What Is The Difference Between The HACCP and HARPC
What Is The Difference Between The HACCP and HARPC
What Is The Difference Between The HACCP and HARPC
Under the FSMA act, the FDA now has a legislative mandate to require
comprehensive, science-based preventive controls across the food supply chain. This
means that all food facilities that fall under the FSMA act must conduct Hazard
Analysis and Risk-Based Preventive Controls (HARPC) and shall establish
.science-based preventive control measures to reduce the risk of food contamination
:The primary focus for all food processors now should be twofold
The HARPC plan has a similar concept and goal, but the approach is different from
cGMP and HACCP, as HARPC enforces preventive controls in order to identify
potential risks or threats to the food supply and to implement appropriate corrective
actions proactively to prevent contamination. The FDA will establish science-based
standards for conducting a hazard analysis, and implementing and documenting
.preventive controls
Facilities under USDA jurisdiction handling, processing, and shipping meat, poultry,
.eggs, etc
.Operations under the FDA’s Seafood and Juice HACCP regulations
Facilities subject to the FDA’s new standards for Produce Safety Authorities. This
exemption applies to farms, cooperatives, growers, harvesters and other companies
.handling raw fresh fruits and vegetables
.Low acid and acidified canned food processors
.Facilities defined as “small” or “very small” businesses
Facilities with a previous 3-year average product value or revenue of less than
.$500,000
Facilities that mainly produce food for animals, store raw agricultural commodities
other than fruits and vegetables intended for further processing, or facilities that store
.packaged food not exposed to the environment for potential cross-contamination
Facilities that are mainly engaged in manufacturing, processing, packing or holding
that are considered to be low risk operations, such as shelling and hulling of almonds
.
.Retail food establishments, restaurants, and farms
?Who needs a HARPC plan
Any facility that manufactures, processes, packs, distributes, receives, holds or
imports food must develop a HARPC plan for compliance with the FSMA HARPC
.compliance
Except as exempted above, all facilities subjected to the FDA’s Bioterrorism Facility
Establishment registration, both in the United States and abroad, that are producing
food products for distribution in the United States must develop and implement a
HARPC plan that identifies risks “known or reasonably foreseeable” for each type of
food subject to the regulation. The preventive controls should be adequate to
“significantly minimize or prevent” identified hazards so that the food is safe. The
facility must provide a HARPC plan to the FDA upon receiving an oral or written
.request
?How frequently does the HARPC need to be updated and submitted to the FDA
The FDA requires that a facility update its HARPC plan every 3 years or whenever
there is a significant change in the processing facility that may increase a potential
hazard or introduce a new hazard. Additionally, the FDA under the FSMA statute may
require an updated plan based on unintentional or new hazards associated with
biological, chemical, radiological or terrorist threats that may occur at a food facility
.that manufactures, processes, packs or holds food intended for human consumption
What consequences can the FDA impose if no HARPC plan is in place or the plan is
?inadequate
If a facility mandated to develop a HARPC plan does not create a plan or if the FDA
