ระบบการตามสอบสิ นค้าเกษตรและอาหาร
ในประเทศคู่คา้
พรพรหม ชัยฤทธิไชย
ผู้อำนวยกำร
ศูนย์สำรสนเทศ สำนักงำนมำตรฐำนสินค้ ำเกษตรและอำหำรแห่งชำติ
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Main topics
• ควำมสำคัญของระบบตำมสอบสินค้ ำเกษตรและอำหำร
• มำตรฐำนกฎระเบียบของประเทศคูค่ ้ ำ
– ระบบกำรตำมสอบในยุโรป
– ระบบกำรตำมสอบในสหรัฐ
• ควำมก้ ำวหน้ ำกำรตำมสอบของไทย
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ความสาคัญ
ของระบบตามสอบสิ นค้าเกษตรและอาหาร
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Frequent outbreak
Economic loss
Trade requirement
PL law
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ห่วงโซ่มีความซับซ้อน มีผเู ้ กี่ยวข้องจานวนมาก ตามสอบและแก้ไขยาก
Farmers
Consumers
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Farmers
trader1
trader2
Consumers
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
pig
transport
Pizza
T
Pig
carcass
T
sausages
distributor
Carcass portion
T
T
T
Sausages
retailer
T
Portion
mince
mince
T
consumer
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Farmers
Farmers
trader
Consumers
Farmers
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Farmers
trader
Farmers
trader
Farmers
trader
Consumers
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ประเด็นความเชื่อมโยงของข้อมูล
pig
transport
Pizza
T
Pig
carcass
T
sausages
distributor
Carcass portion
T
T
T
Sausages
retailer
T
Portion
mince
mince
T
consumer
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ประเด็นประสิ ทธิภาพของระบบ
pig
transport
Pizza
T
Pig
carcass
T
sausages
distributor
Carcass portion
T
T
T
Sausages
retailer
T
Portion
mince
mince
T
consumer
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Traceability center
pig
transport
Pizza
T
Pig
carcass
T
sausages
distributor
Carcass portion
T
T
T
Sausages
retailer
T
Portion
mince
mince
T
consumer
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ประเด็นความร่ วมมือในห่วงโซ่
pig
transport
Pizza
T
Pig
carcass
T
sausages
distributor
Carcass portion
T
T
T
Sausages
retailer
T
Portion
mince
mince
T
consumer
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ประโยชน์
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สืบหำสำเหตุได้ รวดเร็ว
จำกัดขอบเขตของปั ญหำ
แก้ ไขปั ญหำได้ ตรงจุด
ป้องกันไม่ให้ เกิดขึ ้นได้ อีก
สร้ ำงควำมโปร่งใส ผู้บริโภคมัน่ ใจในระบบควำมปลอดภัย
ลดผลกระทบ
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
อะไรคือสิ่ งที่ตอ้ งการ
• ประสิทธิภำพของระบบ
• ระบบกฎหมำยที่รัดกุม
• ควำมร่วมมือของทุกหน่วยในห่วงโซ่
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
การตามสอบในสหภาพยุโรป
• White paper
http://eur-lex.europa.eu/LexUriServ/site/en/com/1999/com1999_0719en01.pdf
• General Food Law
http://eur-lex.europa.eu/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf
• Traceability implementation
http://ec.europa.eu/food/animal/diseases/traces/what_is/index_en.htm
http://www.trace.eu.org/menu/project/
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
White paper
Para 10, Chap 2
Principles of Food Safety
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
The EU White Paper on Food Safety introduced
proposals “ to transform EU food policy into a
proactive, dynamic, coherent and
comprehensive instrument to ensure a high
level of human health and consumer
protection ”. “ A successful food policy
demands the traceability of feed and food and
their ingredients ”.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
General Food Law
Regulation 178/2002
http://eur-lex.europa.eu/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
European Regulation
• Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January
2002 laying down the general principles and
requirements of food law, establishing the
European Food Safety Authority and laying
down procedures in matters of food safety
[See amending acts].
