OSHA Safety Data Sheets (SDS)… formerly known as MSDS… what do employers need to do?

“The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), revised in 2012, requires that the chemical manufacturer, distributor, or importer provide Safety Data Sheets (SDSs) (formerly MSDSs or Material Safety Data Sheets) for each hazardous chemical to downstream users to communicate information on these hazards.” The link below is an OSHA publication that explains the 16 part form of an SDS and is an important training tool for users of these documents.

https://www.osha.gov/Publications/OSHA3514.html

Employer Responsibilities

Employers must ensure that the SDSs are readily accessible to employees for all hazardous chemicals in their workplace. This may be done in many ways. For example, employers may keep the SDSs in a binder or on computers as long as the employees have immediate access to the information without leaving their work area when needed and a back-up is available for rapid access to the SDS in the case of a power outage or other emergency. Furthermore, employers may want to designate a person(s) responsible for obtaining and maintaining the SDSs. If the employer does not have an SDS, the employer or designated person(s) should contact the manufacturer to obtain one.

How does CFD facilitate the collection of information?

Our website includes a link to SDS forms for most products we sell and we are working on updating this information for all products that require them. The following is an example of the location on our website:

As you approach the requirement to create a Feed Safety Plan one of the things you will need to do is to identify and address ingredient hazards. Collecting Product tags and SDS may be a way to satisfy two requirements in one. This is something you could start in the coming months in preparation for creating the plan.

 

FSMA Animal Food cGMP inspections have begun…

The following is an update CFD received from AFIA regarding inspections…

AFIA learns FSMA CGMP inspections are under way

Last fall, the Food and Drug Administration provided an update on its plans for investigator training for the “Current Good Manufacturing Practice and Hazard Analysis Preventive Controls for Animal Food” (PCAF) final rule inspections. The strategy is to develop a 30-person investigator cadre from FDA’s Center for Veterinary Medicine and Office of Regulatory Affairs and state regulators from 10 different states, who will conduct the first inspections, and in turn, train the rest of the inspectors. This 30-person inspector cadre will perform the majority of CGMP inspections during the first year of compliance.

Investigators are required to attend the 20-hour Food Safety Preventive Controls Alliance (FSPCA) training for preventive controls qualified individuals (PCQI), as well as an additional FDA regulatory training course prior to conducting any PCAF inspections.

FDA’s intention is to conduct CGMP compliance inspections only with “large” businesses in fiscal year 2017. A large business is defined in the final rule as a business employing 500 or more full-time equivalent employees. It’s important to note that FDA has stated not all “large” businesses will be inspected in FY2017, and the focus of the initial inspections will be on education, training and technical assistance to help companies comply with the new requirements.

The American Feed Industry Association learned [in mid-February] that one of the first CGMP inspections was conducted at a member facility in Georgia. The federal investigator was from FDA’s Atlanta District Office and had a list of facilities in the investigator’s area to inspect. During the inspection, the investigator emphasized to the plant manager the purpose of the inspection was focused on education at this point rather than compliance. Below is a summarized list of items that were asked for or discussed during the inspection:

  • Asked questions related to the size of the company
  • Asked for documentation of qualified individual training
  • Asked whether the facility has CGMPs in place
  • Asked whether the facility has conducted a hazard analysis
  • Asked whether the facility has a written animal food safety plan prepared
  • Asked whether the facility has an environmental monitoring program
  • Asked whether the facility has a recall plan
  • Asked whether the facility is an importer
  • Asked to see facility job descriptions
  • Asked questions pertaining to PCQI qualifications
  • Conducted a thorough walk-through of the plant to observe CGMP compliance

The investigator was clear to state that all of the questions were not related to actual current Food Safety Modernization Act requirements for the facility. The goal was to get a better understanding about where the facility is on its journey.

In addition to the official Notice of Inspection, the plant manager was left with FDA Fact Sheets on Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule (animal food is exempt from this regulation), Preventive Controls for Food for Animals Final Rule and Sanitary Transportation of Human and Animal Food Final Rule. The plant manager was told he would receive a full written report on the inspection at a later date.