inspector determines that a HARPC plan is inadequate to address threats, the FDA
:can
Issue a public warning letter and/or an import alert for a foreign supplier, effectively
banning imports from such a foreign supplier. Food products from a foreign facility or
supplier that is placed on the import alert would be detained at US ports on arrival,
thereby effectively barring it from entering into US commerce until the FDA reviews
.and approves an updated HARPC plan
Criminally charge a corporation or the person in charge of a facility for failing to meet
.HARPC compliance
Suspend the facility’s food facility registration, thus preventing the facility from
distributing food in the US until the FDA approves the updated plan and corrective
actions. This would take place if food from a non-compliant facility is found to pose a
.significant food safety risk
In terms of validating process control, will the FDA be flexible in accepting
?tried-and-true operations or will new studies need to be conducted
The FDA may accept tried–and-true operations. For example, process controls such
as an internal temperature of 165°F or a pH level that is less than 4.6 or a water
activity of less than 0.85 have been scientifically proven to eliminate the risk of certain
pathogens associated with a cook process. Trade association data or published data
can also be used to show that the controls for your process have been supported by
.established scientific data and literature
New studies would be required if your process or product is new or novel and there is
no scientific data or literature available to validate the effectiveness of process
.controls at mitigating hazards
Under the proposed act, the FDA will review and evaluate relevant data, at least every
two years, to determine which foodborne contaminants present the greatest food
safety risk and issue relevant guidance documents, regulations and preventive action
.levels
Under the proposed act, the FDA will review and evaluate relevant data, at least every
two years, to determine which foodborne contaminants present the greatest food
safety risk and issue relevant guidance documents, regulations and preventive action
.levels
References
www.FDA.gov/FSMA
(The David Acheson Group – (various documents for their website
(FSMA Friday (Various Webinars
ﺗﻢ.2011 ( ﻟﯿﺼﺒﺢ ﻗﺎﻧﻮ ًﻧﺎ ﻣﻦ ﻗِﺒﻞ ﻛﻮﻧﻐﺮس اﻟﻮﻻﯾﺎت اﻟﻤﺘﺤﺪة ﻓﻲ ﻋﺎمFSMA) ﺗﻢ اﻟﺘﻮﻗﯿﻊ ﻋﻠﻰ ﻗﺎﻧﻮن ﺗﺤﺪﯾﺚ ﺳﻼﻣﺔ اﻷﻏﺬﯾﺔ
اﻟﻤﻘﺘﺮﺣﺔ ﻫﻮFSMA إن ﺟﻮﻫﺮ ﻗﻮاﻋﺪ. اﻟﺠﺪﯾﺪة ﻟﺴﻼﻣﺔ اﻷﻏﺬﯾﺔFSMA ( ﺑﺘﻨﻔﯿﺬ ﻟﻮاﺋﺢFDA) ﺗﻜﻠﯿﻒ إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ
ﻣﻊ ﻋﻮﻟﻤﺔ ﺳﻠﺴﻠﺔ اﻹﻣﺪاد ﺑﺎﻷﻏﺬﯾﺔ واﻟﻤﺨﺎﻃﺮ اﻟﻨﺎﺷﺌﺔ اﻟﺠﺪﯾﺪة.اﻟﻮﻗﺎﯾﺔ ؛ أي اﻟﺘﺤﻮل ﻣﻦ رد اﻟﻔﻌﻞ إﻟﻰ اﻟﻨﻬﺞ اﻟﻮﻗﺎﺋﻲ واﻟﻮﻗﺎﺋﻲ
أو ﻣﻨﻊ اﺣﺘﻤﺎل ﺗﻠﻮث اﻷﻏﺬﯾﺔ/ ﻟﻢ ﺗﻌﺪ "ﻣﺎذا ﺳﺘﻔﻌﻞ إذا" ﺑﻞ أﺻﺒﺤﺖ "ﻣﺎذا ﺳﺘﻔﻌﻞ ﻋﻨﺪﻣﺎ" ﻟﺘﻘﻠﯿﻞ و، اﻟﻤﺘﻌﻠﻘﺔ ﺑﺴﻼﻣﺔ اﻷﻏﺬﯾﺔ
ً
.وأﯾﻀﺎ ﻗﻠﻞ ﻣﻦ اﺳﺘﺮﺟﺎع اﻷﻏﺬﯾﺔ ﻋﺒﺮ ﺳﻠﺴﻠﺔ إﻣﺪادﻧﺎ اﻟﻐﺬاﺋﯿﺔ ﺑﺸﻜﻞ اﺳﺘﺒﺎﻗﻲ
اﻵن ﺗﻔﻮﯾﺾ ﺗﺸﺮﯾﻌﻲ ﯾﺘﻄﻠﺐ ﺿﻮاﺑﻂ وﻗﺎﺋﯿﺔ ﺷﺎﻣﻠﺔ ﺗﺴﺘﻨﺪ إﻟﻰ اﻟﻌﻠﻢ ﻋﺒﺮ ﺳﻠﺴﻠﺔFDA أﺻﺒﺢ ﻟﺪى، FSMA ﺑﻤﻮﺟﺐ ﻗﺎﻧﻮن
ﯾﺠﺐ أن ﺗﻘﻮم ﺑﺘﺤﻠﯿﻞ اﻟﻤﺨﺎﻃﺮ واﻟﻀﻮاﺑﻂFSMA ﻫﺬا ﯾﻌﻨﻲ أن ﺟﻤﯿﻊ اﻟﻤﻨﺸﺂت اﻟﻐﺬاﺋﯿﺔ اﻟﺘﻲ ﺗﻘﻊ ﺗﺤﺖ ﻗﺎﻧﻮن.اﻹﻣﺪاد اﻟﻐﺬاﺋﻲ
.( وأن ﺗﻀﻊ ﺗﺪاﺑﯿﺮ رﻗﺎﺑﺔ وﻗﺎﺋﯿﺔ ﺗﺴﺘﻨﺪ إﻟﻰ اﻟﻌﻠﻢ ﻟﻠﺤﺪ ﻣﻦ ﻣﺨﺎﻃﺮ ﺗﻠﻮث اﻟﻐﺬاءHARPC) اﻟﻮﻗﺎﺋﯿﺔ اﻟﻤﺴﺘﻨﺪة إﻟﻰ اﻟﻤﺨﺎﻃﺮ
، ﻟﻔﻬﻢ ﻛﯿﻔﯿﺔ ﻣﻘﺎرﻧﺔ ﻗﻮاﻋﺪ اﻟﺮﻗﺎﺑﺔ اﻟﻮﻗﺎﺋﯿﺔ اﻟﻘﺎﺋﻤﺔ ﻋﻠﻰ اﻟﻤﺨﺎﻃﺮ ﻣﻊ ﻣﺒﺎدئ ﺗﺤﻠﯿﻞ اﻟﻤﺨﺎﻃﺮ وﻧﻘﺎط اﻟﻤﺮاﻗﺒﺔ اﻟﺤﺮﺟﺔ
. اﻟﺠﺪﯾﺪ ﻟﻤﻨﻊ ﺧﻄﺮ ﺗﻠﻮث اﻷﻏﺬﯾﺔFSMA ﻟﻮﺿﻊ ﺿﻮاﺑﻂ اﻟﻌﻤﻠﯿﺔ ﻣﻦ أﺟﻞ ﺗﺤﻘﯿﻖ واﻟﻤﺤﺎﻓﻈﺔ ﻋﻠﻰ اﻻﻣﺘﺜﺎل ﻟﻘﺎﻧﻮن
ﺗﻢ ﺗﺼﻤﯿﻢ ﺗﺤﻠﯿﻞ اﻟﻤﺨﺎﻃﺮ وﻧﻘﻄﺔ اﻟﺘﺤﻜﻢ اﻟﺤﺮﺟﺔ ) (HACCPوﻣﻤﺎرﺳﺎت اﻟﺘﺼﻨﯿﻊ اﻟﺠﯿﺪة اﻟﺤﺎﻟﯿﺔ ) (cGMPﺑﺸﻜﻞ أﺳﺎﺳﻲ
ﻟﻀﻤﺎن ﺗﺼﻨﯿﻊ اﻷﻏﺬﯾﺔ وﻣﻌﺎﻟﺠﺘﻬﺎ وﺗﻌﺒﺌﺘﻬﺎ وﺗﺨﺰﯾﻨﻬﺎ ﻓﻲ ﻇﺮوف ﺻﺤﯿﺔ ﻟﻤﻨﻊ ﺗﻠﻮث ﻣﺎ ﺑﻌﺪ اﻟﻌﻤﻠﯿﺔ ﻟﻀﻤﺎن ﺳﻼﻣﺔ اﻷﻏﺬﯾﺔ ،ﺻﺤﯿﺔ
،ودون ﺗﺪﻫﻮر ﺟﻮدة ﻣﺮﺋﯿﺔ.