•
http://www.southwestfarmer.co.uk/news/farmingnews/4864256.Pig_producers_
welcome_changes_to_European_labelling_rules/
• http://www.food.gov.uk/news/newsarchive/2010/jan/coolresearch
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
178/2002
EU General Food Law
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Article 3 of Regulation 178/2002/EC, the
General Food Law, defines ‘Traceability' as
being the ability to trace and follow a food,
feed, food-producing animal or substance
intended to be, or expected to be
incorporated into a food or feed, through all
stages of production, processing and
distribution.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Traceability is a fundamental requirement of all Quality
Management Systems that require documented procedures
aimed at product identification, from the purchase of the
starting materials throughout the whole production process
and shipment. A sound knowledge of the food chain, feed
included, is needed to identify the critical control points in the
chain and to implement appropriate controls. Traceability as
such does not improve food/feed safety, but establishes the
transparency needed for efficient control measures. All
traceability measures should be part of the quality system of
the food/feed producer and not handled separately
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The general principles of food law under Regulation 178/2002
require all feed and food businesses “ to have in place systems
so that they can identify the supplier of foods, feeds, food
producing animals and to whom they have supplied such
products ”. Since 1 st January 2006, food sector operators
must comply with the provisions of the aforementioned
Regulation:
• The general duty of compliance (Articles 14 and 17),
• Traceability (Article 18), and
• Incident management (Article 19)
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Prior to January 2006, Industry Guidelines on traceability were developed
by the European food and drink industry. These are particularly relevant
for SMEs, which count for the fast majority of the CIAA Membership (more
then 90% of CIAA Members are SMEs).
• Practical industry experiences confirm that the principles of traceability
must be simple and efficient to be able to be met by all operators in the
food chain. Existing requirements, such as the indication of batch
identification (lot numbers), product labelling, or, in the case of animal
derived food, the use of health marking, are all relevant tools.
• The requirement for traceability must rely on the responsibility of each
operator in the food chain. Each operator has to record and archive
relevant information for traceability. A reference which enables a link with
this information must be passed on to the next operator.
• Industry operators have put such systems in place.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
EU Food labelling
• Council Directive 2000/13/EC
• Commission Directive 2001/101/EC of 26
November 2001 regulating the definition of
meat for labelling purpose, where meat is
used as an ingredient in foodstuffs, and by
Directive 2003/89/EC regard indication of the
ingredients present in foodstuffs.
• Under reviewed.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Introducing the proposal, health commissioner
Kyprianou explained "Food labels can have a huge
influence on consumers' purchasing decisions.
Confusing, overloaded or misleading labels can be
more of a hindrance than a help to the consumer.
Today's proposal aims to ensure that food labels
carry the essential information in a clear and legible
way, so that EU citizens are empowered to make
balanced dietary choices".
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Food labels revisited
• One day not so far in the future,
Europeans may be able to buy a loaf of
bread knowing where the flour came
from.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The EU is considering expanding the use of
food labels to show where the product was
farmed. The step follows a Europe-wide
consultation on the issue of food quality.
Farmers, producers and consumers voiced
strong support for greater use of ‘place-offarming’ labels.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Such labels indicate the country of harvest,
not where the product was processed. They
are already mandatory for some foods sold in
the EU, including unprocessed beef, poultry,
fruit, vegetables, eggs, honey, wine and olive
oil.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• In a paper spelling out its position, the
commission says it will take into account the
concerns of processors and retailers, who
worry they will have a hard time tracking
down the origins of ingredients in processed
food.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The EU has some of the most stringent
farming requirements in the world. But many
consumers question the quality of products
from outside the EU, more so in the wake of
several scares involving imported food in
recent years.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• European farmers like the labels because they
add appeal to their products, both in the EU
and in the global marketplace. Many want the
labels to be even more precise, showing the
particular region where the product was
farmed.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The paper also calls for changes to clear up
confusion caused by the proliferation of other
kinds of food labels in the EU. Many countries,
producers and retailers have adopted schemes
that are different from those used by the EU.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The commission wants to abolish the EU label
for identifying and protecting the names of
traditional products. There have been just 20
registrations since the scheme was set up in
1992. They include a traditional Finnish
biscuit, mozzarella cheese produced in the
Italian tradition and certain Belgian beers.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• EU labels referring to a product’s geographical
origin would also be revised. Examples of
products carrying this logo include
Camembert cheese from the Normandy
region of France; prosciutto from Parma, Italy;
Kalamata olive oil from Greece; Scotch beef
from the UK and bratwurst sausage from
Nuremberg, Germany.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Meanwhile, an EU logo for organic foods is
being developed. Starting in 2010, it will be
mandatory for all products sold as organic in
the EU.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Traceability implementation
• EU TR@CES
• Trace project
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
EU TR@CES
• EU TR@CES (TRAde Control and Expert
System) is a trans-European network for
veterinary health which notifies, certifies and
monitors imports, exports and trade in
animals and animal products. (decision
2002/459/EC)
http://ec.europa.eu/food/animal/diseases/traces/what_is/index_en.htm
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Trace project
• Trace project aims to improve the health and well-being of European
citizens by delivering improved traceability of food products. (5 year
project sponsored by the European Commission)
• will provide consumers with added confidence in the authenticity of
European food through complete traceability along entire fork to farm
food chains.
