FDA & OSHA – New Reforms & Standards Affecting the Industry
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Transcript FDA & OSHA – New Reforms & Standards Affecting the Industry
2013 TLMI Technical Conference
FDA & OSHA – New Reforms & Standards
Affecting the Industry
Session Chairs: David Dickerson, Rick Fox
Jeff Barach, PhD– Barach Enterprises
Jeffrey Barach, PhD is a food scientist that has
been active in research and development,
regulatory liaison activities, teaching, problem
solving and trouble shooting. He routinely
participates in planning, development and
management of special projects and programs for
the food industry on health and safety issues,
production of foods, regulatory compliance issues
and training. He is a subject matter expert (SME)
on issues related to food safety modernization,
biotechnology, food irradiation, nanotechnology and
other new processing and testing technologies .
Danielle Gallo – Brady Corporation
Danielle Gallo is a Senior Product Marketing
Specialist for Brady Worldwide, Inc. She manages
Brady’s safety and facility identification products for
industry regulatory compliance and safety
concerns. She is active in developing new products
and solutions for the industry, as well as monitoring
ever-changing regulations and global standards.
Brady Worldwide, Inc. is an international
manufacturer and marketer of complete solutions
that identify and protect premises, products and
people, including products in high-performance
labels and signs, safety devices, printing systems
and software, and precision die-cut materials.
2013 TLMI Technical Conference
FSMA Will Bring Added Demands on Food
Safety Systems: Is Packaging Ready?
TLMi Conference
Chicago, IL
September 5, 2013
Jeffrey Barach, Ph.D.
Presentation Outline
FSMA Background
FSMA Current Status
Risk Assessment and Preventive Controls
Food Safety Plan
CPG Companies – Be Prepared
Packing/ Processing Companies- Be
Proactive
Summary
Proposed Rules – cGMP & Preventive Controls
Key Provisions
Reaffirms Industry’s Role in Food Safety
Prevention vs. Reaction
Risk-based Decisions
Summary of Requirements
Conduct a Hazard Analysis and Assign Riskbased Preventive Controls
Develop a Written Food Safety Plan
Follow Updated cGMPs (Part 110 -> Part 117)
Compliance Based on Company Size (1-3
years)
FSMA Status Summary
Today
• Mandatory Recall
Authority
• Records Access
• Preventive
Controls - Human
• Produce Safety
• Traceability
Tomorrow
• Preventive
Controls –
Animals & Pets
• FSVP
• 3rd Party
Accreditation
• VQIP
• Food Defense
FDA’s Proposed Timeline
Regulation
Proposed Rule
Publication
Final Rule Publication
Preventive ControlsHuman Food
January 16, 2013
May 1, 2014
Preventive ControlsAnimal Food
August 31, 2013
May 1, 2014
Produce Safety
January 16, 2013
May 1, 2014
Foreign Supplier
Verification Program
August 31, 2013
May 1, 2014
Accreditation of 3rd
Party Auditors
August 31, 2013
May 1, 2014
Food Defense
August 31, 2013
May 1, 2014
Filed with US District Court/ Northern CA – CFS & CEH vs. FDA; June 2013
Planning Ahead for FSMA
The most significant food safety reform in
70 years.
Focuses on the prevention of problems that
could lead to foodborne illness or injury.
√ Be Prepared
Proactive
√ Be
Get Started and Don’t Wait !
FSMA is 85% HACCP- We Know HACCP!
FDA Needs to write 50 Rules & Guidance Documents
First Rules will be Proposed Rules and/or Draft
Guidance
120 Day + 120 DAY (8 Months!) Comment Period
Several Months for FDA to Respond to Comments
Final Rules and Guidance will Need to be Published
Implementation- many months
Compliance-will be years (2015?)
