Creepy-Crawly War on Food Operational 2024


 This historical document is made by possible by your subscriptions and donations.  See my LinkTree in my Bio

This article was written in 2019 for my supporters.  I went on air for a 2-hour special with Steve Quayle and Doug Hagmann.

To listen to the October 14, 2019 show:

Stay tuned for Breaking News Coverage and Details on this global Food Takeover this week.

What does the UN, Chronic Wasting Disease (CWD), 9-11, Famine, Command, and Control have to do with one another? 

We are entering a time in history when our food supply will vanish due to God's judgment on mankind for his unrepentant sin, the Grand Solar Minimum, collapse of the magnetosphere flooding the earth with galactic and solar cosmic ray flux, radiation, chemicals, synthetic biology, and climate chaos.

Famine in Prophecy


Let’s step back in history to the book of Leviticus for a look at God’s warning to man through the example of Israel. Here we can see the consequences of false religion, war, famine and pestilence when Israel was unfaithful to God.

Leviticus 26 is a chapter of promises from God—the promise of blessings for obedience and of curses for disobedience. The first step toward blessings is faithfulness in the worship of the true God.

For keeping His statutes and commandments, God promises in the next verses the necessities for plentiful food production: “rain in its season” so that “the land shall yield its produce, and the trees of the field shall yield their fruit … you shall eat your bread to the full, and dwell in your land safely.”

Continuing, God says: “I will give peace in the land, and you shall lie down, and none will make you afraid; I will rid the land of evil beasts, and the sword will not go through your land … For I will look on you favorably and make you fruitful, multiply you and confirm My covenant with you” (Leviticus 26:3-9).

Biblical living promotes divine blessings of good weather, fertile soil and plentiful rainfall. Peace, material abundance, good health and the absence of disease would follow. In other words, the curses like those accompanying the horsemen of apocalyptic disaster would not go through their land as long as they sincerely obeyed God and worshipped Him in truth.

Terrifying Look into the Future


In Deuteronomy 28, God details the horror of a people stricken with the curse of famine. It demands our attention so we may understand what lies ahead for the world when the third horseman rides.

For disobedience, God says He would bring a nation from afar to besiege and blockade the cities. All the food stores would be forcibly taken. The resulting starvation would cause the social structure to unravel at a frightening speed. The results are horrifying to contemplate.

You shall eat the fruit of your own body, the flesh of your sons and your daughters … in the siege and desperate straits in which your enemy shall distress you. The sensitive and very refined man among you will be hostile toward his brother, toward the wife of his bosom, and toward the rest of his children whom he leaves behind, so that he will not give any of them the flesh of his children whom he will eat, because he has nothing left in the siege …” (Deuteronomy 28:53-55). 

Eat Babies

Ms. Ocasio-Cortez declared at a town hall event in 2019 regarding climate change, "that there are only “a few months left!” and that it is time to “start eating babies!”  This is what Israel did when under seige in the  Book of Lamentations.

We are not going to be here for much longer because of the climate crisis,” the woman said as she appeared to have an accent. “We only have a few months left!”

I love that you support the Green Deal, but it’s not getting rid of fossil fuel, it’s not going to solve the problem fast enough,” the woman continued. “A Swedish professor [said] we can eat dead people but that’s not fast enough. So I think your next campaign slogan has to be this: ‘We got to start eating babies! We don’t have enough time! There is too much CO2.”

Famine-induced cannibalism is the lowest depth of depravity to which a nation can sink. Yet scenes like this have occurred in history —and God says they will happen again. Reading this in the light of today’s reported tragedies is profoundly sobering. But such deeply distressing events inevitably occur when men and women become entrenched in their disobedience to God’s laws.

Nothing is more basic to human survival than food and water. Yet the entire world is wholly dependent on elements totally beyond human control—namely sufficient rainfall, sunshine, temperate weather and fertility of the earth beneath our feet—to keep us alive.

Devastating Famines of the Past

Famine is listed in Revelation 6 as following the previous horsemen of religious deception and war. While nature—drought, floods and insect infestations—is often the cause of famine, quite often war and misrule, as well as malignant political or religious ideology, are prime factors. A look at past famines gives us an idea of how devastating they can be.

During the 20th century two humanly engineered famines brought devastating consequences.

In 1932-34, the Soviet dictator Joseph Stalin sought to suppress Ukrainian nationalism by forcing a system of collectivized agriculture on the peasants. Food supplies were removed to the cities, crops failed and food supplies were barred from the region. This manmade famine resulted in the starvation of between 6 and 8 million people. It was a state-sponsored attempt at genocide.

China’s “Great Leap Forward” in 1958-60 resulted in mismanaged food production and the disruption of distribution chains. Fertile rice fields were plowed over and factories built on them. Farms were collectivized. Farmers who knew only the land were at a loss in factories. Coupled with bad weather, the result was the death of 20 million people by starvation during 1960 and 1961.

The United Nation Has a Plan

In 2019, the UN reduced the food supply by 20% as UN predicted. Next up will be selling food by the 1/1000th of a calorie.  Or if DARPA has their way selling food by the molecule. I am seeing trends that it will be by the molecule.

In 1996, the UN declared on its Biodiversity Convention website that it would deploy genetically modified organisms and other modifiers into wilderness and forested areas. They were declaring that they were actively and deliberately polluting the wildlife and plants around the world so that they could not be used as a food source. At the time, some of us realized that it would manifest at a time when commercial food would be unattainable. 