• will develop cost effective analytical methods integrated within sectorspecific and -generic traceability systems that will enable the
determination and the objective verification of the origin of food.
• will focus firstly on mineral water, cereals, honey, meat and chicken but
will have wider applicability to other commodities.
http://www.trace.eu.org/menu/project/
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Overview of the TRACE project
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The TRACE project is a five year research project funded by the European Commission through the Sixth Framework
Programme that aims to deliver traceability systems and methods that will enhance consumer confidence in the authenticity
of European food. It has done this though the development and implementation of improvements in traceability and
verification procedures.
Some of the key outputs of the project are:
Specification prediction models – results of extensive multi-disciplinary scientific research that have linked components in
food with those in its immediate environment.
Fingerprinting procedures that can verify species, variety and production origin
An open source molecular biological database containing information on methods and sequences for use in authenticating
food
A traceability language that allows different traceability systems to communicate with each other
Testing of developed traceability systems within industry
A wikipedia for food traceability
An extensive consumer behaviour study on food traceability
Web-based interactive communication vehicles for dissemination to stakeholders
Over 50 peer reviewed research papers
The establishment of an international network of researchers and stakeholders that are exploiting TRACE technologies
through implementation in the food industry
The project has also provided training in the subject areas to 49 trainees from 10 countries and hosted 12 workshops and 6
international conferences.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Improved food chain traceability as a result of TRACE
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Traceability is the ability to trace the history, application or location of an entity by means of recorded
identifications. For a given process or product, we want to know all raw materials and ingredients that
went into it. For a given raw material or ingredient, we want to know all processes and products that it
went into. In a supply chain with many links, this means recording information in each link and passing it
along with the product. In TRACE, we have developed tools, methods and guidelines to aid in the
recording and passing on of this type of food product information. This includes:
‘Good Traceability Practice' guidelines both for the food industry in general and for specific sectors
Software tools for recording food product information
A standardized language (TraceCore XML) for enabling electronic data interchange between links in the
supply chain for food products
Data dictionaries for various food sectors (naming and meaning of terms)
A common and re-usable framework (TraceFood Framework) encompassing all of the above, a
All these tools and methods have been implemented in pilot chains in the food industry. A dynamic
repository of related knowledge and experiences has been set up (TraceFood Wiki), and industry training
courses and presentation materials have been developed. This presentation gives an overall, non-technical
overview of how food chain traceability has -, or can be improved as a result of these activities and results
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Traceability Systems Development in TRACE L3-1 In the Traceability
Systems Group (TSG) in TRACE, it has been our goal to specify, develop
and test various components of an efficient traceability system for food
products. In this presentation, the final version of several of these tools is
presented. This includes:
• Final version of the ‘Good Traceability Practice' guidelines
• Final version of the tools for data recording and integration
• Final version of the TraceCore XML
• We will also show the application of these components in real life, with
particular emphasis on the final TRACE pilot chain (frozen cod).
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
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Exploitation of traceability outputs after TRACE ? L3-2 This presentation focuses on the TSG products that will live on after
TRACE. The presentation will consist of three main parts: the TraceFood wiki, the foodtraceability website, and the
TraceCore model.
During the last year the TraceFood Framework and GTP have been transformed into the TraceFood wiki. A wiki based tool for
scientific collaboration in food traceability. Our goal with this tool is to provide a hub for cooperation between both
countries and businesses. The content includes: Fundamentals of traceability, both principles and definitions, The good
traceability practice guide, both generic and for certain sectors, tools, including the work on the TraceCore model and
process mapping methods, traceability projects, both national and international, and traceability references. The wiki can be
found at http://www.tracefood.org.
In addition to the TraceFood wiki, we have also developed the foodtraceability website which provides an easier and
interactive approach to traceability. This site is structured around different actors view on traceability and includes
viewpoints from: the consumer, public authorities, quality assurance, supply chain management, operational and IT. Within
each viewpoint we have small introductory flash videos explaining the basics of traceability from the viewpoint of the actor,
the user can also read more in depth information, test the principles in interactive flash games, access relevant training
material and read more about what other actors think of the current actors related to traceability. The website can be found
at http://www.foodtraceability.eu.
