implementation status fsma final rule produce safety
Post on 01-Mar-2018
216 Views
Preview:
TRANSCRIPT
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
1/55
Food Safety
Modernization Act
San Jose, Costa Rica
May 11, 2016
Allan Gonzlez, M.Sc.Analista Regulatorio InternacionalOficina Regional para LatinoamricaAdministracin de Alimentos y Medicamentos (FDA)Embajada EEUU, San Jos, Costa Rica
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
2/55
FDA and Latin America Regional Office
Overview and status of implementation of FSMA
Final Rule: Produce Safety
Agenda
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
3/55
What is FDA? Public Health with regulatory aspect, with
jurisdiction over the following products which are consumed in U.S.
Human Drugs
Prescription, over the counter(OTC), generic
Vaccines, blood products
and other biological products
Blood Supply
Medical Devices
From simple items such astongue depressors, to complextechnologies such aspacemakers
Products that emit radiationMicrowave ovens, tanningbeds, laser pointers
Food
Food safety, food additives(including radiation used totreat food), infant formulas,dietary supplements, foodutensils, containers
Cosmetics
Veterinary Products
Livestock feed, pet food,animal drugs
Tobacco Products
Color additives (for food,drugs, cosmetics)
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
4/55
Important aspects of Food Safety
System in the US.
Shared responsibility between FDA, USDA andEPA
FDA regulates food "interstate commerce"
Transparency of regulations and standards
The same rules for domestic and internationalproduction
All regulations have scientific / risk / and preventive
basis Consistency and predictability of performance
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
5/55
5
FDA is responsible for the safety of 80% of all food consumed inthe US. It Includes supply of domestic and imported foods
Exceptions
Meat and meat products
Poultry and poultry products
Frozen and processed eggs,
dried, liquid
Animal and plant health
FDA vs. USDA Jurisdict ion:
http://www.f
da.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdf
USDA
Regulated
Important aspects of the US Food
Safety System
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdfhttp://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdfhttp://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdf -
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
6/55
Human food groups under FDA
jurisdiction
Dairy products
Milk Cheese
Butter and other dairyproducts (ice cream, yogurt,cream)
Vegetables and derivatives Vegetables
Fruits
Nuts
Juices
Spices and seasonings, foodadditives
Infant formula
Fish and Seafood Fish
Seafood
Crustaceans
Surimi based on themGrains y derivatives
Bread
Cereals
Flours /Confectionary
Dietary Supplements
Bottled water and drinks
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
7/55
77
FDA International Offices
Beijing
Santiago
Mexico City
San Jose
New Delhi
Mumbai
London
Brussels
Headquarters
Silver Spring, MD
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
8/55
Regional Offices Functions
To establish links with competent authorities tobetter understanding of the regulatory systemsand information exchange
To collaborate and coordinate with competentrelevant authorities and institutions in areas ofoutreach and training to help ensure safety and/ or effectiveness of FDA-regulated products.
To help to obtain a better chance of compliancefor products that are exported to the US.
8
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
9/55
Functions of Regional Offices
To work with the regulated industry in compliance
To increase the ability to make more timely andproductive inspections
To coordinate and collaborate with sister agencies
of US Gob. (FAS, APHIS, FSIS, EPA, Commerce)with representatives in the region, in areas ofmutual interest: dissemination, training, technicalassistance.
To provide technica assistance
9
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
10/55
FDA - Latina America Regional
Office
OIP-LAO-MexicoPhilip Budashewitz
Patricia Oliva Romero (Admin.)
Medical Devices and Cosmetics:
Rafael Nevarez
Ana Patricia Pineda
Human and Animal Food
Ana Lilia Sandoval
Office coverage: Mexico
Phone number: +52 55 5028-5440
OIP-LAO-ChileJulio Salazar
Soledad Muoz (Admin.)
Gonzalo Ibanez
Office coverage:
South America
Phone number: +52 2 2330-3035
OIP-LAO-Costa RicaEdmundo Garcia
Marcia Miller (Admin.)
Kenneth Nieves
Allan Gonzlez
Office coverage:
Central Americ and Caribbean
Phone number: +506-2519-2224
FDA- Latin America Regional Office
Edmundo Garcia, DirectorPhilip Budashewitz, Deputy DirectorInboxo for assistance: US-FDA-LAO@fda.hhs.gov
Telephone number: +(506) 2519-2224
mailto:US-FDA-LAO@fda.hhs.govmailto:US-FDA-LAO@fda.hhs.gov -
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
11/5511
Latin America Regional Office:
Coverage and Profile
FDA-LAO provides attention to 44 countries
and territories, includding Mexico, Central
America, South Americ and the Caribbean
~ 30% all products regulated by FDA comefrom Latin America and the Caribbean.