Contaminated Food Supply

In a Public Disclosure lawsuit, I obtained documentation from the Department of Agriculture correspondence interagency that the government knew that the commercial food supply would become so tainted that the public would lose their confidence and they could proceed with a three-prong assault on the American people which at the time was called the National Animal Identification System, now mandatory and called Traceability. This program has been active since its introduction on Halloween, Oct. 31, 2005, and yet massive food recalls persist and we are not even talking chemical and other adulterants such as blood and babies. 

The three pillars of Traceability:

  • Register all property that has potential to make $1K/yr. Property receives a unique alpha-numeric identifier with a country code. This transfers the first position of the property to the government in case of governmental default.

  • Electronic identification of all life human, animal, plant

  • 24/7 surveillance

Wild Animals-CWD

It is believed that CWD began at feed stations that contained prion infected or kuru nervous system or brain tissues thus infecting other animals.

Chronic Wasting Disease (CWD) is an infectious, degenerative disease of animals in the elk, deer, and moose, etc. that causes brain cells to die, ultimately leading to the death of the affected animal.

First recognized in Colorado in 1967, CWD was described as a clinical 'wasting' syndrome of unknown cause. It came to Montana in 1999 to a farmed wildlife refuge.

It later became clear that CWD was a member of a group of diseases known as transmissible spongiform encephalopathies or TSEs. TSEs include a number of different diseases that affect animals or humans, including bovine spongiform encephalopathy (BSE or “mad cow”) in cattle, scrapie in sheep and goats, and Creutzfeldt-Jacob disease (CJD), variant CJD, Kuru, fatal familial insomnia, and Gerstmann-Straussler-Scheinker syndrome in humans.

Unlike other infectious diseases, TSEs are not caused by bacteria or viruses, but rather by a naturally occurring protein, that when folded incorrectly, becomes both infectious and deadly. The prion protein in its normal state is thought to have a role in functions such as cell signaling and neuroprotection. It is still unclear what initially causes the normal shaped protein to misfold into the infectious form. Once misfolded, the infectious prion proteins continue to convert more and more normal prion proteins to the misfolded form. Misfolding of prion proteins in the brain leads to the death of neurons (brain cells) resulting in dysfunction in the body, ultimately causing death. The incubation period can be long (several months to years) depending on species and genetic factors, and infected animals are in good body condition until the end stages of the disease, making them difficult to distinguish from healthy animals.

Unfortunately, animals infected with CWD can
transmit the disease to other animals during the “silent” incubation period.

Scientific Highlights:

Artificial Prion Proteins

Researchers have injected synthetic, artificially generated misfolded prions into mice and caused TSEs that were transmissible to other mice, demonstrating that the protein itself, and not other pathogens, was responsible for the transmission.

Non-traditional immune response

The body recognizes viral and bacterial pathogens as invaders and activates the immune system in response to their presence.  There are two types of immune responses; the innate immune response which is characterized by fever and inflammation, and the adaptive immune response which is essentially the accumulated “memory” of previous exposures to a pathogen. The latter response generates antibodies to quickly recognize and fight viral and bacterial invaders. TSEs do not trigger the activation of either type of these immune responses. There is neither fever, nor antibodies generated in TSE infections. Considering that the prion protein is a normal cellular protein and the only difference between the normal and misfolded form is the shape, the body does not recognize it as a pathogen. This lack of recognition is responsible for the lack of classical immune responses.

Resistance to Inactivation

TSEs are unusually resistant to inactivation. Standard bacterial and viral inactivation methods such as autoclaving, burning, radiation, and chemical treatments are ineffective against TSEs [18-20]. Most striking are their resistance to heat and radiation. In an incineration study, complete inactivation was not achieved until the material was burned at 1000֯ C (~1800֯ F) [18]. TSEs are generally impervious to gamma radiation, while bacteria and viruses are not. TSEs remained infectious after exposure to 200kGy of gamma radiation. In comparison, chicken viscera can be sterilized with 20kGy of gamma radiation.

Environmental persistence

Due to their resistance to inactivation, TSEs are also extremely persistent in the environment. A farm that housed scrapie-infected sheep was found to still be contaminated with the disease 16 years after infected animals were removed.

In the final stages of disease, animals become thin, drink and urinate excessively, have poor balance and coordination, lack body fat, have drooping ears, and difficulty swallowing (which is responsible for the classic drooling associated with the disease). Inability to swallow leads to aspiration pneumonia and death. Currently there is no cure or preventative measure, such as a vaccine, available for CWD. Other disease may present in a similar manner so post mortem testing is required to verify disease.


Scientists believe CWD proteins (prions) likely spread between animals through body fluids like feces, saliva, blood, or urine, either through direct contact or indirectly through environmental contamination of soil, food or water. Once introduced into an area or farm, the CWD protein is contagious within deer and elk populations and can spread quickly. Experts believe CWD prions can remain in the environment for a long time, so other animals can contract CWD from the environment even after an infected deer or elk has died.

On July 10, 2017, the scientists presented a summary of the study’s progress in which they showed that CWD was transmitted to monkeys that were fed infected meat (muscle tissue) or brain tissue from CWD-infected deer and elk. Some of the meat came from asymptomatic deer that had CWD (i.e., deer that appeared healthy and had not begun to show signs of the illness yet). Meat from these asymptomatic deer was also able to infect the monkeys with CWD. CWD was also able to spread to macaques that had the infectious material placed directly into their brains.

This study showed different results than a previous study published in the Journal of VirologyExternal in 2018, which had not shown successful transmission of CWD to macaques. The reasons for the different experimental results are unknown. To date, there is no strong evidence for the occurrence of CWD in people, and it is not known if people can get infected with CWD prions. Nevertheless, these experimental studies raise the concern that CWD may pose a risk to people and suggest that it is important to prevent human exposures to CWD.