وﻫﺪﻓﺎ ﻣﺸﺎﺑﻬﯿﻦ ،ﻟﻜﻦ اﻟﻨﻬﺞ ﯾﺨﺘﻠﻒ ﻋﻦ cGMPو ، HACCPﺣﯿﺚ إن HARPCﺗﻔﺮض ً ﻣﻔﻬﻮﻣﺎ
ً ﺗﺘﻀﻤﻦ ﺧﻄﺔ HARPC
ﺿﻮاﺑﻂ وﻗﺎﺋﯿﺔ ﻣﻦ أﺟﻞ ﺗﺤﺪﯾﺪ اﻟﻤﺨﺎﻃﺮ أو اﻟﺘﻬﺪﯾﺪات اﻟﻤﺤﺘﻤﻠﺔ ﻹﻣﺪادات اﻷﻏﺬﯾﺔ وﺗﻨﻔﯿﺬ اﻹﺟﺮاءات اﻟﺘﺼﺤﯿﺤﯿﺔ اﻟﻤﻨﺎﺳﺒﺔ ﺑﺸﻜﻞ
اﺳﺘﺒﺎﻗﻲ ﻟﻤﻨﻊ اﻟﺘﻠﻮث .ﺳﺘﻀﻊ إدارة اﻟﻐﺬاء واﻟﺪواء اﻷﻣﺮﯾﻜﯿﺔ ﻣﻌﺎﯾﯿﺮ ﺗﺴﺘﻨﺪ إﻟﻰ اﻟﻌﻠﻢ ﻹﺟﺮاء ﺗﺤﻠﯿﻞ ﻟﻠﻤﺨﺎﻃﺮ وﺗﻨﻔﯿﺬ وﺗﻮﺛﯿﻖ
اﻟﻀﻮاﺑﻂ اﻟﻮﻗﺎﺋﯿﺔ.
ﻣﻄﻠﻮب "ﻓﺮد ﻣﺆﻫﻞ" أو "ﻓﺮﯾﻖ ﻣﻦ اﻷﻓﺮاد اﻟﻤﺆﻫﻠﯿﻦ" ﻣﻦ اﻟﻤﻨﺸﺄة ﻟﻔﻬﻢ ﻣﺨﺎﻃﺮ اﻟﺴﻼﻣﺔ اﻟﻐﺬاﺋﯿﺔ اﻟﻬﺎﻣﺔ ووﺿﻊ ﺿﻮاﺑﻂ وﻗﺎﺋﯿﺔ
ﻟﺘﻘﻠﯿﻞ ﻣﺨﺎﻃﺮ اﻷﺧﻄﺎر .ﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ ﺗﻮاﻓﻖ HARPCاﻟﻤﻘﺘﺮح ﺟﯿﺪًا ﻣﻊ ﺧﻄﺔ ﺗﺤﻠﯿﻞ اﻟﻤﺨﺎﻃﺮ وﻧﻘﻄﺔ اﻟﺘﺤﻜﻢ اﻟﺤﺮﺟﺔ )
، (HACCPإﻻ أﻧﻪ ﯾﺨﺘﻠﻒ ﺟﺰﺋﯿًﺎ ﻋﻦ اﻟﺤﺎﺟﺔ إﻟﻰ اﻟﻀﻮاﺑﻂ اﻟﻮﻗﺎﺋﯿﺔ اﻟﻘﺎﺋﻤﺔ ﻋﻠﻰ اﻟﻌﻠﻢ ،ﺑﺪ ًﻻ ﻣﻦ ﻧﻘﺎط اﻟﺘﺤﻜﻢ اﻟﺤﺮﺟﺔ .ﻟﺬﻟﻚ ،ﻟﻦ
ﺗﻜﻮن ﻫﻨﺎك ﺣﺎﺟﺔ إﻟﻰ وﺿﻊ ﺣﺪود ﺣﺮﺟﺔ ﺑﻤﻮﺟﺐ .HARPCوﻣﻊ ذﻟﻚ ،ﯾﻨﺒﻐﻲ دﻋﻢ ﺻﺤﺔ اﻟﻀﻮاﺑﻂ اﻟﻮﻗﺎﺋﯿﺔ ﻟﻠﺘﻘﻠﯿﻞ إﻟﻰ أدﻧﻰ ﺣﺪ
ﻣﻦ اﻟﻤﺨﺎﻃﺮ اﻟﻐﺬاﺋﯿﺔ اﻟﻬﺎﻣﺔ ﺑﺎﻟﺒﯿﺎﻧﺎت اﻟﻌﻠﻤﯿﺔ اﻟﻤﺜﺒﺘﺔ أو "اﻟﻤﺠﺮﺑﺔ واﻟﺤﻘﯿﻘﯿﺔ" أو اﻟﻤﺆﻟﻔﺎت اﻟﻌﻠﻤﯿﺔ اﻷﺻﻠﯿﺔ .ﺧﻄﺔ HACCP