The imported products from the region are: 48% Food 47% Medical devices 5% Drugs, biological products,
tobacco, feed (*FY14 data) Clinical research sites: Argentina, Brazil
and Mexico are the largest in the region
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
12/55
FSMA
Food Safety Modernization Act
12
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
13/55
Why a new law is needed?
Foodborne illnesses are a significant burden
In U.S.:
Aproximately 48 million (1 in 6 Americans) get sick ayear
128,000 are hospitalized
3,000 die
http://www.cdc.gov/foodborneburden/index.html
13
http://www.cdc.gov/foodborneburden/index.htmlhttp://www.cdc.gov/foodborneburden/index.htmlhttp://www.cdc.gov/foodborneburden/index.html -
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
14/55
Food Safety Modernization Act
Food Drug andCosmetics Act (1938).Amendment (1973).
President Obama signedFood SafetyModernization Act onJanuary 4, 2011.
14
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
15/55
Rules
1. Preventive Controls for Human Food
2. Preventive Controls for Animal Food
3. Produce Safety
4. Foreign Supplier Verification Programs
5. Accredited Third-Party Certification
6. Sanitary Transportation of Human and Animal Food
7. Focused Mitigation Strategies to Protect Food Against
Intentional Adulteration
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
16/55
FSMA Main Topics
Prevention
Inspections,Compliance,and Response/Application
Import Safety
EnhancePartnerships
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
17/55
New resources for FDA under FSMA
Authority to order product recalls.
Suspension of registration (inscription)
Biannual Renewal of Registrations
Fees for re-inspections and recalls
17
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
18/55
Import Safety: the most revolutionary
change of FSMA
It is required that foreign foods exported to the EEU are as safe and reliableas those produced domestically.
US importers will now be responsible for ensuring that their foreignsuppliers have adequate preventive controls implemented
FDA can rely on third parties to certify that food companies meet USrequirements
Mandatory certification may be required for high-risk foods
Voluntary Qualified Importer Program (VQIP) - expedited review
Product entry may be denied if FDA access to a company to carry out aninspection is refused.
18
Ph I S i S d d
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
19/55
Regulation Proposal Final
Preventive Controls for HumanFood*
Jan. 16, 2013 Set 17, 2015
Preventive Controls for Animal Food* Oct. 29, 2013 Set 17, 2015
Produce Safety* Jan. 16, 2013 Nov 13, 2015
Foreign Supplier VerificationPrograms*
Jul. 29, 2013 Nov 13, 2015
Accredited Third-Party Certification Ju. 29, 2013 Nov 13, 2015
Sanitary Transportation of Humanand Animal Food
Feb. 5, 2014 Abr 06, 2016
Intentional Adulteration Dec. 24, 2013 May 31, 2016
*Addi tional proposals published in September 2014
Phase I: Setting Standards
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
20/55
Final Rule on Produce Safety
http://www.fda.gov/fsma
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
21/55
Background - 1
FDA issued proposed rule on Jan. 16, 2013.
Proposed standards for the growing, harvesting,packing, and holding of produce
FDA issued supplemental notice of proposed rulemaking on Sept. 29,2014.