Chronic wasting disease (CWD) is an established wildlife issue that has been detected in at least 26 states, three Canadian provinces, South Korea, Finland, Norway, and Sweden.

Command and Control of the Food Supply

On October 1, 2019, the new FDA: New Food Safety Dashboard to Track FSMA Progress was launched.

To enhance compliance with the Food Safety and Modernization Act (FSMA), the Food and Drug Administration (FDA) launched a new dashboard that will track and monitor how companies are implementing parts of the law, and how those changes are affecting the food safety system.  It is designed on the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter Food Safety, code of synthetic food continuing the successful implementation of FSMA will support the Agency’s goal of food control.

This set of measures focuses on the FSMA rules entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (PC Human Food Rule) and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC Animal Food Rule).

The first compliance dates for these rules arrived in September 2016 for the largest businesses.

I. Adoption of Food Safety Plans by firms subject to the Preventive Controls requirements of the Current Good Manufacturing Practice and Preventive Controls rule for Human Foods

II. Preventive Controls Human Food Supply-Chain Program Requirements

III. Number and Percent of Domestic Preventive Controls inspections classified NAI, VAI, OAI

IV. Number and Percent of Animal Food CGMP inspections under 21 CFR part 507 classified NAI, VAI, OAI

 I. Number of Class I and Class II recall events attributed to food produced at facilities subject to the Preventive Controls requirements of the CGMP & PC Human Food rule

II. Number of Class I and Class II recall events attributed to food produced at facilities subject to the Preventive Controls Animal Food rule

III. Time between recall initiation and firm issuance of initial press release to the public for Class I recalls


9-11 and Bioterrorism Act of 2002


The definition of a facility goes back to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).  In the Bioterrorism Act, Congress required any “facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States” to register with FDA.  When FDA wrote the regulations for registration of food facilities, it defined a facility as any establishment that manufactures, processes, packs, or holds food for consumption in the U.S.

The Bioterrorism Act

The events of September 11, 2001 highlighted the need to enhance the overall security of the U.S. food supply. As part of the nation's response, Congress passed and the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act/BTA).

The Act includes a number of provisions designed to improve the food safety efforts of the Food and Drug Administration (FDA)

The Bioterrorism Act specified that farms were excluded from coverage, but provided this confusion definition of farms: “facilities in one general location devoted to the growing and harvesting of crops and/or raising animals,” and which extend only to certain types of manufacturing, processing, packing, and holding activities.

So although the Bioterrorism Act technically excluded farms, restaurants, and other retail food establishments (like grocery stores) from the definition of “facility,” in practice, the definition meant that some farms had to register as facilities and others did not.  Under the Bioterrorism Act, some farms triggered the definition of facility because they conducted certain manufacturing, processing, packing, or holding activities.  The types of activities that triggered the facility definition were many of the light processing activities that farms do to their products.

When Congress wrote the Food Safety Modernization Act (FSMA), it did not change the definition of “facility,” but it did clarify that farmers’ markets, community-supported agriculture (CSA) programs, and other direct-to-consumer sales platforms came under the definition of a retail food establishment and, therefore, were not facilities and did not have to register with FDA.  However, FDA has not clarified this important distinction in the rules, which may force these kinds of operations to come under increased regulation (see below).


Became Public Law No: 107-188. (TXT | PDF)


Signed by President.


Presented to President.


Conference report agreed to in Senate: Senate agreed to conference report by Yea-Nay Vote. 98 - 0. Record Vote Number: 124.


Conference report agreed to in House: On agreeing to the conference report Agreed to by the Yeas and Nays: 425 - 1 (Roll no. 189).


Conference report filed: Conference report H. Rept. 107-481 filed.(text of conference report: CR H2691-2732)


Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.


Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 418 - 2 (Roll no. 493).(text: CR 12/11/2001 H9195-9209)


Introduced in House


Bioterrorism Act of 2002 came from working groups consolidating and streamlining the functions of two existing working groups first established under the “Public Health Threats and Emergencies Act of 2000.”

Public Health Threats and Emergencies Act of 2000” by authorizing additional measures to improve our health system's capacity to respond to bioterrorism, protect the nation's food supply, speed the development and production of vaccines and other countermeasures, enhance coordination of federal activities on bioterrorism, and increase our investment in fighting bioterrorism at the local, state, and national levels.

FDA Overview of the Seven FSMA Rules

(Seven indicates a biblical judgment by God)

FSMA is broken into 7 different rules, with the intent to protect the U.S. food supply during all points of the supply and distribution chains. Each rule covers a specific part of domestic food production, processing and transportation of human and animal food, as well as the importation of food for humans and animals, and strategies to mitigate intentional adulteration. All of those pesky Presidential Orders were being codified into the law of the land.

The FSMA Rules are a science-and risk-based approach to the management of food safety.

Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), which covers fruits, vegetables and tree nuts that are likely to be consumed raw.

This is the first time the produce industry has been regulated at the farm level. The USDA Good Agricultural Practices (GAPs) are voluntary recommendations, and offers a certification upon request. Certification is driven by market demand.

Focuses on activities associated with the five identified routes of contamination: agricultural water, domestic and wild animals, sanitation of building, tools, and equipment, soil amendments of animal origin, and worker health and hygiene.

Accredited Third-Party Certification, addressing the requirements for accreditation and certification of third-party auditors.

Provides the accreditation framework, procedures and requirements that third-party auditors must meet to receive certification.

Importers can use certifications to 1) expedite the review of entering the country or 2) have a food certified by an accredited third-party auditor when the FDA determines circumstances are warranted.