Be Prepared
• Update Food Safety and Food Defense Plans
- Hazard analysis
- Preventive controls
- Verification, including testing
• Update Supply Chain Management Programs
- Domestic
- Foreign
• Review Records Maintenance & Access
Procedures
- Routine
- Under Bioterrorism Act
Be Proactive
Ensure Your Food Safety “Qualified
Individual” is Engaged Now
Develop a Plan for Transition
– GMP → “HACCP” → FSMA
– HACCP → FSMA
Upgrade Capabilities – Invest for the Future
– Record Keeping and Track/Trace
– Validation of Processes
– Allergen Management Programs
FSMA – Composition Overview
Food Safety Assurance Pyramid
Total
Management
Commitment
HACCP
FSMA
Preventive
Controls
Education
and
Training
Biological,
Chemical, and
Physical Hazards
Food
Cleaning
Temperature
and
Control
Sanitizing
Food Defense
HACCP
Personal
Pest
Hygiene Management
Produce Safety
Graphic by Robert B. Gravani
PrP’s
HACCP – Hazard Analysis & Preventive Controls
Covers 3 types of potential food safety hazards:
Biological
Chemical
Physical
Hazards may be naturally occurring in food, contributed by
environment, or generated by a mistake during processing
FSMA adds Radiological hazards
Sources of Hazards
Raw Materials and/or Ingredients Used in
the Product
Activities Conducted at Each Step in the
Process
Equipment Used to Make the Product
Packaging and Packaging Material
Storage and Distribution
Intended Use (Misuse)
Consumers of the Product (Population)
Food Safety Plans
Seafood, Juice (FDA)
Meat & Poultry (USDA)
Domestic & Foreign
Human Foods &
Animal Foods (FDA)
FSMA: Building a Food Safety System
Process
Controls
(CCPS)
Hazard Analysis
Defines: Hazards
and Preventive
Controls
Parameters
& Limits
Monitoring
Recall
Plan
Records
Allergen
Hazard
Controls
Verification
Corrective
Actions
Sanitation
Hazard
Controls
General Controls: Prerequisite Type Programs
GMPs, SSOP, Supplier Controls, Food Defense
and Others
Barachby
Enterprises
LLC
GRAPHIC
BARACH ENTERPRISES
LLC
Company
ABC’s:
Food
Safety
Plan
Foundational
Food Safety
Programs
(SOPs)
Key Criteria for Food Equipment Sanitary Design
Minimize Surface Area to Clean
Parts and Assemblies Easy to Access and
Inspect
Disassembly Can be Completed by Hand or
With Simple Tools
Cleaning and Sanitizing Procedures Can be
Repeated by All Responsible Employees
GMA Equipment Sanitary Design
Checklist for Low-Moisture Foods
Assist in evaluating compliance with the GMA Ten
Principles for Sanitary Design for low-moisture foods
Satisfactory -All
Marginal – ½ Points
Unsatisfactory – No Points
Validation: Today & Tomorrow
Traditionally, validation has encompassed
scientific or technical support indicating a
HACCP plan will effectively control targeted
hazards (CCPs)
As required by FSMA, FDA may expand the
validation requirements to include more
scientific and in-plant validation proof
including validation of equipment, processes
and programs
Opportunities with Equipment Manufacturers
Equipment Design and Construction
Sanitation Practices
Allergen Management
Environmental Monitoring
Temperature Monitoring
Validation
– Scientific Support & In-plant Validation
Employee Training
Records and Traceability
Working Together on FSMA
Ingredients
Product
Properties
(Risk)
Packaging
Labeling
Water
Air/
Environment
People
Finished Product
Processing
& Controls
Equipment
Design &
Cleaning
Design Ideas – New and Retrofit Equipment
If you can’t see it you
can’t clean it!
Provided by Triangle Package Machinery Co.
Key Criteria for Food Equipment Sanitary Design
Minimize Surface Area to Clean
Parts and Assemblies Easy to Access and
Inspect
Disassembly Can be Completed by Hand
or With Simple Tools
Cleaning and Sanitizing Procedures Can
be Repeated by All Responsible
Employees
Find the Sanitary Design Problems…
1) 4-Bolt Ball
Valve: Difficult
to Clean and
Disassemble
2) Capped Ferrule:
Provides a
Dead-end
3) 1” Drain Line is
Dead-end
Equipment Photos by Tom Fishlove,
General Mills-Sanitation Center of Excellence
Pack Expo 2012
Avoid a Ledge Where Product Can Build Up
Equipment Support/Leveling Pads The Good and the Not So Good
Internal Threads, O-Rings &
Hygienic Finish
Exposed Threads
Example of Equipment with Tool-Less Disassembly -No Need to Use Tools that May be Misplaced or Lost
Future Education & Technical Assistance
Alliances
FDA - National Technical Assistance Network &
Information Center (Phone/Emails)
FDA Contract on Guidance
– Deloitte and Touche
– Institute of Food Technologists
– Leavitt Partners
GMA – FSMA Manual & Webinars
Others
Your Resource
for Packaging
and Processing
Innovation
31
Questions ?