A comprehensive XSD Schema, called TraceCore XML (TCX) version2.2, is now finished and finalized. The TCX has been tested
in various scenarios in the entire fork to farm food chain and the tests have verified the usability of the standard. However,
TraceCoreXML adoption has had limited success so far. The group behind TCX has therefore discussed how TCX could get
more momentum in the industry in the future. After the Trace project ends in December 2009 there are no more funds to
further develop, support and maintain the format. It has therefore been important to try to identify commercially driven
processes that can support the further development of the format. The group has now decided that EPCglobal probably is
the best community to approach. Also, in order to be able to map the traceability model behind TraceCore onto more than
only one format (not necessarily only XML), the TCX group has also created an abstract model to represent the TraceCore
data model and traceability model.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Consumers' perception of food traceability in Europe
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The introduction of improved food traceability systems has aimed to restore consumer confidence in food safety and quality,
in part by being able to provide consumers with more information about the origins of foods and food ingredients. However
little is known about consumer attitudes and beliefs associated with traceability, nor their preferences for information
provision. Given the heterogeneity of European consumers, it is not surprising that they have different perceptions and
expectations regarding and understanding the concept of ‘traceability'. Consumers may also perceive traceability differently
for different product types. The present paper is based upon an analysis of focus groups in 12 countries across Europe. It
explains how European consumers understand the traceability of food products as well as their expectations of traceability
for different types of food product (meat and honey have been used as examples). Labelling schemes for these two types of
products are also examined. The results showed that dissimilarities exist in consumers' perceptions of traceability in
different countries. Some dissimilarity also exists between consumers' expectations of traceability and the information they
require. However, labels are still seen as an important way of communicating with consumers, although the participants
claimed that these labels need to be understandable and more easily accessible to facilitate consumer understanding.
Hence, consumer information needs and requirements regarding traceability are investigated. Semi-structured interviews
with consumers in four European countries focused on the need for traceability, the preferred means of communication,
labelling, and bodies held responsible for traceability and dealing with fraud. Furthermore, consumer perceptions regarding
traceability were investigated by means-end-chain laddering. Consumers in four European countries were questioned about
the benefits they associate with traceability related attributes. The benefits consumers associate with traceability are in
terms of health, quality, safety and control, of which the latter was associated with trust and confidence. These benefits
were similarly important in the countries investigated. Cross-national differences were also observed. Importantly, both
quality and safety were shown to be related to traceability in the consumers' minds with quality implying safety. The results
show that traceability may contribute to improving consumer confidence. The most important aspects of traceability which
should be incorporated into communication with consumers are discussed.
Keywords : Consumer, traceability, food quality, food safety, focus groups, laddering interviews, labels
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Traceability in USA
• FDA
• USDA/FSIS
• States, local, tribal food safety agencies and
law enforcement agencies,
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
กฎหมายเกี่ยวกับการตามสอบในสหรัฐ
• Federal Food, Drug, and Cosmetic Act
• the Public Health Security and Bioterrorism Preparedness and Response
Act
– Section 305 (Registration of Food Facilities)
– Section 306 (Establishment and Maintenance of Records)
– Section 307 (Prior Notice of Imported Food Shipments)
http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
• Food Safety Enhancement Act (SEC. 107 Traceability of food)
http://www.govtrack.us/congress/bill.xpd?bill=h111-2749
• Food Safety Modernization Act (SEC. 210 Traceback requirements)
H.R. 875: Food Safety Modernization Act of 2009
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
CFR
• The Code of Federal Regulations (CFR) is the codification of
the general and permanent rules and regulations (sometimes
called administrative law) published in the Federal Register by
the executive departments and agencies of the Federal
Government of the United States. The CFR is published by the
Office of the Federal Register, an agency of the National
Archives and Records Administration (NARA).
• The CFR is divided into 50 titles that represent broad areas
subject to Federal regulation.
• From wikipedia
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
List of regulation titles
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Title 1: General Provisions
Title 2: Grants and Agreements
Title 3: The President
Title 4: Accounts
Title 5: Administrative Personnel
Title 6: Homeland Security
Title 7: Agriculture
Title 8: Aliens and Nationality
Title 9: Animals and Animal Products
Title 10: Energy
Title 11: Federal Elections
Title 12: Banks and Banking
Title 13: Business Credit and Assistance
Title 14: Aeronautics and Space (also known as the Federal Aviation Regulations, administered by the Federal Aviation Administration)
Title 15: Commerce and Foreign Trade
Title 16: Commercial Practices
Title 17: Commodity and Securities Exchanges
Title 18: Conservation of Power and Water Resources
Title 19: Customs Duties
Title 20: Employees' Benefits
Title 21: Food and Drugs (administered by the US Food and Drug Administration and the US Drug Enforcement Administration)
Title 22: Foreign Relations
Title 23: Highways
Title 24: Housing and Urban Development
Title 25: Indians
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
•
•
•
•
•
•
•
•
•
•
•
•
•
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Title 26: Internal Revenue
Title 27: Alcohol, Tobacco Products and Firearms
Title 28: Judicial Administration
Title 29: Labor
Title 30: Mineral Resources
Title 31: Money and Finance: Treasury
Title 32: National Defense
Title 33: Navigation and Navigable Waters
Title 34: Education
Title 35: Reserved (formerly Panama Canal)
Title 36: Parks, Forests, and Public Property
Title 37: Patents, Trademarks, and Copyrights
Title 38: Pensions, Bonuses, and Veterans' Relief
Title 39: Postal Service
Title 40: Protection of Environment (administered by the United States Environmental Protection Agency)
Title 41: Public Contracts and Property Management
Title 42: Public Health
Title 43: Public Lands: Interior
Title 44: Emergency Management and Assistance
Title 45: Public Welfare
Title 46: Shipping
Title 47: Telecommunication (also known as the "FCC Rules", administered by the Federal Communications Commission)
Title 48: Federal Acquisition Regulations System
Title 49: Transportation
Title 50: Wildlife and Fisheries
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Recent development
• Traceability Reviewed by FDA/FSIS (December 2009)
• Federal food safety agencies need to increase
the speed and accuracy of traceback
investigations and traceforward operations.