FSMA Rules for Processed Foods

Below is an overview of the FSMA rules for processed foods, and summarizes the requirements for food entering the U.S. supply and distribution chains. For full requirements, please see the appropriate FSMA rule.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventative Controls for Human Food).

All domestic food production facilities must comply with the modernized Current Good Manufacturing Practices.

Food production facilities that must register with the FDA are also governed by the Preventative Controls for Human Food rule.

A written HARPC food safety plan must be developed, implemented, monitored, and verified.  A recall plan is a required component of every facility having a preventative control.

Where an identified hazard will be controlled in a facility’s supply chain (through further processing by the facility's customer) the facility is required to have a supply chain program. Specific documentation is required.

Two definitions of Farm are specified – Primary Production Farm, and Secondary Activities Farm.  Farms meeting either of these definitions are not governed by the Preventative Controls for Human Food rule.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventative Controls for Animal Food)

Very similar to the Preventative Controls for Human Food, this rule ensures the safety of food used for livestock as well as pets.

Covers human food by-products (whether sold or donated) that will be used as animal food. Facilities must comply with the Current Good Manufacturing Practices except as noted below.

Heated by-products for animal food must comply with Current Good Manufacturing Practice for either human food or animal food.

If by-products were made under the Preventative Controls for Human Food, no further preventative controls need to be implemented.

If by-products are being held only, then no additional Current Good Manufacturing Practices need to be implemented except to prevent contamination.

A written HARPC food safety plan must be developed, implemented, monitored, and verified.  A recall plan is a required component of every facility having a preventative control.

Two definitions of Farm are specified – Primary Production Farm, and Secondary Activities Farm. Farms meeting either of these definitions are not governed by the Preventative Controls for Animal Food rule.

Sanitary Transportation of Human and Animal Food (Sanitary Transportation)

Applies to human and animal food transported by rail or motor vehicle into the U.S. and entering the food supply and distribution chains. Food transported across U.S. borders by rail or motor vehicle, and not entering the U.S. food supply, is not covered by this rule.  

Export companies transporting food out of the country are covered until the shipment reaches a port or the U.S. border.

Loaders, motor vehicle or rail shippers, carriers and receivers are covered by this rule. Waivers are provided for 1) certified National Conference on Interstate Milk Shipment for certain Grade A milk and milk products, and 2) food establishments such as grocery stores, restaurants and home grocery delivery operations holding valid local jurisdictional permits and delivering food from their establishment to the customer.  

Provides sanitary requirements for vehicle and transportation equipment, transportation operations, training, documentation and recordkeeping.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier)

Assures foreign food suppliers are providing human and animal food meeting FSMA level compliance at the time of importation.

Covered importers are U.S. owners or consignee, or U.S. agency or foreign owner or consignee representative at the time of entry.  

Importers are responsible for verifying foreign food suppliers are compliant with the appropriate FSMA rule, and taking corrective action if necessary.

A written HACCP plan and mitigation plan are required of all foreign food suppliers.  

Importers are considered to be in compliance with the major elements of the Foreign Supplier rule if they are also processors or manufacturers and are in compliance with the applicable FSMA rule governing that food.

The Foreign Supplier rule specifies:

1) criteria which supplier verification activity must be conducted: annual onsite audits, sampling and testing and records review,

2) corrective action procedures, and

3) exemptions and modifications to the rule.  

Importers are allowed to rely on third-party verification entities for verification of Foreign Suppler activities.

Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)

Protecting the U.S. food supply from economically motivated adulteration.

Targets processes in large domestic and foreign FDA registered food facilities.

Requires covered companies to develop a written Food Defense plan, identify and assess the vulnerabilities of each type of food processed, manufactured, packed or held at the facility. For each vulnerability identified, mitigation strategies must be developed to minimize or prevent the vulnerability, and management and monitoring procedures to verify effectiveness.

Many companies covered by the Food Defense rule, will also be governed by other FSMA rules.  With this in mind, FDA has extended the timeline for companies to comply with the Food Defense rule.

Three Types of Food Safety Plans 

Through this discussion of the seven FSMA rules for processed foods, you may have noticed the mention of several food safety systems. All are based on prevention, but they each have a different focus.  Below is a very brief overview:

HARPC (Hazard Analysis and Risk-Based Preventative Controls)

FDA mandated through FSMA, this food safety plan has a broader scope than HACCP, in that is looks at all risk points, known or reasonably foreseeable hazards, with the intent of proactively taking steps to significantly minimize or prevent the hazard. Chemical, biological and physical hazards, as well as naturally occurring, intentionally and unintentionally introduced hazards are all part of HARPC.

HACCP (Hazard Analysis and Critical Control Points)

A globally recognized, voluntary, food safety standard primarily driven by retailers, auditors, and inspectors. An exception is where the FDA or USDA requires a HACCP plan for meat, seafood and juice production. HACCP looks at critical points in the food process system and applies controls to prevent, eliminate or reduce the hazard to a safe level.

Minimum temperature and time requirements when cooking meat, is one example.

Food Defense Plan

An FDA mandated food safety system that is vulnerability based.  Developing a Food Defense Plan is similar to developing a HACCP plan. Each step in the production of a food is evaluated for several criteria and actionable steps put in place to mitigate the vulnerability.

This is a new type of food safety plan, introduced with the Food Defense rule.

FSMA Rule Compliance Dates 

Compliance dates for each rule are dependent on the published date of the finalized rule and the size of the covered company. For a comprehensive list of compliance dates for all rules, click here. To learn more about the FSMA Rules, click here.