Contact:
[email protected]
703-242-9377
www.jbarach.com
2013 TLMI Technical Conference
TLMI Technical Conference
Danielle Gallo
OSHA’s modification of the Hazard Communication Standard
(HCS) and it’s alignment with the Globally Harmonized System of
Classification and Labeling of Chemicals (GHS)
About the Presenter
Brady Worldwide, Inc. is an international
manufacturer and marketer of complete
solutions that identify and protect premises,
products and people, including products in
high-performance labels and signs, safety
devices, printing systems and software, and
precision die-cut materials.
Danielle Gallo is a Senior Product Marketing
Specialist for Brady Worldwide, Inc. She manages
Brady’s safety and facility identification products for
industry regulatory compliance and safety concerns.
She is active in developing new products and
solutions for the industry, as well as monitoring
ever-changing regulations and global standards.
Hazard Communication Standard
Initially developed in 1983 to give employees a
“right to know”
Requires a comprehensive hazard evaluation
and communication process
Chemical manufacturers and importers must
develop and provide a container label and a
Material Safety Data Sheet (MSDS).
Employers with employees exposed to
hazardous chemicals must develop a hazard
communication program including:
Labels
Access to SDSs
Training on the workplace hazardous
chemicals
The previous HCS established requirements for
minimum information that must be included on
labels and SDSs, but did not provide specific
language to convey the information or a format in
which to provide it.
Background of GHS
Why the need?
Country-by-country, around the globe, hazard classification and communication
laws are similar in purpose, but different enough to result in inconsistent hazard
classification for similar products, and dissimilar looking labels and SDS.
Need to harmonize and improve safety information and facilitate international
trade through compatible classification methods, SDS and labels.
NFPA RTK - US
HSID Std - Europe
WHMIS Std – Canada
Background of GHS
United Nations Conference on Environment and Development (1992)
mandated a globally harmonized chemical classification and
labeling system
– Member States actively involved in creation:
Unites States (OSHA representatives)
Canada
European Union
Additional UN Members
GHS was formally adopted in 2002
– United Nations Committee of Experts on the Transport of Dangerous Goods
– Globally Harmonized System of Classification and Labeling of Chemicals
Goal of GHS
– Written by the UN, the goal of the GHS is to harmonize differing workplace
hazard classification and labeling systems across the world
How GHS accomplishes that goal
– Harmonizes how hazardous substances and mixtures are classified
– Changes how hazard information is communicated
(new pictograms and phrases)
– Streamlines the format of SDS and labels
What is GHS?
NFPA RTK - US
Globally-Standardized GHS Std
WHMIS Std – Canada
HSID Std - Europe
GHS Status in Americas
United States – adopted by OSHA as of May 2012
Canada – Reviewing for development:
–
–
–
Health Canada Policy and Programme Services Office is national coordinator.
Currently reviewing GHS for incorporation into WHMIS
Estimated changes to WHMIS occurring in Spring 2013
Mexico – Voluntary standard proclaimed:
–
–
–
–
–
–
The first NAFTA member to adopt the GHS as a basis for national health & safety
regulations
Proclaimed a new voluntary standard, NMX-R-019-SCFI-2011 (June 4, 2011).
NOM-018-STPS-2000 remains in force.
Dual labeling & SDS’s result
Companies importing/ exporting products to and from countries in Europe, Asia &
South America are required to comply with both NOM 018-STPS-2000 & GHS
ANIQ (Associacion Nacional de la Industria Quimica) requested authorization from
the Labor Secretariat for an alternate procedure to comply with NOM 2000 through
the GHS NMX-R
Brazil – Implemented for substances:
–
–
Pure substances (GHS classification, labeling & SDS) mandatory as of Feb 2011.