• FDA commissioned IFT to examine traceability
system (report published in January 2010)
•
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/Docket_NoFDA-2009-0523.htm
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
FDA/FSIS Reviews
• FDA and FSIS intend the public meeting to stimulate and focus a discussion
about the core elements of product tracing systems, gaps in current
product tracing systems, and mechanisms to enhance product tracing
systems for food. FDA and FSIS also intend the public meeting to improve
the ability of FDA and FSIS to use the information in such systems to
identify the source of contamination during outbreaks of foodborne
illness, and to improve the ability of all persons in the supply chain to
more quickly identify food that is (or potentially is) contaminated and
remove it from the market during traceforward operations. This discussion
will help FDA and FSIS determine what short and long term steps each
agency should take to enhance the current tracing system.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
กฎหมายที่เกี่ยวข้อง
• FDA Several sections in the FFDCA (such as
sections 301, 402, 403, 412, 414, 416, 417 and
704(a)) (21 U.S.C. 321, 342, 343, 350(a),
350(c), 350(e), 350(f), and 374(a)) and section
361 of the Public Health Service Act (42 U.S.C.
264) provide authority for, or are otherwise
relevant to, product tracing systems.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
21 CFR part 1 subpart j Establishment,
Maintenance, Availability of Records
• Requires certain persons who manufacture, process, pack, transport,
distribute, receive, hold, or import food to establish and maintain certain
records identifying the immediate previous source of all food received, as
well as the immediate subsequent recipient of all food released. The
regulations describe the information that must be established and
maintained, how long it must be maintained, and how quickly it must be
available to FDA when FDA has a reasonable belief that an article of food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals. The regulations also
describe persons (e.g., farms and restaurants) who are excluded from
some or all of the requirements.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Code of Federal Regulations, - Title 21, Food
Labeling1
• Title 21 – parts 100 – 1692
• Title 21--parts 170 to 1993
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
Chapter IV: Food4
• Fair Packaging and Labeling Act of 19665
• http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegula
toryInformation/default.htm
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
•
•
•
•
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
(CONTINUED)
Part 100 General 101 Food labeling 102 Common or usual name for nonstandardized foods 104
Nutritional quality guidelines for foods 105 Foods for special dietary use 106 Infant formula quality control
procedures 107 Infant formula 108 Emergency permit control 109 Unavoidable contaminants in food for
human consumption and food-packaging material 110 Current good manufacturing practice in
manufacturing, packing, or holding human food 111 Current good manufacturing practice in
manufacturing, packaging, labeling, or holding operations for dietary supplements 113 Thermally
processed low-acid foods packaged in hermetically sealed containers 114 Acidified foods 115 Shell eggs
119 Dietary supplements that present a significant or unreasonable risk 120 Hazard Analysis and Critical
Control Point (HACCP) systems 123 Fish and fishery products 129 Processing and bottling of bottled
drinking water 130 Food standards: General 131 Milk and cream 133 Cheeses and related cheese products
135 Frozen desserts 136 Bakery products 137 Cereal flours and related products 139 Macaroni and noodle
products 145 Canned fruits 146 Canned fruit juices 150 Fruit butters, jellies, preserves, and related
products 152 Fruit pies 155 Canned vegetables 156 Vegetable juices 158 Frozen vegetables 160 Eggs and
egg products 161 Fish and shellfish 163 Cacao products 164 Tree nut and peanut products 165 Beverages
166 Margarine 168 Sweeteners and table sirups 169 Food dressings and flavorings
http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfrv2_08.html
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/default.htm
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• 21 CFR 101.3 และ 21 CFR 501.3 Identity labeling
of food in packaged form
– Requires the principal display panel of a food in
package form to bear a statement of the identity
of the commodity.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• 21 CFR 101.5 และ 21 CFR 501.5 Food; name
and place of business of manufacturer, packer,
or distributor.