See how EHS Insight can help you document your FSMA compliance.

Who is Affected? 

If you operate a business that grows and sells fresh produce – and/or processes, packs, manufactures, or holds food – you should read the following information, as your business may be affected by the proposed FSMA rules. Some businesses may not be affected at all, some may be affected by one rule, and some may be affected by both rules.

To learn about the FSMA, read NSAC’s FSMA Overview and Background.

The information included below is intended to help individuals gain a better understanding of whether or not their business operation may be impacted by the proposed rules. Farmers and business owners nationwide are reporting confusion in determining if they might be impacted by these rules. If you are uncertain, you are not alone! These rules are complex and confusing for producers.

For Producers and Processors, Start Here:

Do you grow, harvest, pack, or hold (store) fruits or vegetables? If yes, you may be affected by the Produce Rule.

Do you process, manufacture, pack, or hold (store) human food? If yes, you may be affected by the Preventive Controls Rule.

Do you BOTH grow, harvest, pack, or hold (store) fruits or vegetables AND process, manufacture, pack, or hold (store) human food? If yes, you may be affected by BOTH the Produce Rule and the Preventive Controls Rule.

Are you a food hub, CSA farm, on-farm processor, or direct marketer? We also have special guidance available for these operations. 

Download our “Am I Affected?” flowchart to help determine if your business may be subject to the proposed Produce or Preventive Controls Rules!

Scroll down for detailed text to help you determine whether you may be affected by the Produce Rule or Preventive Controls Rule.

For Consumers

If you’re a consumer, these rules could, over the long term, impact the kind of food you are able to find and purchase in your community.  The proposed rules may also increase the costs of purchasing fresh fruits and vegetables. Ultimately, we want to ensure a safe and affordable food supply, strong on-farm conservation of natural resources, and thriving family farms and small value-added farm and food businesses. That translates into fresh, healthy food for communities across the country, from the farmers’ market to the grocery store to the school cafeteria!

Please note: these rules DO NOT affect home gardeners who grow food for personal consumption.

Produce Rule – Are You Affected?

If you grow, harvest, pack, or hold produce, you may be subject to part or all of the Produce Rule.

Farms are likely to fall into one of four categories:

1) exempt from the Produce Rule,

2) subject to less extensive modified requirements under the Produce Rule,

3) subject to full requirements of the Produce Rule but with extended time to come into compliance, or

4) subject to full requirements of the Produce Rule without extended compliance time.

 Exemptions from the Produce Rule

You may be fully exempt from the Produce Rule (also referred to as eligible for the ‘de minimis exemption’) if you sell under a certain amount of fresh produce or if you do not grow anything that is covered by the proposed rules:

Produce that is NOT covered by the Produce Rule includes:

Produce grown for personal or on-farm consumption (except if you give it to a guest or even your own family)

Produce that is rarely consumed raw (e.g, potatoes, turnips, winter squash)

Produce that is not in its raw or natural state (i.e., produce that receives additional processing and that would be subject to the Preventive Controls rule)

Review FDA’s list of covered produce to determine if the products you grow are covered or not. Keep in mind that this list may change.

(b) For the purpose of this part and subject to the exemptions and qualified exemptions therein, covered produce includes all of the following:

(1) Fruits and vegetables

(2) Mixes of intact fruits and vegetables (such as fruit baskets).

Subject to Modified Requirements

If you are not eligible for a full exemption from the rules, you may be eligible for less extensive and less costly modified requirements under the Produce Rule (also referred to as “qualified exempt”). There are two main ways by which a produce operation may be eligible for these modified requirements:

If the produce you grow will undergo additional commercial processing that kills harmful microorganisms, then the produce is not covered, but you are still subject to the recordkeeping requirements and the compliance and enforcement requirements of the Produce Rule.

If your farm on average over the previous 3 years has less than $500,000 in gross annual sales (not just produce or covered produce, but ALL food) AND the majority of the food you sell is sold directly to a “qualified end-user,”* then you must:

Provide the name and complete address of the farm where the produce was grown on either a food packaging label or on a sign at the point of purchase;

Comply with the compliance and enforcement requirements of the Produce Rule; and

Be subject to the provisions regarding the withdrawal of your status as a partially covered (“qualified exempt”) operation (That is, FDA reserves the ability to revoke your “qualified exempt” status in certain circumstances).

*A “qualified end-user” is a consumer, or a restaurant or retail food establishment that is located in the same state as the farm that produced the food, or not more than 275 miles from that farm.

Completely Subject to the Produce Rule with Extended Compliance Time

You are completely subject to the requirements of the Produce Rule if you grow, harvest, pack, or hold produce that is usually consumed raw and you do not fall under the categories for exemptions or modified requirements. However, producers who do not fit the modified requirement guidelines above but who do meet other criteria are eligible for additional time to bring their businesses into compliance as follows:

Everyone had 3-5 years to comply depending upon the dollar amount of your sales

 Completely Subject to the Produce Rule without Extended

Compliance Time

You are completely subject to the requirements of the Produce Rule if you grow, harvest, pack, or hold produce that is usually consumed raw and you do not fall under the categories for exemptions or modified requirements.

Preventive Controls Rule – Are You Affected?

Farms and food businesses are likely to fall into one of five categories:

1) exempt from food facility registration, and therefore not covered by the Preventive Controls Rule,

2) have to register as facilities, but exempt from the full requirements of the Preventive Controls Rule,

3) have to register as facilities, but subject to less extensive modified requirements under the Preventive Controls Rule,

4) subject to full requirements of the Preventive Controls Rule, but with extended time to come into compliance, or

5) subject to full requirements of the Produce Rule without extended compliance time.