Mixtures mandatory as of June 1, 2015
GHS Status in Europe
& Around the Globe
27 EU Countries – Implemented under Regulation 1272/2008
–
–
–
CLP is mandatory for 4,500 SUBSTANCES as of December 1, 2010
CLP will be mandatory for all MIXTURES on June 1, 2015
2ND technical adaptation; Regulation 286/2011
Australia: Implemented (Dec. 2016 deadline)
China: Implemented
Japan: Implemented
67 countries globally - at least partially implemented:
–
See UN website: http://live.unece.org/trans/danger/publi/ghs/implementation_e.html
OSHA’s Final Ruling on GHS
OSHA has updated its Hazard Communication Standard (HCS) to align
with the United Nations’ Globally Harmonized System of Classification
and Labeling of Chemicals (GHS).
Modifications will reduce costs and burdens while protecting employers
and employees.
Modifications include:
Revised criteria for classification of
chemical hazards
Revised and standardized labeling
requirements
A specified format for safety data sheets
Requirements for employee training on
labels and safety data sheets
Based off of the 3rd revised edition of GHS.
Impact of GHS for U.S. Businesses
880,000 hazardous chemicals are
currently used in the U.S.
Hazard Communication affects 43 million
American workers in over 5 million
workplaces.
GHS will prevent 500 injuries/illnesses and
43 deaths per year, equaling a total of
$250 million in reduced health and
safety risks.
Costs per year will total $201 million
dollars to comply with revisions to
the HCS.
Future net benefits are estimated at $556
million dollars per year.
U.S. Dept. of Labor, OSHA, Directorate of Evaluation and Analysis
Office of Regulatory Analysis, 2011.
5 Main Requirements For a Complete
Hazard Communication Program
1. Written Hazard Communication Plan
2. Chemical Inventory
3. Labels & Warnings
4. Safety Data Sheet Documents
5. Employee Training
Written Hazard Communication Plan
1. Written Hazard Communication Plan
The starting point; your current plan:
Blueprint for implementation
Written plan that identifies how all requirements
will be met, including:
labels and other forms of warning
safety data sheets (SDS)
employee information and training
Review your current plan with the revised,
published rule in-hand
OSHA Model Hazard Communication Plan
Written Hazard Communication Plan
(continued)
Model Hazard Communication Program
1.
2.
Company Policy
To ensure that information about the dangers of all hazardous chemicals used
by (Name of Company) is known by all affected employees, the following
hazardous information program has been established.
3. Container Labeling – Revise & Train
4. Safety Data Sheets (SDSs) – Revisions. Obtain & Train
5. Employee Training and Information – Update
6. Hazardous Non-routine Tasks
7. Informing Other Employers/Contractors
8. List of Hazardous Chemicals – Update Your Inventory
9. Chemicals in Unlabeled Pipes
10. Program Availability
A copy of this program will be made available, upon request, to employees and
their representatives.
OSHA Model Hazard Communication Plan
Chemical Inventory
2. Chemical Inventory
Review your chemical inventory:
Prepare list of chemicals
Survey the workplace for chemicals:
solids/liquids/gases/fumes
Check both the hazardous nature and
potential for exposure
Check for updated SDS’s
New chemical receipts
Chemical purging
SDS management for both
Attach chemical list to written program
*Your chemical inventory should be reviewed
annually
Chemical Labels and Warnings
3. Labels & Warnings
Update the labels and warnings section of written program:
– Process and execution for container labeling
– Worn, missing and unreadable labels are replaced as needed
Check secondary container labels for consistency with the:
– Revised HazCom regulation
– Revised labels on containers being received
Label identities should link to the SDS & chemical inventories
Check warning signs & labels for OSHA Subpart Z-Toxic &
Hazardous Substances. Many may be revised; eg § 1910.1027
Cadmium
GHS Pictograms
Health Hazard
Flame
Exclamation Mark
Carcinogen
Mutagenicity
Reproductive Toxicity
Respiratory Sensitizer
Target Organ Toxicity
Aspiration Toxicity
Flammable
Pyrophorics
Self-Heating
Emits Flammable Gas
Self-Reactive
Organic Peroxides
Irritant (skin and eye)
Skin Sensitizer
Acute Toxicity (harmful)
Narcotic Effects
Respiratory Tract Irritant
Hazardous to Ozone Layer (Non
Mandatory)
Gas Cylinder
Corrosion
Exploding Bomb
Gases Under
Pressure
Skin Corrosion / Burns
Eye Damage
Corrosive to Metals
Explosives
Self-Reactives
Organic Peroxides
Flame over Circle
Skull and
Crossbones
Environment
(Non Mandatory
per OSHA)
Oxidizers
Acute Toxicity
(Fatal or Toxic)
Aquatic Toxicity
GHS Pictograms
Chemical/Physical Risks
1. Explosives
2. Flammables
3. Oxidizers
4. Gases Under Pressure
5. Corrosives
Chemical Risks Pictograms
Health Risks
1.Severe Toxics
2.Acute Toxics
3.Health Dangers
4.Corrosives
Health Risks Pictograms
Environmental Hazard Class*
*OSHA does not regulate the
Environmental Hazard Class, however
the EPA is expected to incorporate this
element of GHS into their standards.