AFIA notes many of the questions asked by the investigator are not related to the CGMP requirements. FDA appeared to be gauging the overall understanding of the final rule by plant management. For instance, no facility in a firm of more than 500 employees is required to have a recall plan until September of this year and only if that facility has one or more preventive controls. However, the facility did need to have records documenting qualified individual training, as that is required of first-year compliance facilities.

 

Used with permission by AFIA.

Veterinary Feed Directive Training Tools

January 1, 2017 marked the beginning of an expanded list of drugs that fall under VFD regulation. Click here to watch an FDA’s overview video on this rule and its importance to the industry.

CFD’s membership in AFIA affords us the opportunity to offer our membership valuable training tools offered to AFIA members.  Due to high demand, AFIA created a training module on VFD preparedness, which targets retail distributors (i.e. farm stores and co-ops), something previously unavailable.

  • Click here to watch the AFIA youtube training video.
  • Click here for an example of a completed VFD.

 Used with permission by AFIA.

FDA focus and plans for FSMA inspections…

Large companies (more than 500 employees) were required to be in compliance with the first parts of the rule in September 2016. What did that mean in terms of FDA inspections? As one might expect, it has been a slow start and there have not been inspections to date. The FDA is focused on training inspectors (31 had been trained as of early December 2016). They are working with states to contract inspections as well and we expect that New York and Pennsylvania will do so. So what are they doing? FDA Consumer Safety Officer Jenny Murphy spoke at a conference held by AFIA in Arlington, VA in early December. She spoke about the inspection efforts by the FDA and what to expect moving forward.

Key points made:

  • Only inspections in FY17 will be for compliance with CGMPs for “large” businesses
  • Other facilities that get inspected (for BSE or medicated feed CGMPs) can expect to be asked FSMA readiness/awareness type questions. Answers are voluntary but very helpful to FDA staff.
  • Inspections expected to start January 2017
  • FDA will NOT inspect all “large” businesses in first year

She answered the following questions:

  • Does the focus on education mean the FDA will NOT hold companies to these standards right away? No, while the focus is on education a public health threat will move inspections to action.
  • What is the best thing a facility can do to prepare? Take the intent of the rule to heart, look at big picture and look past the regulation… Document, document, document!
  • Where can companies go wrong in preparing? By putting the focus on passing the inspection and NOT putting food safety in the forefront.
  • What is the ultimate goal of the FDA? The ultimate goal is food safety and public health.

Preparing Producers and Feed Sales Staff for VFD

On Jan. 1, 2017, certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter to Veterinary Feed Directive (VFD). The American Feed Industry Association supports the judicious use of antimicrobial drugs and is working to ensure members are prepared for the upcoming change. AFIA is notifying members of new resources available to help ensure all groups are fully prepared to comply with the VFD rule.

Through recent efforts within the industry, there have been many resources and trainings for veterinarians and feed distributors. Much of this information has not been disseminated to the small producers and feed distributors, however. The Farm Foundation, NPF has partnered with the Animal Health Institute (AHI) to develop educational resources for producers, feed distributors and veterinarians. The first resource is a website containing educational materials from various sources.

The Farm Foundation and AHI have a campaign to inform farmers and ranchers of the pending changes. Information is disseminated through a series of informational radio interviews circulated through the news service of the National Association of Farm Broadcasters.

A point-of-sale card has been created, which is designed to alert producers of the Jan. 1, deadline and the need to prepare. The card refers people to the website for more detailed information. It can be placed in the feed section and/or at a checkout counter and is available in three formats:

  1.   Prints one card
  2.   Print two cards per page

Word file of the information, to which the retailer can add a company name and/or logo; can also be copied into an email message.

Used with permission by AFIA.

VFD is just around the corner…

CFD recently sent information on requirements for FDA notification and supplier acknowledgements. There are a number of information sessions being conducted by various organizations. When members have attended those they have provided additional information to CFD and we appreciate that… The following is noteworthy…

  • Documentation required for a VFD can only be stored electronically when in compliance with Federal Rules known as Part 11. This is essentially a secured server environment. CFD recommends that all documentation be maintained on paper initially. AFIA is working with the FDA to eliminate this mandate and we will keep you posted.
  • VFD cannot provide for automatic refills. The time period is limited to 6 months.
  • Pulsing regiments are not permitted.
  • To use Bovatec in conjunction with a VFD drug the VFD must include that direction.
  • Record retention requirements for documentation vary by state. Federal requirements are 2 years.