ﻟﯿﺴﺖ إﻟﺰاﻣﯿﺔ وﻟﻜﻦ FSMA HARPCﻣﻜﻠﻒ ﺑﻤﻮﺟﺐ اﻟﻘﺎﻧﻮن ﺑﻤﻮﺟﺐ ﻗﺎﻧﻮن .FSMA
اﻟﻤﻨﺸﺂت اﻟﺨﺎﺿﻌﺔ ﻟﻠﻮﻻﯾﺔ اﻟﻘﻀﺎﺋﯿﺔ ﻟﻮزارة اﻟﺰراﻋﺔ اﻷﻣﺮﯾﻜﯿﺔ ،ﻣﻌﺎﻟﺠﺔ ،ﺷﺤﻦ ،اﻟﻠﺤﻮم ،اﻟﺪواﺟﻦ ،اﻟﺒﯿﺾ ،إﻟﺦ.
اﻟﻌﻤﻠﯿﺎت ﺑﻤﻮﺟﺐ ﻟﻮاﺋﺢ HACCPﻟﻠﻤﺄﻛﻮﻻت اﻟﺒﺤﺮﯾﺔ واﻟﻌﺼﺎﺋﺮ.
اﻟﻤﻨﺸﺂت اﻟﺨﺎﺿﻌﺔ ﻟﻤﻌﺎﯾﯿﺮ إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ اﻟﺠﺪﯾﺪة ﻟﺴﻠﻄﺎت ﺳﻼﻣﺔ اﻟﻤﻨﺘﺠﺎت .ﯾﻨﻄﺒﻖ ﻫﺬا اﻹﻋﻔﺎء ﻋﻠﻰ اﻟﻤﺰارع واﻟﺘﻌﺎوﻧﯿﺎت
واﻟﻤﺰارﻋﯿﻦ واﻟﺤﺼﺎدات واﻟﺸﺮﻛﺎت اﻷﺧﺮى اﻟﺘﻲ ﺗﺘﻌﺎﻣﻞ ﻣﻊ اﻟﻔﻮاﻛﻪ واﻟﺨﻀﺮوات اﻟﻄﺎزﺟﺔ اﻟﻨﯿﺌﺔ.
ﺣﺎﻣﺾ ﻣﻨﺨﻔﺾ وﺣﺎﻣﺾ ﻟﻸﻃﻌﻤﺔ اﻟﻤﻌﻠﺒﺔ.
اﻟﻤﻨﺸﺂت اﻟﻤﻌ ّﺮﻓﺔ ﺑﺄﻧﻬﺎ أﻋﻤﺎل "ﺻﻐﯿﺮة" أو "ﺻﻐﯿﺮة ﺟﺪًا".
ﺗﺴﻬﯿﻼت ﻣﻊ ﻣﺘﻮﺳﻂ ﻗﯿﻤﺔ اﻟﻤﻨﺘﺞ اﻟﺴﺎﺑﻖ أو إﯾﺮادات أﻗﻞ ﻣﻦ 3ﺳﻨﻮات أﻗﻞ ﻣﻦ 500،000دوﻻر.
اﻟﻤﻨﺸﺂت اﻟﺘﻲ ﺗﻨﺘﺞ اﻟﻐﺬاء ﻟﻠﺤﯿﻮاﻧﺎت ﺑﺸﻜﻞ أﺳﺎﺳﻲ ،ﺗﺨﺰن اﻟﺴﻠﻊ اﻟﺰراﻋﯿﺔ اﻟﺨﺎم ﺑﺨﻼف اﻟﻔﻮاﻛﻪ واﻟﺨﻀﺮوات اﻟﻤﻌﺪة ﻟﻤﺰﯾﺪ ﻣﻦ
اﻟﻤﻌﺎﻟﺠﺔ ،أو اﻟﻤﻨﺸﺂت اﻟﺘﻲ ﺗﺨﺰن اﻷﻏﺬﯾﺔ اﻟﻤﻌﺒﺄة اﻟﺘﻲ ﻻ ﺗﺘﻌﺮض ﻟﻠﺒﯿﺌﺔ ﻣﻦ أﺟﻞ اﻟﺘﻠﻮث اﻟﻤﺤﺘﻤﻞ اﻟﻤﺤﺘﻤﻞ.