At the heart of trying to understand whether farms will be subject to the Preventive Controls rule is the definition of a “facility.” At this point there is still a lot of confusion about the activities conducted by a farm that might trigger the FDA’s definition of a facility. This is a large gray area.

Do You Operate a Facility?

You operate a facility if you manufacture, process, pack, or hold food for consumption in the U.S. Many activities fall under the definitions of manufacturing and processing, and the key distinction for FDA seems to be whether you are transforming a product in any way.

Manufacturing and processing activities always include:

  • Irradiation

  • Cutting/coring/chopping/slicing

  • Except field coring (e.g. removing the core of lettuce in the field), which is considered harvesting.

  • Canning

  • Coating with things other than wax/oil/resin

  • Drying/dehydrating to create a distinct commodity

  • Except if you dry/dehydrate without doing any additional processing (e.g. drying herbs, or drying grapes to make raisins), then that activity falls is considered a “farm” activity and not a facility activity.

  • Artificial ripening

  • Cooking

  • Pasteurizing/homogenizing

  • Infusing

  • Distilling

  • Salting

  • Smoking

  • Grinding/milling

  • Freezing

  • Slaughtering animals or post-slaughter operations

Information about Coverage for Facilities

The Preventive Controls rule has two main parts that originate from the UN:

New requirements for hazard analysis and risk-based preventive controls (HARPC); and

Revisions to existing Current Good Manufacturing Practice (GMP) requirements.

Coverage under these two parts must be considered separately because certain facilities are subject to one and not the other.

Are You Covered by the New Requirements for Hazard Analysis and Risk-Based Preventive Controls (HARPC)?

1. Not Covered by the Preventive Controls Rule

If you are a farm or a retail food establishment, then you are exempt from the requirement to register as a food facility, and therefore are not a facility subject to the Preventive Controls rule.

However, as described above and in more detail on our Do I Operate a Farm or a Facility page, some farms may also be considered facilities, and would therefore have to register with FDA and be subject to the Preventive Controls Rule.

Visit our page on direct marketing under the Preventive Controls Rule for more information on the retail food establishment exemption.

2. Facilities EXEMPT from the New HARPC Requirements:

Facilities that manufacture products covered by separate regulations:

  • Juice
  • Seafood
  • Dietary supplements
  • Alcoholic beverages
  • Low-acid canned foods (only with respect to microbiological hazards)

Facilities such as grain elevators and warehouses that are solely engaged in storing agricultural commodities (other than fruits and vegetables) intended for further processing

Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment and for which refrigeration is not required for safety

Facilities that are small or very small on-farm businesses that conduct certain low-risk manufacturing and processing, packing, or holding activities (e.g., making jams and jellies and manufacturing honey and maple syrup; for a list of those proposed low-risk activities, click here)

Farms are not covered by the new requirements, unless they trigger the “facility” definition (see above)

*A “qualified end-user” is a consumer, or a restaurant or retail food establishment that is located in the same state as the farm that produced the food, or not more than 275 miles from that farm.

Very small businesses also have three years to come into compliance with the rule.

Must You Comply with Current Good Manufacturing Practices?

If you operate a facility, you almost certainly must already comply with current Good Manufacturing Practices (GMPs). The only facilities that FDA exempts from current GMPs are facilities such as warehouses and grain elevators that store raw agricultural commodities (including fruits and vegetables) intended for further distribution or processing.

Hang in there!

There is still a lot of confusion about what activities trigger the definition of a facility and the requirements for different facilities. Satan is the author of confusion.

Chronic Wasting Disease Resource Center

CWD Response, Research, and Policy Program

The Chronic Wasting Disease (CWD) Response, Research, and Policy Program addresses the transmission of CWD in cervids and its potential for spread to humans and other animal species. The program supports current and reliable information on CWD for the public, including hunters; the medical, veterinary and public health communities; wildlife scientists and managers; and public policymakers.

About CIDRAP's CWD Program                          About CWD

Expert Advisory Group

The program includes 46 national and international world-renowned and distinguished leaders in public health, medicine, science, wildlife, and agriculture. |

Oct 07, 2019 "Seeing a deer test positive for CWD west of the continental divide again is concerning."

AFWA's Best Practices to Prevent CWD

Association of Fish & Wildlife Agency (AFWA) recently published a comprehensive document identifying the best practices for CWD prevention, surveillance, & management.

CWD mBio paper

A CIDRAP-led team published an article in mBio on CWD in cervids and implications for prion transmission to other animals & humans (Osterholm et al).


About CIDRAP's CWD Program

The Chronic Wasting Disease (CWD) Response, Research, and Policy Program addresses the ongoing transmission of CWD in cervids and its potential for spread to humans and other animal species. The program supports current, comprehensive, and authoritative information on CWD for the public, particularly hunters; the medical, veterinary and public health communities; wildlife scientists and managers; and public policymakers and elected officials. Guided by members of its Expert Advisory Group, which includes distinguished national and international experts and experienced professionals representing hunter groups, prion biology, diagnostics and epidemiology, wildlife management and health and human health, the CWD Response, Research, and Policy Program is focused on:

providing coordinated and proactive national leadership with government agencies and others that identifies and defines priority policy, prevention, research and community outreach issues associated with CWD in animals and its potential for animal-to-human and human-to-human transmission; educating the public, particularly hunters, the medical and public health communities, wildlife scientists and managers, public policymakers and elected officials about the potential risk of human CWD infection; promoting extensive, reliable and rapid CWD prion detection tests for killed cervids before the deer are processed or consumed;conducting primary prevention research on limiting the potential transmission of the CWD prion to humans and between animal species.


