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

Veterinary Feed Directive (21 CFR Part 558) goes into effect 12/31/16. Are you ready?

“Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. Now, the agency is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals”.

As a feed manufacturer or a store that sells medications fed to animals that fall under this law what do you need to do?

Step 1: Identify the medications, combinations, premixes and products that require a VFD. At the 2016 CFD annual meeting Dr. Eric Reid presented a list of the most common drugs used by members that will now require a VFD:

– Apramycin

– Chlortetracycline

– Erythromycin

– Gentimycin

– Hyrgomycin B

– Lincomycin

– Neomycin

– Oleandomycin

– Oxytetracycline

– Penicillin

– Spectinomycin

– Streptomycin

– Sulfachloropyrazine

– Sulfadimethoxine

– Sulfamethazine

– Sulfaquinoxaline

– Tetracycline

– Tylosin

– Virginiamycin

This list is not all inclusive, some have trade names, some are part of a product where the other ingredient doesn’t need a VFD, but those products will still need a VFD. Be diligent in finding out which products will need a VFD. See below for more information from CFD to define these requirements…

 Step 2: Register with the FDA: There is a one-time registration requirement. To comply, send a letter to the FDA stating that your company is a distributor or animal feed products under 21 CFR part 558 Veterinary Feed Directive. Include: your company name and business address; signature and date of at least one owner. Mail the notification to:

Food and Drug Administration

Center for Veterinary Medicine

Division of Animal Feeds (HFV-220)
7519 Standish Place
Rockville, MD 20855          or faxed to: 240-453-6882

 Step 3: Define a process for obtaining and retaining VFD documents. Key components of this process should include:

  • Obtaining the VFD prior to manufacturing the feed.
  • VFD must be written and signed by a Veterinarian.
  • It can be a paper document or sent electronically.
  • It can be delivered by the Veterinarian, Customer or a Nutritionist.
  • Must contain specific information: Refer to this website for details: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455415.htm
  • Can only be used for the specified time period.
  • Must be retained for 2 years.

Step 4: Train employees: All employees who receive and process orders must be trained in this requirement.

 

More Information:

CFD Commonly Ordered Items:

Item # Description Item # Description
1100010 Aureomycin 4 g  5 lb. 1800654 Tylan 40
1100034 Aureomycin 4G  50 lb 1800411 Neo/Terra 10/10
1104042 AS 700 2g 1800006 Aureomix S 10/10
1104046 AS 700 3.5g 1800005 Aureo SP 250
1800651 Aureomycin 100 1104038 Terramycin 4 g
5575320150 Scours & Pneumonia Treatment Concentrate 50# 1104044 CTC 10 g
0232123 Scours & Pneumonia Treatment Concentrate 20# 1800648 Aureo 50
5575320239 Scours & Pneumonia Treatment Concentrate 4.34# 1800649 Aureo 90
1117530 Scours & Pneumonia Treatment 6.4 oz 1100020 Aureo 20 g
1127530 Scours & Pneumonia Treatment 6# 1800688 Sulmet 12.5% liquid
2500101  CFD 20-20 AM with OTC  (to be discontinued by MFG) 1800576 Terramycin Scour tabs
1800656 Tylan 10    

 

FSMA Compliance Dates and cGMP’s

Animal Food Rule 21 CFR 507

The sub parts of this rule that you need to comply with are based on the activities you perform in your business:

  • Manufacturing – if you are manufacturing feed or feed ingredients you must be in full compliance with FSMA. In reality, if you manufacture, you are probably also processing raw materials and you certainly package them either in bag or bulk for sale.
  • Processing – There may be some facilities who do not manufacture finished feed or feed ingredients but process raw ingredients such as drying, cracking or grinding corn or crimping oats. These activities also require full compliance with FSMA.
  • Packing – If a facility only buys bulk feed or ingredients and packages it for further distribution, this activity also requires full compliance with FSMA.
  • Holding – If a facility only buys feed or ingredients and holds it in a warehouse for further distribution, much like CFD and a retail store, this activity requires limited compliance with FSMA.