اﻟﻤﻨﺸﺂت اﻟﺘﻲ ﺗﻌﻤﻞ ﺑﺸﻜﻞ رﺋﯿﺴﻲ ﻓﻲ اﻟﺘﺼﻨﯿﻊ أو اﻟﺘﺠﻬﯿﺰ أو اﻟﺘﻌﺒﺌﺔ أو اﻟﺤﺠﺰ واﻟﺘﻲ ﺗﻌﺘﺒﺮ ﻋﻤﻠﯿﺎت ﻣﻨﺨﻔﻀﺔ اﻟﻤﺨﺎﻃﺮ ،ﻣﺜﻞ
اﻟﻘﺼﻒ وﺗﻘﺸﯿﺮ اﻟﻠﻮز.
ﻣﺆﺳﺴﺎت اﻟﺒﯿﻊ ﺑﺎﻟﺘﺠﺰﺋﺔ واﻟﻤﻄﺎﻋﻢ واﻟﻤﺰارع.
ﻣﻦ ﯾﺤﺘﺎج ﻟﺨﻄﺔ HARPC؟
ﯾﺠﺐ أن ﺗﻀﻊ أي ﻣﻨﺸﺄة ﺗﻘﻮم ﺑﺘﺼﻨﯿﻊ أو ﻣﻌﺎﻟﺠﺔ أو ﺣﺰم أو ﺗﻮزﯾﻊ أو اﺳﺘﻼم أو ﺣﺠﺰ أو اﺳﺘﯿﺮاد ﻃﻌﺎم ﺧﻄﺔ HARPCﻟﻼﻣﺘﺜﺎل
ﻻﻣﺘﺜﺎل .FSMA HARPC
ﺑﺎﺳﺘﺜﻨﺎء ﻣﺎ ﺗﻢ إﻋﻔﺎؤه أﻋﻼه ،ﯾﺠﺐ ﻋﻠﻰ ﺟﻤﯿﻊ اﻟﻤﻨﺸﺂت اﻟﺨﺎﺿﻌﺔ ﻟﺘﺴﺠﯿﻞ ﻣﺆﺳﺴﺔ ﻣﺮﻓﻖ اﻹرﻫﺎب اﻟﺒﯿﻮﻟﻮﺟﻲ اﻟﺘﺎﺑﻊ ﻹدارة اﻷﻏﺬﯾﺔ
واﻟﻌﻘﺎﻗﯿﺮ ،ﺳﻮاء ﻓﻲ اﻟﻮﻻﯾﺎت اﻟﻤﺘﺤﺪة أو ﺧﺎرﺟﻬﺎ ،واﻟﺘﻲ ﺗﻨﺘﺞ ﻣﻨﺘﺠﺎت ﻏﺬاﺋﯿﺔ ﻟﻠﺘﻮزﯾﻊ ﻓﻲ اﻟﻮﻻﯾﺎت اﻟﻤﺘﺤﺪة ،وﺿﻊ وﺗﻨﻔﯿﺬ ﺧﻄﺔ
HARPCﺗﺤﺪد اﻟﻤﺨﺎﻃﺮ "اﻟﻤﻌﺮوﻓﺔ أو اﻟﻤﺘﻮﻗﻌﺔ ﺑﺸﻜﻞ ﻣﻌﻘﻮل "ﻟﻜﻞ ﻧﻮع ﻣﻦ اﻟﻤﻮاد اﻟﻐﺬاﺋﯿﺔ اﻟﺨﺎﺿﻌﺔ ﻟﻠﺘﻨﻈﯿﻢ .ﯾﺠﺐ أن ﺗﻜﻮن
اﻟﻀﻮاﺑﻂ اﻟﻮﻗﺎﺋﯿﺔ ﻛﺎﻓﯿﺔ "ﻟﺘﻘﻠﯿﻞ أو ﻣﻨﻊ" اﻟﻤﺨﺎﻃﺮ اﻟﻤﺤﺪدة ﺑﺸﻜﻞ ﻛﺒﯿﺮ ﺣﺘﻰ ﯾﻜﻮن اﻟﻐﺬاء آﻣﻨًﺎ .ﯾﺠﺐ أن ﯾﻘﺪم اﻟﻤﺮﻓﻖ ﺧﻄﺔ
HARPCإﻟﻰ إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﻓﻮر ﺗﻠﻘﻲ ﻃﻠﺐ ﺷﻔﻬﻲ أو ﻛﺘﺎﺑﻲ.