Fortunately, various conservation and wildlife organizations understand the challenges that CWD presents and have taken efforts to educate people about CWD and ultimately help control this disease. Learn more about some of these organizations that are involved in the fight against CWD.

Cervids: Chronic Wasting Disease Specifics

Last Modified: Feb 28, 2019

Exposure and Transmission

Cervids are exposed to chronic wasting disease (CWD) orally and/or intranasally by direct animal to animal contact, and/or indirectly by contact with infected items in the environment, such as soil, dust, or forage. Animals are able to shed infectious prions into the environment in feces, urine, and saliva during the incubation period. While the concentration of infectious prions are low in these excreta, accumulation in the environment can be significant, as infectious prions do not readily degrade in the environment. This environmental persistence can lead to robust levels of infectivity in areas where the disease is prevalent.

 Recent research has suggested that plants can take infectious prions up into stems and leaves through the roots, however, this work was done in laboratory settings and it is unclear what happens under real-world conditions. More research needs to be done on this subject to better under-stand plant uptake and its significance in disease transmission.


CWD enters the body either orally and/or intranasally and typically ends up in the lymph nodes of the head. Once inside the lymph nodes, the infectious prions proliferate, converting normal prion proteins to the misfolded form. From the head lymph nodes, the infectious prions make their way to the rest of body, including the lymphoid tis- sue around the rectum, and lastly the brain.

No CWD-resistant genotype has been discovered. The distribution of these genotypes is significantly different between wild and farmed populations.


There are two approved tissue types for official CWD post mortem testing in cervids, the medial retropharyngeal lymph nodes (MRPLNs), and brainstem, also known as the obex.

 Two diagnostic tests are currently approved for official CWD post mortem testing in cervids; immunohistochemistry (IHC) and ELISA.

Chronic Wasting Disease (CWD) and the Infectious Prion Protein

Montana CWD Management:

Introduction & Background


Response to a Detection

Public Information Plan


Montana Fish, Wildlife and Parks CWD Action Team

April 19, 2018

Actions related to the initial and long-term management of CWD have been revised, and will be initiated in a localized area around any first or new detection of CWD in free-ranging Montana deer, elk, moose or caribou (cervids). Plans for communication and outreach aim to support FWP’s goals of prevention and CWD management, and include ongoing efforts and a detailed communication plan to be implemented following any new detection of CWD in Montana’s wild herds.

This plan, especially concerning surveillance for CWD and FWP’s response to a detection, focuses on mule deer for several reasons:

1. Where mule deer, white-tailed deer, elk and moose overlap, mule deer tend to exhibit the highest prevalence of the four species.

2. Even if CWD is first detected in white-tailed deer, elk or moose, it is extremely likely that mule deer in the area are also infected, and likely at a higher prevalence.

3. Mule deer are well distributed across the state and serve as good sentinels for CWD detection.

This CWD management plan is adaptive; it is a living document that can be changed as needed.


Several sections of the Montana Code Annotated (MCA) grant FWP and the Fish and Wildlife Commission (Commission) the responsibility for the management of all wild, native cervids, including the following:

MCA § 87-1-201(1) grants FWP the authority to “supervise all the wildlife, fish, game, game and nongame birds, waterfowl, and the game and fur-bearing animals of the state….”

MCA § 87-1-301(1)(a) grants the Commission the authority to “shall set the policies for the protection, preservation, management, and propagation of the wildlife, fish, game, furbearers, waterfowl, nongame species, and endangered species of the state and for the fulfillment of all other responsibilities of the department related to fish and wildlife as provided by law….” Additionally, § 87-1-301(1)(b) provides that the Commission “shall establish the hunting, fishing, and trapping rules of the department.”

MCA § 87-1-304 further grants the Commission the authority to “fix seasons, bag limits, possession limits, and season limits” and to “open or close or shorten or lengthen seasons on any species of game….”


CWD is most easily and commonly transmitted by animal-to-animal contact but can also be transmitted by contact with a prion-contaminated environment, such as grass and soil. Infected animals shed prions in saliva, feces, and urine for most of the course of their infection, and via bodily tissues and fluids upon death. These prions may remain infectious in the environment for at least 2 years (Miller et al. 2004). CWD has an average incubation period from infection to clinical signs of approximately 16 months, and the clinical phase may last an additional 4-9 months, culminating in death (Williams and Miller 2002, Williams et al. 2002, Tamguney et al. 2009). There are no documented recoveries from infection.

In October 2017, CWD was detected in free-ranging deer in Montana. It was previously only detected in 1999 at a captive game farm outside of Phillipsburg, which was subsequently depopulated.

Documented CWD-related, herd-level declines in mule deer include a 21% annual decline in Wyoming and a 45% decline in Colorado (from 1987-2007 given prevalence of up to 41% in males and 20% in females. Among white-tailed deer in Wyoming, found a 10% annual decline in population size where prevalence was 33%, and a corresponding decline in buck age structure.

Existing management tools and evidence for their efficacy

Once CWD is present in a wild population, it is extremely difficult, if not impossible, to eliminate. New York may be the only state to have eliminated a CWD outbreak after its detection.

There are currently no effective treatments or vaccines for CWD. Prevention is critical to the control of CWD over large landscapes. Preventative tools include restricting the transport of carcasses from CWD-infected areas or states, banning the transport or translocation of wild cervids, and requiring the responsible disposal (e.g. incineration or disposal in certified landfills) of carcasses from infected regions. Many states also restrict the baiting and feeding of wild cervids to help limit artificial aggregations that might facilitate more rapid disease transmission.