Changes to the HazCom Label
Six Elements of the GHS label format
Hazard & Precautionary Statements
Hazard Statements
Physical (H200 series codification) – Appendix B
H200 unstable explosive
H221 flammable gas
Health (H300) – Appendix A
H300 fatal if swallowed
H301 toxic if swallowed
Environmental (H400) – EPA
H400 Very toxic to aquatic life
Precautionary Statements
General (P100) – P102 Keep out of reach of children
Prevention(P200) – P235 Keep cool
Response (P300) – P380 Evacuate area
Storage (P400) - P403 Store in a well-ventilated place
Disposal (P500) – P502 Refer to manufacturer for information on
recycling
Federal Register 9_30_09
Benefits of a GHS-formatted Label
Provides immediate visual reminders
of hazards
Past labels were inconsistent in
terminology and visuals
Standardized signal word, visuals,
and hazard statements are in place
Pictograms reinforce message
presented in the text while enhancing
communication for low-literacy users
Precautionary statements provide
useful steps to protect and prevent
from chemical related injuries
Example of Multi-Language Label
GHS Label Layouts on Packaging
Outer Packaging: Box with a
flammable liquid transport
label*
Inner Packaging: Plastic bottle
with GHS hazard warning label
From GHS Purple Book.
* Only the UN transport markings and labels are required for
outer packaging.
GHS Label Layouts on Packaging
From GHS Purple Book
Secondary Container Labeling
What is it?
–
–
“Secondary container” is defined as any container being used beyond
the original manufacturer’s bottle that the chemical was shipped in
This may include:
Portable or working containers
Storage bottles that are created for distribution of smaller amounts of the
chemical
Do I need to label it? What does it need to say?
Portable/Working Containers
–
–
YES! The only time it does not need to be labeled is if the container is
intended only for the immediate use of the employee who performs the
transfer
The label needs to:
Identity of the hazardous chemical
Identify appropriate hazard warnings (words, pictures, symbols or a
combination)
Provide the employees with the specific information
regarding the physical and health hazards of the
hazardous chemicals
NFPA 704 and HMIS Systems
There are currently no plans to change the
existing NFPA 704 and HMIS Systems and
Classification
These systems will still be used primarily to
convey hazardous information to emergency first
responders
Classification Differences between
NFPA and GHS
HMIS/NFPA Hazard Ratings
GHS Hazard Categories
0 = Minimal Hazard
Category 1 = Severe Hazard
1 = Slight Hazard
Category 2 = Serious Hazard
2 = Moderate Hazard
Category 3 = Moderate Hazard
3 = Serious Hazard
Category 4 = Slight Hazard
4 = Severe Hazard
Category 5 = Minimal Hazard
Where will I see those differences?
The GHS hazard categories are displayed in the chemical’s Safety Data Sheet
and not typically shown on the label
Due to the significant change in classifications, it will be
imperative to train employees on the change to ensure there
is no confusion or conflicting information given
Sample Chemical Label in Both
Systems
Sample Chemical Label in Both Systems
Butanone Chemical
Hazard Information in SDS
Flammability
Category 2
Flammability
Category 3
*Information excerpted from Sigma Aldrich Butanone MSDS, revised 05/08/2012
Secondary Container Labels
Best Practice: Label your secondary container
chemicals with the same GHS format as the way they
came into the facility
Best Practice: Use a dual-labeled approach to where
you show both your NFPA/HMIS label alongside the
GHS label
Employers may choose to label workplace containers
– With the same GHS label that is used to ship containers under the revised rule,
– With label alternatives that meet the requirements for the standard
National Fire Protection Association (NFPA) 704 Hazard
Rating and the Hazardous Material Information System
(HMIS) for labeling are considered acceptable for
workplace containers
– Information supplied on these labels must be consistent with the revised HCS (e.g. no
conflicting hazard warnings or pictograms)
Safety Data Sheets
4. Safety Data Sheet Documents
Check your safety data sheets (SDSs) against your chemical inventory
Do you have an (M)SDS for each chemical in your inventory?