– Requires the label of a food in packaged form to
specify conspicuously the name and place of
business of the manufacturer, packer, or
distributor.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• 21 CFR 106.90 Infant Formula Quality Control
Procedures
– Requires product coding for all infant formulas.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• 21 CFR part 111 Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for
Dietary Supplements
– Requires, among other things, identification of each lot of received components in a
manner that allows tracing the lot to the supplier and the date received; using this
unique identifier when recording the disposition of the lot of received components;
establishing a batch, lot or control number for each finished batch of dietary
supplements; and being able to determine the complete manufacturing history and
control of the packaged and labeled dietary supplement through distribution.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• 21 CFR, 113.60(c) ; 21 CFR, 114.80(b)
Thermally Processed Low-Acid Foods
Packaged In Hermetically Sealed Containers;
Acidified Foods
– A product code must be established and included on the
package of a food that is a thermally processed low-acid
food packaged in a hermetically sealed container (Sec.
113.60(c)) or an acidified food (Sec. 114.80(b)).
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
•
Section 417 of the FFDCA establishes requirements for FDA to establish a Reportable Food
Registry (RFR). A ``reportable food'' is an article of food (other than dietary supplements or
infant formula) for which there is a reasonable probability that the use of, or exposure to,
such article of food will cause serious adverse health consequences or death to humans or
animals. The purpose of the RFR is to provide a ``reliable mechanism to track patterns of
adulteration in food [which] would support efforts by the Food and Drug Administration to
target limited inspection resources to protect the public health'' (Public Law 110-085, section
1005(a)(4)). In accordance with section 417 of the FFDCA, FDA implemented on September 8,
2009, the RFR electronic portal by which instances of reportable food must be submitted to
FDA by responsible parties and may be submitted by public health officials. Information as to
the immediate prior source of the food and/or ingredients and the immediate subsequent
recipient(s) of the food may be required to be submitted through the electronic portal. FDA
has issued a guidance document (Ref. 11) containing questions and answers relating to the
requirements under section 417 of the FFDCA
.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
the Bioterrorism Act
•
•
•
•
•
•
•
•
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)
directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of
Health and Human Services, to take additional steps to protect the public from a threatened or actual
terrorist attack on the U.S. food supply and other food-related emergencies.
To carry out certain provisions of the Bioterrorism Act, FDA has established new regulations requiring that:
Food facilities are registered with FDA, and
FDA be given advance notice on shipments of imported food.
The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack, or hold food
for human or animal consumption in the U.S. to register with the FDA by December 12, 2003.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or
hold food for consumption in the U.S. are required to register the facility with the FDA.
Domestic facilities are required to register whether or not food from the facility enters interstate
commerce.
Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food
from that facility undergoes further processing (including packaging) by another foreign facility before the
food is exported to the United States. However, if the subsequent foreign facility performs only a minimal
activity, such as putting on a label, both facilities are required to register.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
FSIS
• FSIS' statutes have sections that are
relevant to product tracing systems for
meat, poultry, and egg products subject
to FSIS' jurisdiction.
– the Federal Meat Inspection Act
– the Poultry Products Inspection Act
– the Egg Products Inspection Act
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Section 642 of the Federal Meat Inspection Act (21
U.S.C. 601 et seq.),
• Section 460(b) of the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.), and
• Section 1040 of the Egg Products Inspection Act (21
U.S.C. 1031 et seq.)
– require certain classes of firms and corporations to
maintain, retain, and make available full and correct
business records or transactions in food.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• The regulations implementing those statutory
sections, 9 CFR part 320, 9 CFR part 381, and 9
CFR 590.200, specify businesses and what
types of basic records are required, such as
bills of sale, bills of lading, receiving and
shipping papers, receipts and inventories.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• Under the Federal Meat Inspection Act, FSIS
also has the authority, under certain
circumstances, to mandate specified
recordkeeping by retail stores for certain
violations and to withdraw or modify statutory
exemptions for public health reasons (21
U.S.C. 623 and 454, 9 CFR parts 301 and 381).
•
The United States Code (U.S.C.) is a compilation and codification of the general and permanent federal law of the United States. It
contains 50 titles and is published every six years by the Office of the Law Revision Counsel of the House of Representatives.[
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Under FSIS' Hazard Analysis and Critical Control
Points (HACCP) regulations (9 CFR part 417),
• a meat or poultry establishment is required to
keep records related to its HAACP plan,
including all records associated with its
operation (i.e., monitoring, verification, and
corrective action). The records of these
activities are subject to FSIS review and are to
be made available to FSIS personnel (9 CFR
417.5(e) and (f)).
