxin

contamination in the United States amount to $932 million annually, in addition to

losses averaging $466 million annually from regulatory enforcement, testing, and

other quality control measures (CAST, 2003).


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● Wilson and Otsuki (2001) estimated that, for a group of 46 countries—including

the United States—the a

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