Facility Registration Under Bio-terrorism Act

Action Required – FDA Biennial Registration due October 1, – December 31, 2016

The Bioterrorism Act of 2002 requires all Food (Human and Animal) facilities to register with the FDA. In 2011 FSMA changed the registration requirements from one-time registration to every two years in even years between Oct 1 and Dec 31. Failure to register is a federally prohibited act.

It has been CFD’s position that most members (and many customers) must register! Each facility under company ownership that has a different address requires registration. There are exceptions to the registration requirements. In the future the FDA will allow for cancelling registrations (#6 below) based on its verification that a facility is not required to register. If a member has any questions regarding the requirement to register, it may be safer to register and let the FDA exempt one or more of your facilities than to not register.

Between October 1, 2016 and December 31, 2016 go to: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm

During registration some of the information you will be required to provide includes the following:

  • The e-mail address for the contact person of the domestic facility
  • Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
  • Updated food product category information, as determined appropriate by FDA in already-published guidance

Changes to the rule will be implemented in the coming years (there are many but these apply to our members):

  1. Unique Facility Identifier (UFI) – Will be assigned by the FDA and assist the FDA in verifying accuracy of site specific address, the FDA will verify the UFI prior to issuance of registration number or confirmation of registration. This will be implemented October 1, 2020.
  2. If you use a 3rd party to do your registration, the email of owner, operator, or agent in charge who authorized a third party to act on behalf of the facility will be required.
  3. Some previously optional fields are now mandatory. Such as preferred mailing address, emergency contact email address, type of activity.
  4. Electronic registration will be required as of January 4, 2020 (Changes to the waiver of electronic registration will also being made).
  5. Abbreviated Registration Renewal Process
  6. The FDA will have authority to cancel registrations in additional circumstances (such as: FDA independent verification that a facility is not required to register, facility address not updated in a timely manner, unauthorized registration submissions, registration expiration due to failure to renew.
  7. Requirement for immediate update to incorrect registration information
  8. Changes to activity types (such as Farm Mixed-Type Facility, Animal food warehouse/holding facility).

The FDA is preparing guidance on some of these changes and as more information is available we will provide updates!

FSPCA Preventive Controls for Animal Food Introduction

I am a lead instructor for this course (Certificate#2ca42a12). Below are chapter summaries from this very important training. This training is recognized by the FDA as one way to become a Preventive Controls Qualified Individual (PCQI). As an instructor I feel it is an excellent way to become fully versed in the rule and obtain training necessary t implement the rule. I encourage owners, operators, agents in charge of a facility and the person to be designated as the facility PCQI to attend this training.

This class is highly interactive and each chapter has exercises and in some cases small group activities. You will not complete a FSP for your facility during this class but you will gain the knowledge on how to do so when you return to your facility.

Chapter 1

Regulatory Overview and Introduction to the Rule – This chapter goes over Sub Parts A, D and F in detail. It addresses important definitions and roles, the training requirements of the rule, exemptions and records requirements.

Chapter 2

Current Good Manufacturing Practice – This chapter defines the purpose and importance of cGMP’s. It explains the basic requirements of the 8 cGMP’s, which are the baseline standards required to manufacture safe feed. They provide the foundation on which you will write you Food Safety Plan (FSP).

Chapter 3

Animal Food Safety Hazards are described in this chapter. The hazard analysis process is described defined what to consider in this process, how to identify hazards by species and a general awareness of the biological,  chemical (including radiological) and physical hazards in animal food.

 Chapter 4

Food Safety Plan is defined in terms of required and optional elements. Example FSP’s are included in the curriculum. re described in this chapter.

Chapter 5

Hazard Analysis, and Preventative Controls Determination – in this chapter you will learn how to conduct a facility specific hazard analysis including how to the access the severity and probability of a hazard and to determine if a hazard requires a Preventive Control.