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
Especially relevant are
• (1) all records, results, and supporting
documentation associated with prerequisite
programs;
• (2) the results and records associated with
testing conducted for the establishment's
business customer; and
• (3) results and records associated with an
establishment's quality control program.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
• All of the records generated under the agency's
statutory authority facilitate FSIS surveillance and
investigation activities, and the control and removal
of adulterated, misbranded, or otherwise illegal or
unsafe products from commerce. Failure to keep
such records negatively affects consumers' health
and FSIS food safety and response activities (e.g.,
foodborne illness investigations, product trace back,
product trace forward, and product recall).
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ปัญหาอุปสรรค
• ไม่สำมำรถตำมสอบได้ รวดเร็ว
• กำรจัดเก็บบันทึกยังไม่เป็ นมำตรฐำนเดียวกัน
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
แหล่งตรวจสอบข้อมูล
• Through the Listserv and Web page, FSIS is able to provide
information to a much broader and more diverse audience. In
addition, FSIS offers an electronic mail subscription service
which provides automatic and customized access to selected
food safety news and information. This service is available at
http://www.fsis.usda.gov/
news_and_events/email_subscription/. Options range from
recalls to export information to regulations, directives and
notices. Customers can add or delete subscriptions
themselves, and have the option to password protect their
accounts.
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ความก้าวหน้าการตามสอบของไทย
• มำตรฐำนกำรตำมสอบ มกษ 9028-2551
หลักการตามสอบสินค้ าที่เป็ นเครื่องมือในระบบการตรวจสอบและออกใบรั บรองสินค้ า
เกษตรและอาหาร
• แผนงำน/โครงกำร ในกระทรวงเกษตรและสหกรณ์
• พัฒนำระบบตำมสอบด้ วยระบบอิเล็กทรอนิกส์
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
โครงการด้านการตามสอบสิ นค้าเกษตรและอาหาร
ของกระทรวงเกษตรและสหกรณ์
โครงการด้ านการตามสอบสินค้ าเกษตรและอาหารของกระทรวงเกษตรและสหกรณ์
ระหว่างปี 2549 / 2555
ชื่อโครงการ
โครงการนาร่ องระบบการตรวจสอบย้ อนกลับ
(Traceability)
งบประมาณ(ล้ านบาท)/(ปี )
หน่ วยงาน
2549 2550 2551 2552 2553 2554 2555 ทีร่ ับผิดชอบ
/
โครงการศึกษาพัฒนาเทคนิคการจัดการข้ อมูล
เพื่อการตรวจสอบย้ อนกลับของกล้ วยโดยใช้
เทคโนโลยีท่เี หมาะสม
มกอช.
/
โครงการพัฒนาการเชื่อมโยงระบบตรวจสอบ
ย้ อนกลับ
มกอช.
/
โครงการตามสอบผลผลิตผักมูลนิธิ
โครงการหลวง
มกอช.
/
โครงการนาร่ องการใช้ เทคโนโลยีเพื่อการ
ตรวจสอบแหล่ งผลิตสินค้ าเกษตรและอาหาร
ตามมาตรฐานสากล
มกอช.
/
โครงการตามสอบสินค้ าเกษตรและอาหารที่
เหมาะสมกับผู้ประกอบการขนาดเล็กและ
ขนาดย่อม
/
โครงการจัดทาระบบตรวจสอบย้ อนกลับ
อุตสาหกรรมไก่
มกอช.
/
กรมปศุสตั ว์
โครงการพัฒนาระบบตรวจสอบย้ อนกลับ
อุตสาหกรรมสุกรและโคเนื้อ
โครงการตรวจสอบย้ อนกลับสินค้ ากุ้ง (Trace
Shrimp) ภายใต้ ความร่ วมมือไทย-อียู
มกอช.