Described FDAs thinking on specific issues relatedto:
coverage of rule, water quality, raw manure, wildlife
conservation, and withdrawal of qualified exemption
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
22/55
Background - 2
Final comment period closed on December 15, 2014Extensive stakeholder outreach and input
Four public meetings; various outreach efforts
About 36,000 submissions, including over 15,000 unique
comments, in response to both 2013 and 2014documents
Input from various sectors of stakeholder community
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
23/55
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
24/55
Regulatory Framework
Framework considers many factors associated withproduce and the farming community, including
Diversity of operations
Broad range of crops and practices
Integrated approach that draws on current scientificinformation, outbreak data, past experiences
Focuses on identified routes of contamination,rather than commodity-based
Includes Current Good Manufacturing Practice-like provisions; numerical criteria; and monitoringprovisions
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
25/55
Produce Rule Documents
Final rule
Qualitative Assessment of Risk (QAR)
Regulatory Impact Analysis (RIA)
Environmental Impact Statement (EIS) and Record of Decision (ROD)
25
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
26/55
Coverage of RuleCovers
Domestic and imported produce
Produce for human consumption
Does not cover
Produce for personal or on-farm consumption
Produce not a raw agricultural commodityCertain specified produce rarely consumed raw
Farms with produce sales of $25,000 per year
Eligible for exemption (with modified requirements)
Produce that will receive commercial processing (kill-stepor other process that adequately minimizes hazards)
Qualified exemption
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
27/55
Farms
Farm definition was revised to clarify that the relevant entity is thefarm business
First defined as part of Implementation of the Bioterrorism Act of 2002,for registration and recordkeeping regulations (21 CFR Part 1,subparts H and J)
27
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
28/55
Primary Production Farm
An operation under one management in one general, but
not necessarily contiguous, physical location
Devoted to the growing of crops, the harvesting of crops, theraising of animals, or any combination of these activities
In addition to these activities, a primary production farm can:
Pack or hold RACs (regardless of who grew or raised them)
Manufacture/process, pack, or hold processed foods so long as:
all such food is consumed on that farm or another farm underthe same management; or
the manufacturing/processing falls into limited categories
28
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
29/55
Secondary Activities Farm
An operation not located on a primary production farmdevoted to harvesting, packing, and/or holding RACs
The primary production farm(s) that grow, harvest,and/or raise the majority of those RACs must own or
jointly own a majority interest in the secondary activitiesfarm
The definition also allows certain, limited additionalmanufacturing/processing, packing, and holding
Same as those for a primary production farm
29
Activities That Do Not Fall
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
30/55
Activities That Do Not FallUnder Farm Definition
Manufacturing/processing that goes beyond activities within the farmdefinition
Examples include:
Pitting dried plums, chopping herbs Making snack chips from legumes
Roasting peanuts or tree nuts
30
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
31/55
Qualified Exemption
Farms are eligible for a qualified exemption (andmust meet certain modified requirements) if:
Less than $500,000 annual food sales; and
Majority of food sales to qualified end-users, i.e., Consumer of the food; or
Restaurant or Retail food establishment located in the samestate or Indian reservation, or located within 275 miles offarm
(The term consumer does not include a business.)
12
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
32/55
Variances - Flexibility
A state, tribe, or foreign country may petition FDAfor a variance from some or all provisions
if necessary in light of local growing conditions
Practices under the variance need to provide thesame level of public health protection as the ruleand not increase the risk that produce is adulterated
13
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
33/55
Alternatives Flexibility
Farms may establish alternatives to certain,specified requirements only
Farm must have scientific information that thealternative provides the same level of publichealth protection as the relevant requirementand does not increase the likelihood of
adulteration
14
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
34/55
Standards for Produce Safety
Focus on conditions and practices identified as potentialcontributing factors for microbial contamination
Agricultural water
Biological soil amendments of animal origin
Worker health and hygiene
Equipment, tools, buildings and sanitation
Domesticated and wild animals
Growing, harvesting, packing and holding activitiesSprouts requirements
34
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
35/55
Agricultural Water - 1
Safe and adequate sanitary quality of waterInspection of water system under farms control
Water treatment, if a farm chooses to treat water
Tiered approach to water testingSpecific microbial criteria for water used for certain
purposes
Corrective measures
Records requirements
16
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
36/55
Agricultural Water-2
Water used during growing activities for produce other
than sproutsFrequency of testing dependent on water source
Lower frequency for untreated groundwater
Higher frequency for untreated surface water
Microbial Water Quality Profile (MWQP)
Initial survey to develop MWQP
Minimum of 2 years, but no more than 4 years
Annual survey to update MWQP using a rolling dataset Re-characterize MWQP under certain conditions
Enables farms to understand their water source to determineappropriate use
36
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
37/55
Agricultural Water - 3
Stringency of microbial criteria is dependent on use:
For activities e.g. post-harvest wash, sprout irrigation No detectable generic E. coli
For growing activities such as non-sprout irrigation
GM of 126 CFU/100 mL or less generic E. coli and STV of 410CFU/100 mL or less generic E. coli
Allows for microbial die-off in-field, between last irrigation andharvest, of up to 4 consecutive days
Allows for microbial reduction or removal post-harvest, including
through commercial practices or storage
37
Biological Soil Amendments
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
38/55
Biological Soil Amendmentsof Animal Origin - 1
Standards for treated and untreatedRestrictions on application method depending on
treatment status
Application-to-harvest interval for certain untreated
BSAs of animal origin is [reserved] Currently working on risk assessment
Processes for meeting treated standard for BSAs ofanimal origin, including two examples for composting
The microbial standards are not testing requirements
38
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
39/55
Training Requirements
Requirements include:
All personnel who contact covered produce orfood-contact surfaces
Establishes minimum content expectationsfor training
Training for supervisors
Record requirements
39
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
40/55
Worker Health and Hygiene
Pathogens may be transmitted from workers to food
Requirements include:
Preventing contamination by ill persons
Hygienic practices Farms must make visitors aware of policies and
give them access to toilet and hand washingfacilities.