ﻛﻢ ﻣﺮة ﺗﺤﺘﺎج HARPCإﻟﻰ اﻟﺘﺤﺪﯾﺚ وﺗﻘﺪﯾﻤﻬﺎ إﻟﻰ إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ؟
ﺗﺘﻄﻠﺐ إدارة اﻟﻐﺬاء واﻟﺪواء ) (FDAأن ﺗﻘﻮم اﻟﻤﻨﺸﺄة ﺑﺘﺤﺪﯾﺚ ﺧﻄﺘﻬﺎ HARPCﻛﻞ 3ﺳﻨﻮات أو ﻋﻨﺪﻣﺎ ﯾﻜﻮن ﻫﻨﺎك ﺗﻐﯿﯿﺮ ﻛﺒﯿﺮ
ﻓﻲ ﻣﻨﺸﺄة اﻟﻤﻌﺎﻟﺠﺔ اﻟﺘﻲ ﻗﺪ ﺗﺰﯾﺪ ﻣﻦ ﺧﻄﺮ ﻣﺤﺘﻤﻞ أو ﺗﺸﻜﻞ ﺧﻄﺮا ﺟﺪﯾﺪا .ﺑﺎﻹﺿﺎﻓﺔ إﻟﻰ ذﻟﻚ ،ﻗﺪ ﺗﻄﻠﺐ إدارة اﻟﻐﺬاء واﻟﺪواء
اﻷﻣﺮﯾﻜﯿﺔ ) (FDAﺑﻤﻮﺟﺐ ﻗﺎﻧﻮن FSMAﺧﻄﺔ ﻣﺤﺪّﺛﺔ ﺗﺴﺘﻨﺪ إﻟﻰ أﺧﻄﺎر ﻏﯿﺮ ﻣﻘﺼﻮدة أو ﺟﺪﯾﺪة ﻣﺮﺗﺒﻄﺔ ﺑﺎﻟﺘﻬﺪﯾﺪات اﻟﺒﯿﻮﻟﻮﺟﯿﺔ
أو اﻟﻜﯿﻤﯿﺎﺋﯿﺔ أو اﻹﺷﻌﺎﻋﯿﺔ أو اﻹرﻫﺎﺑﯿﺔ اﻟﺘﻲ ﻗﺪ ﺗﺤﺪث ﻓﻲ ﻣﻨﺸﺄة أﻏﺬﯾﺔ ﺗﻘﻮم ﺑﺘﺼﻨﯿﻊ أو ﺗﺠﻬﯿﺰ أو ﺣﺰم أو ﺣﻔﻆ اﻷﻏﺬﯾﺔ اﻟﻤﺨﺼﺼﺔ
ﻟﻼﺳﺘﻬﻼك اﻟﺒﺸﺮي.
ﻣﺎ ﻫﻲ اﻟﻌﻮاﻗﺐ اﻟﺘﻲ ﯾﻤﻜﻦ أن ﺗﻔﺮﺿﻬﺎ ادارة اﻻﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﻓﻲ ﺣﺎﻟﺔ ﻋﺪم وﺟﻮد ﺧﻄﺔ HARPCأو ﻋﺪم ﻛﻔﺎﯾﺔ اﻟﺨﻄﺔ؟
إذا ﻛﺎﻧﺖ اﻟﻤﻨﺸﺄة اﻟﻤﻜﻠﻔﺔ ﺑﺘﻄﻮﯾﺮ ﺧﻄﺔ HARPCﻻ ﺗﻨﺸﺊ ﺧﻄﺔ أو إذا ﻗﺮر ﻣﻔﺘﺶ FDAأن ﺧﻄﺔ HARPCﻏﯿﺮ ﻛﺎﻓﯿﺔ
ﻟﻤﻮاﺟﻬﺔ اﻟﺘﻬﺪﯾﺪات ،ﯾﻤﻜﻦ ﻟـ :FDA
إﺻﺪار ﺧﻄﺎب ﺗﺤﺬﯾﺮ ﻋﺎم و /أو ﺗﻨﺒﯿﻪ اﺳﺘﯿﺮاد ﻟﻤﻮرد أﺟﻨﺒﻲ ،ﯾﺤﻈﺮ ﺑﺸﻜﻞ ﻓﻌﺎل اﻟﻮاردات ﻣﻦ ﻣﺜﻞ ﻫﺬا اﻟﻤﻮرد اﻷﺟﻨﺒﻲ .ﺳﯿﺘﻢ
اﺣﺘﺠﺎز اﻟﻤﻨﺘﺠﺎت اﻟﻐﺬاﺋﯿﺔ ﻣﻦ ﻣﻨﺸﺄة أو ﻣﻮرد أﺟﻨﺒﻲ ﯾﺘﻢ وﺿﻌﻪ ﻓﻲ ﺣﺎﻟﺔ ﺗﺄﻫﺐ ﻟﻼﺳﺘﯿﺮاد ﻓﻲ اﻟﻤﻮاﻧﺊ اﻷﻣﺮﯾﻜﯿﺔ ﻟﺪى وﺻﻮﻟﻪ ،
وﺑﺎﻟﺘﺎﻟﻲ ﺗﻤﻨﻌﻪ ﻓﻌﻠﯿًﺎ ﻣﻦ اﻟﺪﺧﻮل ﻓﻲ اﻟﺘﺠﺎرة اﻷﻣﺮﯾﻜﯿﺔ ﺣﺘﻰ ﺗﻘﻮم إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﺑﻤﺮاﺟﻌﺔ واﻋﺘﻤﺎد ﺧﻄﺔ HARPC
اﻟﻤﺤﺪﺛﺔ.