Chapter 6

Required Preventive Control Management Components – this chapter describes the steps you must take to manage the Preventive Control if you have one.

Chapter 7 – 9

Defines in great detail Process Controls, Sanitation Controls and the Supply Chain Applied Control.

Chapter 10

Recall Plans – defined with examples.

Caution:

There are many organizations offering PCQI training throughout the country and this will grow over time. If you are considering attending training, make sure it is for the Animal Food Industry and that it is certified by FSPCA. Not all training is certified.

Editorial Comment:

As of July 2017, we are starting to see opportunities to take this training virtually via your computer. I have taught a class virtually and I do not recommend it for the following reasons:

  • Distractions associated with not leaving your work environment Unless you can go to a place outside the mill this is difficult to overcome.
  • Due to the interactive nature of the labs, virtual environment makes this difficult to accomplish.
  • Ability to network with others in the industry and share concerns and ideas is diminished.

Unless you have extensive HACCP background or a third party certification at your facility I do not recommend this method of delivery.

Sanitary Transportation of Human and Animal Food

21 CFR Part 1 and 11 – Sanitary Transportation of Human and Animal Food Final Rule was released April 6, 2016.

The following paraphrases information published by the FDA on April 5, 2016 at http://www.fda.gov/Food/GuidanceRegulation/FSMA/UCM383763.htm

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect feed.

* Remember “food” includes “animal feed” and I have changed the word “food” to “feed”

Key Requirements

  • Vehicles and Transportation Equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the feed that it transports to become unsafe.
  • Transportation Operations:The measures taken during transportation to ensure feed safety, such as adequate temperature controls (if required for feed safety), protection of feed from contamination by non-feed items in the same load or previous load, and protection of feed from cross contamination. This section defines roles in the transportation operations for Shipper, Loader, Carrier and Receiver all with different responsibilities.
  • Training:Training of carrier personnel in sanitary transportation practices and documentation of the training.
  • Records:Maintenance of records of written procedures, agreements and training (required of carriers).

This applies to inbound and outbound shipments. If you arrange the freight on inbound shipments or if your company delivers feed on company vehicles there are compliance requirements.

Compliance Dates:  April, 2018

Exempt from the Rule (this is a narrow list of exemptions that could apply in the feed industry)

  • Shippers, receivers, or carriers engaged in feed transportation operations that have less than $500,000 in average annual revenue
  • Transportation activities performed by a farm
  • Transportation of human food byproducts transported for use as animal feed without further processing
  • Transportation of feed that is completely enclosed by a container except a feed that requires temperature control for safety
  • Transportation of live food animals, except molluscan shellfish

Bottom Line: If you transport Bulk Feed, you need to address this rule in your SOP’s.

 

OSHA FSMA Whistle Blower Protection

FSMA added to the list of 22 programs now afforded Whistleblower Protection by the US Department of Labor under OSHA.

AFIA wrote about this topic in a FSMA update last May, summarizing as follows:

Labor Department Issues New FSMA Rule to Protect Workers from Retaliation”

… On April 15, the Department of Labor issued a final whistleblower rule through its Occupational Safety and Health Administration. The rule implements an otherwise obscure provision of FSMA that some companies may overlook at their peril.

 

Spelling Out Steps for Processing a Complaint

Section 402 of FSMA spells out requirements aimed at ensuring workers across the supply chain–from manufacturers to retailers–are protected from retaliation by their employers for “blowing the whistle” on illegal activity. OSHA’s new rule spells out several things, including how employees should file complaints for retaliation, what steps companies and the government must take in response to a complaint and what the burden of proof is for bringing a successful action.

 

One of the most important aspects of the rule to keep in mind is that employees who file complaints under the new rule are protected if they have a “”reasonable belief,” which is defined in the new regulation as a “subjective, good faith belief and an objectively reasonable belief,”” the conduct they are complaining about violates the law.” (AFIA FSMA Update May 4, 2016)

 

An OSHA fact sheet on “Filing Whistleblower Complaints under the FDA Food Safety Modernization Act” can be found at https://www.osha.gov/Publications/OSHA3714.pdf