40
Equipment Tools Buildings
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
41/55
Equipment, Tools, Buildingsand Sanitation
Requirements include:
Equipment/tools: designed and constructed to allowadequate cleaning and maintenance.
Food contact surfaces of equipment and tools must
be inspected, maintained, cleaned, and sanitized asnecessary.
Buildings: size, design and construction must facilitatemaintenance and sanitary operations.
Toilet and hand-washing facilities must be adequate,and readily accessible during covered activities.
41
Growing Harvesting Packing
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
42/55
Growing, Harvesting, Packing,
and HoldingActivities
Requirements include:
Separate covered and excluded produce not grown inaccordance to the rule
Identify and not harvest covered produce that is reasonably likely
to be contaminated Not distributing covered produce that drops to the ground before
harvest
Food-packing material appropriate for use
42
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
43/55
Domesticated and Wild Animals
Unified requirements for grazing, working, and wild animals:Assess, as needed, relevant areas during growing for
potential animal contamination;
If significant evidence of potential contamination is
found (e.g., animal excreta, animal observation ordestruction),
Evaluate whether covered produce can be harvested
Take steps throughout the growing season to ensure that
covered produce that is reasonably likely to be contaminatedwill not be harvested
43
Impact on Wildlife
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
44/55
Impact on Wildlifeand Animal Habitat
Codified provision (developed in consultation withUSDA's NRCS and the U.S. Fish and WildlifeServices):
Regulation does not authorize taking ofendangered or threatened species; or requiremeasures to destroy animal habitat or excludeanimals from outdoor growing areas
44
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
45/55
Requirements for Sprouts -1
Sprout requirements include:- Treating seed and beans before sprouting
- Testing spent sprout irrigation water (or sprouts, insome cases) for certain pathogens
- Monitoring the growing, harvesting, packing, andholding environment for Listeria species or Listeriamonocytogenes
- Discontinuing use of seeds or beans when spent
irrigation water (or sprouts) is associated with afoodborne illness or a positive pathogen finding
45
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
46/55
Requirements for Sprouts - 2
Significant changes in final rule include:
Staggered compliance dates based on operation size begin 1 year aftereffective date of the rule; no additional time for water provisions
Exclude soil- or substrate-grown sprouts harvested without their roots
Criteria established for spent irrigation water testing to account for
emerging pathogensEstablish a written sampling plan and a corrective action plan for
testing of spent irrigation water (or sprouts)
New provisions to prevent contaminated product entering commerce(incl. hold-and-release -- must not allow sprouts to enter commerce
until negative pathogen testing results are received)
46
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
47/55
Staggered Compliance Dates
47
* Farms with
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
48/55
Environmental Impact Statementand Record of Decision
EIS assessed potential environmental impacts of therule
- Final EIS considers public comment on Draft EIS.
- Potentially significant impacts identified on groundwater
and soil subsidence (resources already significantlyimpacted).
- Evaluated potential environmental impacts of thoseprovisions designed to fulfill FDAs public health goals
ROD considers decisions in the rule and identifiesagency-preferred alternative for each potentiallysignificant provision
48
C t d B fit
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
49/55
Costs and Benefits
Annualized benefits (at 7%) of avertingapproximately 331,964 produce-related illnesses= $925M ($976M at 3%)
Annualized costs (at 7%) = $366M ($387M at 3%)
49
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
50/55
Guidance
Implementation and Compliance Guide
Sprout Guidance
Small Entity Compliance Guide
Updated GAPs Guidance
50
Education Outreach Training and
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
51/55
Education, Outreach, Training andTechnical Assistance Partnerships
Alliances
Produce Safety Alliance
Sprout Safety Alliance
Food Safety Preventive Controls Alliance
FDA/USDA-NIFA Collaboration: National FoodSafety Training, Education, Extension,
Outreach, and Technical Assistance ProgramTraining through Cooperative Agreements
51
FDAs Role in Education Outreach
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
52/55
FDA s Role in Education, Outreach,Training, and Technical Assistance
FDA Guidance documents
National Technical Assistance Network
Information Center
Partnerships will be essential
34
F M I f ti
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
53/55
For More Information
Web site: www.fda.gov/fsma
Subscription feature availableTo submit a question about FSMA, visit www.fda.gov/fsma and go to
Contact Us
53
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
54/55
Thank you very much foryour attention!
54
-
7/25/2019 Implementation Status Fsma Final Rule Produce Safety
55/55
top related