Do you have SDSs for other chemicals?
Have duplicates and obsolete SDSs been removed?
Contact chemical suppliers to receive or learn when they will begin
supplying SDS’s according to the new format
Are the SDSs readily accessible to employees?
Safety Data Sheet Changes
New SDS Order and Elements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Identification of the substance or
mixture and of the supplier
Hazards identification
Composition/information on ingredients
First aid measures
Firefighting measures
Accidental release measures
Handling and storage
Exposure controls/personal protection
Physical and chemical properties
Stability and reactivity
Toxicological information
Ecological information**
Disposal considerations**
Transport information**
Regulatory information**
Other information including information
on preparation and revision of the SDS
GHS harmonization will
standardize the order of SDS
information for ease of use for
employees along with improved
accuracy of the information
presented
Previously know as Material Data
Safety Sheets (MSDS), it is now
referred to as Safety Data
Sheets (SDS).
The number of sections has been
increased from a nine section
format to 16 sections.
**sections are not required in final rule but suggested by original U.N.
GHS publication and may be added by employers
So Who’s Responsible?
Hazard Classification
– Chemical manufacturers analyze existing formulations and re-classify products to new GHS
standards
Chemical Labels
– Chemical manufacturers update primary container product labels to meet GHS standards and
distribute upon purchase
– Employers update secondary container labels and ensure all chemicals in the facility are clearly
labeled and marked
Safety Data Sheets (SDS)
– Chemical manufacturers update all SDS to new 16-section format and distribute to customers
– Employers ensure updated SDS are made available to all employees on-site
Employee Training
5. Employee Training
OSHA has not proposed to change training provisions under the
HCS other than to initially train employees on new GHS
elements.
Minor revisions to the HCS on training:
– Labels and SDSs must be adequately explained to employees.
– Employees must understand standardized headings and sequence of SDS information.
– Training on the standardized label elements must also be given.
HCS training is meant to explain and reinforce information to the employees
on areas of labels, SDSs, protective measures to be taken, and the
understanding of chemical hazards in their workplace.
Training is crucial! A study found employees did not understand 1/3 of
the safety and health information with MSDSs, while 40% of
individuals reading an MSDS had an overall difficulty understanding.
General Elements of HazCom/GHS
Training
1. Understanding the new Hazard Communication
Standard
2. Understanding the Safety Data Sheet
3. Understanding Labels
Pictograms
Signal Words
Hazard Statements
Precautionary Statements
4. Understanding relationship of SDS and label
5. Understanding health information
GHS Transition Timeframe
December 1, 2015:
Chemical distributors
shipping product with
updated SDS’s, and
chemical labels
December 1, 2013:
Deadline to initially
train employees on
new label elements
and SDS formats
June 1, 2015:
June 1, 2016:
Chemical
manufacturers
reclassify chemicals,
send SDS’s, and
update chemical
labels
Full GHS
Compliance: hazard
communication
program and
workplace labeling
updated
Today
2013
2014
2015
2016
Getting Ready for GHS
Take immediate action on:
1.
2.
3.
4.
Staying alert for newly formatted SDS’s and capture them on file
Update your chemical inventory
Talk to our chemical supplies about their transition plans
Chemical manufacturers and importers should begin preparing
for/authoring GHS compliant SDS’s and labeling
Coming up you will need to:
1. Be informed on regulation guidelines by December 1, 2013
2. Begin implementing GHS by the specified timeframe by December 1,
2013
3. Train your employees on GHS by December 1, 2013
In the future be prepared to:
1. Confirm that your secondary labeling system is GHS compliant. Use
updated (GHS) labeling software to create and produce your labels
by June 1, 2016
Hazard Communication and GHS
What you need to know to prepare for the 2013 deadline