ﻓﺮض رﺳﻮم ﺟﻨﺎﺋﯿﺔ ﻋﻠﻰ اﻟﺸﺮﻛﺔ أو اﻟﺸﺨﺺ اﻟﻤﺴﺆول ﻋﻦ ﻣﻨﺸﺄة ﻟﻔﺸﻠﻬﺎ ﻓﻲ اﻻﻣﺘﺜﺎل ﻻﻣﺘﺜﺎل .HARPC
ﻗﻢ ﺑﺘﻌﻠﯿﻖ ﺗﺴﺠﯿﻞ ﻣﻨﺸﺄة اﻟﻄﻌﺎم ،وﺑﺎﻟﺘﺎﻟﻲ ﻣﻨﻊ اﻟﻤﻨﺸﺄة ﻣﻦ ﺗﻮزﯾﻊ اﻷﻏﺬﯾﺔ ﻓﻲ اﻟﻮﻻﯾﺎت اﻟﻤﺘﺤﺪة ﺣﺘﻰ ﺗﻮاﻓﻖ إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ
ﻋﻠﻰ اﻟﺨﻄﺔ اﻟﻤﺤﺪﺛﺔ واﻹﺟﺮاءات اﻟﺘﺼﺤﯿﺤﯿﺔ .ﻗﺪ ﯾﺤﺪث ﻫﺬا إذا ﺗﻢ اﻟﻌﺜﻮر ﻋﻠﻰ اﻟﻄﻌﺎم ﻣﻦ ﻣﻨﺸﺄة ﻏﯿﺮ ﻣﺘﻮاﻓﻘﺔ ﻟﺨﻄﺮ ﻛﺒﯿﺮ ﻋﻠﻰ
ﺳﻼﻣﺔ اﻷﻏﺬﯾﺔ.
ﻓﯿﻤﺎ ﯾﺘﻌﻠﻖ ﺑﺎﻟﺘﺤﻘﻖ ﻣﻦ ﺻﺤﺔ اﻟﺘﺤﻜﻢ ﻓﻲ اﻟﻌﻤﻠﯿﺔ ،ﻫﻞ ﺳﺘﻜﻮن إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﻣﺮﻧﺔ ﻓﻲ ﻗﺒﻮل اﻟﻌﻤﻠﯿﺎت اﻟﺘﻲ ﺗﻤﺖ ﺗﺠﺮﺑﺘﻬﺎ
وﺻﺪﻗﻬﺎ أم ﺳﺘﺤﺘﺎج إﻟﻰ إﺟﺮاء دراﺳﺎت ﺟﺪﯾﺪة؟
ﻗﺪ ﺗﻘﺒﻞ ادارة اﻻﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﻋﻤﻠﯿﺎت ﻣﺠﺮﺑﺔ وﺣﻘﯿﻘﯿﺔ .ﻋﻠﻰ ﺳﺒﯿﻞ اﻟﻤﺜﺎل ،ﻋﻨﺎﺻﺮ اﻟﺘﺤﻜﻢ ﻓﻲ اﻟﻌﻤﻠﯿﺔ ﻣﺜﻞ درﺟﺔ ﺣﺮارة داﺧﻠﯿﺔ
ﺗﺒﻠﻎ 165درﺟﺔ ﻓﻬﺮﻧﻬﺎﯾﺖ أو ﻣﺴﺘﻮى درﺟﺔ اﻟﺤﻤﻮﺿﺔ أﻗﻞ ﻣﻦ 4.6أو ﻧﺸﺎط ﻣﺎء أﻗﻞ ﻣﻦ 0.85ﻗﺪ ﺛﺒﺖ ﻋﻠﻤﯿًﺎ أﻧﻪ ﯾﺰﯾﻞ ﺧﻄﺮ
أﯾﻀﺎ اﺳﺘﺨﺪام ﺑﯿﺎﻧﺎت اﻻرﺗﺒﺎط اﻟﺘﺠﺎري أو اﻟﺒﯿﺎﻧﺎت اﻟﻤﻨﺸﻮرة ﻹﻇﻬﺎر أن ﺑﻌﺾ ﻣﺴﺒﺒﺎت اﻷﻣﺮاض اﻟﻤﺮﺗﺒﻄﺔ ﺑﻌﻤﻠﯿﺔ اﻟﻄﻬﻲ .ﯾﻤﻜﻦ ً
ﻋﻨﺎﺻﺮ اﻟﺘﺤﻜﻢ ﻓﻲ اﻟﻌﻤﻠﯿﺔ اﻟﺨﺎﺻﺔ ﺑﻚ ﻗﺪ ﺗﻢ دﻋﻤﻬﺎ ﻣﻦ ﺧﻼل اﻟﺒﯿﺎﻧﺎت اﻟﻌﻠﻤﯿﺔ واﻷدﺑﯿﺎت.