/
กรมปศุสตั ว์
/
กรมประมง
โครงการยกระดับมาตรฐานฟาร์มเพาะเลี้ยงปลา
นิลเพื่อการส่งออกตามแผนฟื้ นฟูเศรษฐกิจ
ระยะปานกลาง (พ.ศ.2553-2555)
* ยังไม่ได้ รับการอนุมัติงบประมาณ
/
/
กรมประมง
/
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
พืช 32 ชนิด
1)
2)
3)
4)
5)
6)
ทุเรียน
ลำไย
ลิน้ จี่
ส้ มโอ
มะม่ วง
มังคุด
7)
8)
9)
10)
11)
12)
13)
14)
ผักชีไทย
ผักชีฝรั่ง
ใบกระเพรำ
ใบโหระพำ
ผักแขยง
ใบสะระแหน่
ผักแพร้ ว
ต้ นหอม
ใบบัวบก
16)
ใบชะพลู
17)
ผักโขมแดง
18)
ถั่วฝักยำว
19)
หน่ อไม้ ฝรั่ง
20)
กระเจี๊ยบเขียว
21)
พริกขีห้ นู
22)
ผักคะน้ ำ
23)
ผักปลัง
ข้ฑ์ำอวโพดฝั
กอ่อ2010
น
FoStat สถำบันค้ นคว้ ำและพัฒ32)
นำผลิตภัณ
ำหำร18 March
15)
คืน่ ไช่
23)
ใบกุ่ยไช่
24)
ดอกกุ่ยไช่
25)
ชะอม
26)
ตะไคร้
27)
ผักบุ้ง
28)
ผักแว่ น
29)
ผักกระเฉด 30)
ข้ ำวโพดฝักอ่อน 31)
แผนผังกระบวนการทางาน
DOA Q-GAP
Registration
.
DOA Q-GAP Field
Details
Q-Mark Details
.
Fertilizer
Application
Pesticide
Application
Planting
Collecting
Center Master
Factory Receipt
Farm Process
DOA Manufacturer
Certificate Evaluated
Certificate of
Pesticide Residues
Collecting
Center Receipt
Harvesting
Farmer Master
Q-Mark
Packing
Product Shipment
Processing Plant Process
DOA Manufacturer
Certificate Evaluated Result
DOA Manufacturer
Registration
.
DOA Manufacturer
Certificate Evaluated-Product
DOA Manufacturer
Certificate Evaluated-Country
RASSFF and Monitor
Information
Phytosanitary
Certificate Details
Phytosanitary
Certificate
.
Phytosanitary
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FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
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ข้ อมูลการใช้ ป๋ ุย
ข้ อมูลการเก็บเกี่ยว
ข้ อมูลการรั บวัตถุดบิ เข้ าโรงงาน
ข้ อมูลการบรรจุ
ข้ อมูลการส่ งออกสินค้ า
ข้ อมูลการส่ งออกสินค้ าและรายละเอียดสินค้ า
ข้ อมูลการส่ งออกสินค้ าและรายละเอียดใบรั บรองสารพิษตกค้ าง
ข้ อมูลการส่ งออกสินค้ าและรายละเอียดใบรั บรองปลอดศัตรู พืช
ข้ อมูลการส่ งออกสินค้ าและรายละเอียดใบรั บรองการส่ งออก
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
หน้ ำจอบันทึกข้ อมูลข้ อมูลทะเบียนเกษตรกร
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ข้ อมูลกำรส่ งออกสิ นค้ ำ
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ข้ อมูลทะเบียนผู้รวบรวม
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ข้ อมูลกำรรับวัตุดบิ ทีจ่ ุดรวบรวม
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ข้ อมูลกำรปลูก
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ข้ อมูลกำรใช้ สำรเคมี
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
รู ปแบบข้อมูลของผูป้ ระกอบการที่นาเข้าสู่ ระบบ
ตรวจสอบย้อนกลับ
รู ปแบบข้ อมูลทีจ่ ะนำเข้ ำสู่ ระบบได้ กำหนดไว้ 2 รู ปแบบดังนี้
 รู ปแบบ Text ไฟล์ ตำมรู ปแบบทีท่ ำงระบบของกรมวิชำกำรเกษตรกำหนด
 รู ปแบบ Excel ไฟล์ ตำมรู ปแบบทีท่ ำงระบบของกรมวิชำกำรเกษตรกำหนด
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ประโยชน์ของผูป้ ระกอบการที่เข้าร่ วมโครงการ
 ผู้ประกอบกำรจะได้ รับอนุญำตให้ สำมำรถใช้ ระบบทีจ่ ัดทำขึน้ เพือ่ ตรวจสอบ
ย้อนกลับสิ นค้ ำของตนเองได้
เพือ่ เตรียมควำมพร้ อมของผู้ประกอบกำรทีจ่ ะส่ งออกสิ นค้ ำในอนำคต ซึ่ง
สหภำพยุโรปจะบังคับให้ ผ้ ปู ระกอบกำรต้ องมีระบบตรวจสอบย้ อยกลับสิ นค้ ำได้
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010
ขอบคุณครับ
พรพรหม ชัยฤทธิไชย
ผู้อำนวยกำรศูนย์สำรสนเทศ มกอช
pchairidchai@acfs.go.th
www.acfs.go.th
FoStat สถำบันค้ นคว้ ำและพัฒนำผลิตภัณฑ์อำหำร18 March 2010