What does full compliance and limited compliance require?

 

Sub Part Title Manufacture / Process / Pack Hold BY       
A General Provisions (training) YES YES 9/17/17
B Current Good Manufacturing Practice YES YES 9/17/17
C Hazard Analysis and Risk- Based Preventive Controls YES NO 9/17/18
D Withdrawal of a Qualified Facility Exemption NA NA NA
E Supply Chain Program YES NO 9/17/18
F Records (as they apply to above) YES YES As above

Sub Part B – cGMP’s – there is eight categories of cGMP’s that are considered to be necessary to the manufacture of safe animal feed. These are the foundation from which everything is built upon. This is where you start to: “say what you do and do what you say”.

In order to gain compliance with FSMA you should consider writing standard operating procedures (SOP’s) that demonstrate or document your compliance with cGMP’s.

  1. Personnel – defines employee rules regarding hygiene and sanitation.
  2. Plant and Grounds – maintenance of your facility and pest control.
  3. Sanitation – housekeeping procedures and the handling of toxic materials required to maintain sanitary conditions.
  4. Water Supply and Plumbing – water, plumbing, sewage and trash disposal procedures.
  5. Equipment and Utensils – procedures for the cleaning and repair of equipment, calibration of equipment.
  6. Plant Operations – includes purchasing, receiving, storage, processing and manufacturing.
  7. Holding and Distribution – includes packing, storing and shipping.
  8. Holding and Distribution of human food by-products for use in animal feed – process definition from packing, storing and shipping specific to human food by-products.

 

Food Safety Modernization Act (FSMA) Introduction

The Food Safety Modernization Act (FSMA) is made of seven rules that apply to Human and/or Animal Food as follows:

Rules applicable to Animal Food Rules NOT applicable to Animal Food
Preventive Controls for Animal Food Preventive Controls for Human Food
Foreign Supplier Verification Program Produce Safety
Accredited Third-Party Certification Intentional Adulteration
Sanitary Transportation

This site focuses on Preventive Controls for Animal Food 21 CFR 507 and  Sanitary Transportation 21 CFR Part 1 and 11. 

The purpose of the Food Safety Modernization Act is to improve the safety of food fed to animals and humans.

Who must comply with the Food Safety Modernization Act?

  • The short answer to this question is all facilities required to register under the Bioterrorism Act of 2002. This begs the question:

Who must comply with the Bioterrorism Act of 2002?

  • You must register your facility if you are the owner, operator, or agent in charge of a facility, engaged in the manufacturing / processing, packing, or holding of food for consumption in the United States.

As with all regulations, look to the definition of the words for further clarity… To simplify the reading and understanding of the law I have taken out the legalese that makes the law seem more difficult than it is. As always, refer to 21 CFR 507 for the exact definition.

Define Facility: any establishment, which is under one owner, at one general physical location. A facility may consist of one or more contiguous structures, and a single building may house more than one facility if the facilities are under separate ownership.

Define one owner: individuals, partnerships, LLC, Corporations responsible for a business entity.

Define food: Food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.

For the remainder of this document I have changed “food” to “feed” as it applies to our industry.

Define manufacturing/processing: means making feed from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating feed, including feed crops or ingredients.

Define packing:  placing feed into a container (bulk, tote, bag) other than placing the feed into a container that directly contacts the feed and that the consumer receives.  Includes re-packing and activities performed incidental to packing or re-packing a feed.

Define holding: storage of feed and also includes activities performed incidental to storage of a feed (e.g., activities performed for the safe or effective storage of that feed, such as fumigating feed during storage, and drying/dehydrating raw agricultural commodities). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets). Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

Are there any exceptions from complying with the rule?

Short answer is yes. All laws have exemptions but there are also reporting requirements that go along with those exemptions. Exemption does not mean you do nothing, you must apply for exemption.  I will not describe the types of exemptions available. I recommend you seek legal guidance to determine your eligibility for exemption.

Therefore, CFD recommends that all members and customers registered under the bioterrorism act embark on the path to compliance not only because it is the law but it will have a positive impact on your business.