ﺳﺘﻜﻮن ﻫﻨﺎك ﺣﺎﺟﺔ ﻟﺪراﺳﺎت ﺟﺪﯾﺪة إذا ﻛﺎﻧﺖ اﻟﻌﻤﻠﯿﺔ أو اﻟﻤﻨﺘﺞ اﻟﺨﺎص ﺑﻚ ﺟﺪﯾﺪًا أو ﺟﺪﯾﺪًا وﻻ ﺗﺘﻮﻓﺮ ﺑﯿﺎﻧﺎت أو ﻣﺆﻟﻔﺎت ﻋﻠﻤﯿﺔ
ﻟﻠﺘﺤﻘﻖ ﻣﻦ ﻓﻌﺎﻟﯿﺔ ﻋﻨﺎﺻﺮ اﻟﺘﺤﻜﻢ ﻓﻲ اﻟﻌﻤﻠﯿﺔ ﻓﻲ ﺗﺨﻔﯿﻒ اﻟﻤﺨﺎﻃﺮ.
ﺑﻤﻮﺟﺐ اﻟﻘﺎﻧﻮن اﻟﻤﻘﺘﺮح ،ﺳﺘﻘﻮم إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﺑﻤﺮاﺟﻌﺔ وﺗﻘﯿﯿﻢ اﻟﺒﯿﺎﻧﺎت ذات اﻟﺼﻠﺔ ،ﻛﻞ ﻋﺎﻣﯿﻦ ﻋﻠﻰ اﻷﻗﻞ ،ﻟﺘﺤﺪﯾﺪ
اﻟﻤﻠﻮﺛﺎت اﻟﺘﻲ ﺗﻨﻘﻠﻬﺎ اﻷﻏﺬﯾﺔ واﻟﺘﻲ ﺗﻤﺜﻞ أﻛﺒﺮ ﺧﻄﺮ ﻋﻠﻰ ﺳﻼﻣﺔ اﻷﻏﺬﯾﺔ وإﺻﺪار وﺛﺎﺋﻖ وﻟﻮاﺋﺢ اﻟﺘﻮﺟﯿﻪ وﻣﺴﺘﻮﯾﺎت اﻹﺟﺮاءات
اﻟﻮﻗﺎﺋﯿﺔ ذات اﻟﺼﻠﺔ.
ﺑﻤﻮﺟﺐ اﻟﻘﺎﻧﻮن اﻟﻤﻘﺘﺮح ،ﺳﺘﻘﻮم إدارة اﻷﻏﺬﯾﺔ واﻟﻌﻘﺎﻗﯿﺮ ﺑﻤﺮاﺟﻌﺔ وﺗﻘﯿﯿﻢ اﻟﺒﯿﺎﻧﺎت ذات اﻟﺼﻠﺔ ،ﻛﻞ ﻋﺎﻣﯿﻦ ﻋﻠﻰ اﻷﻗﻞ ،ﻟﺘﺤﺪﯾﺪ
اﻟﻤﻠﻮﺛﺎت اﻟﺘﻲ ﺗﻨﻘﻠﻬﺎ اﻷﻏﺬﯾﺔ واﻟﺘﻲ ﺗﻤﺜﻞ أﻛﺒﺮ ﺧﻄﺮ ﻋﻠﻰ ﺳﻼﻣﺔ اﻷﻏﺬﯾﺔ وإﺻﺪار وﺛﺎﺋﻖ وﻟﻮاﺋﺢ اﻟﺘﻮﺟﯿﻪ وﻣﺴﺘﻮﯾﺎت اﻹﺟﺮاءات
اﻟﻮﻗﺎﺋﯿﺔ ذات اﻟﺼﻠﺔ.
اﻟﻤﺮاﺟﻊ
www.FDA.gov/FSMA
ﻣﺠﻤﻮﻋﺔ ) - David Achesonوﺛﺎﺋﻖ ﻣﺨﺘﻠﻔﺔ ﻟﻤﻮﻗﻌﻬﺎ ﻋﻠﻰ اﻟﻮﯾﺐ(
) FSMA Fridayﻧﺪوات إﻟﻜﺘﺮوﻧﯿﺔ ﻣﺘﻨﻮﻋﺔ(
ﺗﻢ ﺗﻠﺨﯿﺺ اﻟﻤﻮاد اﻟﻤﻘﺪﻣﺔ ﻓﻲ ﻫﺬه اﻟﻤﻘﺎﻟﺔ ﻣﻦ ﻣﺨﺘﻠﻒ اﻟﻤﻮارد اﻟﻤﺘﺎﺣﺔ ﻋﻠﻰ اﻟﻤﺠﺎل اﻟﻌﺎم واﻟﻤﺮاﺟﻊ اﻟﻤﺬﻛﻮرة ﻫﻨﺎ ،وﺑﺎﻟﺘﺎﻟﻲ ،ﻓﻬﺬه
ﻟﯿﺴﺖ وﺟﻬﺎت ﻧﻈﺮ أو ﺗﻮﺻﯿﺎت ﻫﺬه اﻟﺮﺳﺎﻟﺔ اﻹﺧﺒﺎرﯾﺔ ؛ وﻫﻮ ﻣﺨﺼﺺ ﻓﻘﻂ ﻷﻏﺮاض اﻟﻤﻌﻠﻮﻣﺎت ﻓﻘﻂ .ﻻ ﯾﻘﺼﺪ ﺑﻪ ﺗﻘﺪﯾﻢ اﻟﻤﺸﻮرة
اﻟﻤﻬﻨﯿﺔ وﻻ ﯾﺠﺐ ﺗﻔﺴﯿﺮه ﻋﻠﻰ ﻫﺬا اﻟﻨﺤﻮ.
.