Despite the low likelihood of eliminating CWD from a wild population, there are several promising tools for slowing or controlling its spread and prevalence. To date, many states have attempted a combination of population density reduction, disease “hot-spot” culling and reducing large aggregations of cervids.

In Montana and other states there has been little public support for large-scale population reductions. “Hot-spot” culling, the strategic removal of animals from a local area, uses public hunting and/or agency staff to dramatically reduce cervids in a restricted portion of a population or geographic region centered around known CWD infections.

Reducing large aggregations of cervids (i.e. large compact herds) either by eliminating food attractants (e.g. fencing haystacks), changing habitat structure, or through hunting pressure may also help reduce contact rates and transmission.

Computer simulation models have been used to explore additional options for controlling CWD. Most recently, several studies have predicted that increasing male harvest and reducing male to female sex ratios in cervids may be one of the most effective tools for reducing CWD prevalence. In most study systems, male deer are 2-3 times more likely to be infected than, presumably due to behavioral differences, and thus targeting males may be an efficient way to reduce overall transmission.

Take particular note of this solution: Natural predation, particularly by selective predators, has been predicted to help stabilize or reduce CWD prevalence, and that “the role of predators should be considered in devising strategies for control of emerging or reemerging pathogens in natural populations.

Limited empirical and modeling work to date suggests predators are good at preferentially selecting CWD-infected prey, including selecting infected animals before symptoms can be noticed by humans.

It found that mountain lions were more likely to kill infected deer than non-infected ones, and found that infected deer were four times more likely to die from cougar predation than were uninfected individuals. However, found no evidence this controlled the spread of CWD in the heavily-infected population they studied (41% prevalence among males and 20% among females); prevalence remained high despite high predation rates. They speculated (p.2) that, “the tendency for predation to promote social grouping among herbivores could help sustain transmission by maintaining relatively high effective densities even as overall deer abundance declines, and concluded (p. 2), “our data show that prion infection in a natural population can surge seemingly unabated even in the face of intense selective predation.”

Wild suggests that coursing predators like wolves would be even more efficient at selectively removing infected individuals, and that this could substantially limit CWD prevalence and spread. However, questions remain about how wolves may alter the group size, distribution, and behavior of their prey and how this may affect disease transmission rates, or how dynamics are likely to play out in systems where the disease is most prevalent in deer but where wolves prey more intensively on elk. Wolves also reduce coyote numbers which are themselves efficient predators of deer, especially fawns. Therefore, any benefit of CWD reduction due to increased wolf predation may be mitigated by reduced coyote numbers. We currently lack definitive proof that predators can control CWD, but there is reason to believe they could help.

The larger question with any plan to enhance predator numbers to address CWD is that of social acceptance. Currently, it’s not clear what the gain might be relative to the additional social costs of conflict with sportsmen, livestock producers and others. Predator management, particularly wolves, is controversial, and FWP’s current wolf management has successfully met wolf management objectives outlined in the 2002 wolf management plan (Montana Wolf Management Advisory Council 2002), and integrated wolves into a 21st century landscape with a minimum of social conflict. There may, however, be opportunity to promote increased predator densities in areas where social tolerance would allow it. 

CWD and Human Health

To date, several lines of evidence suggest that humans are at low risk of contracting CWD. There have been no documented cases of CWD causing disease in humans, despite epidemiological investigations of known or suspected exposures Several studies have demonstrated that normal prion proteins in humans, either in cell-free culture or as expressed in transgenic, do not readily convert to the diseased form when challenged with CWD prions.

Recent preliminary, non-peer reviewed Canadian study suggests that macaques can be infected by oral administration of CWD-infected meat.

Scientists and human health officials agree that it is prudent to minimize human exposure to CWD. The Centers for Disease Control (CDC) and the World Health Organization (WHO) advise against consuming any animal known to be infected with CWD. Furthermore, the CDC recommends that hunters strongly consider having their animals tested before eating the meat when hunting in areas where CWD is known to be present.

Some simple precautions should be taken when field dressing deer, particularly in CWD surveillance/endemic areas:

Wear rubber gloves and eye protection when field dressing game animals.

Minimize the handling of brain and spinal tissues.

Wash hands thoroughly after field dressing is completed.

Wash instruments thoroughly after field dressing is completed. Concentrated (40% solution) household bleach, or hypochlorous acid (may be useful in decontaminating instruments if immersed for up to five minutes.

Avoid consuming brain, spinal cord, eyes, spleen, tonsils and lymph nodes of harvested animals.


The following statutes and policies help prevent the introduction and spread of CWD into Montana:

Baiting and Feeding

Feeding of big game animals facilitates the transmission of disease by concentrating and aggregating animals. Baiting and feeding of big game animals is illegal in Montana under MCA § 87-6-216(1)(c), which states, “a person may not provide supplemental food attractants to game animals by purposely or knowingly providing supplemental feed attractants in a manner that results in an artificial concentration of game animals that may potentially contribute to the transmission of a disease or that constitutes a threat to public safety.”

Scents and Lures

MCA § 87-6-221 prohibits the use or sale of deer or elk urine to mask human odor if the urine originated in a state or province with documented occurrences of CWD. The FWP Commission has authorized exceptions to this prohibition if individual facilities meet Archery Trade Association certification of being CWD free.

Carcass Transport

CWD prions in animal excreta or carcasses have been shown to remain infectious for at least two years in the environment (Miller et al. 2004). Due to the concern over indirect, environmental transmission, 41 states (including Montana) and seven Canadian provinces have restricted the import of hunter-harvested cervid parts ( To prevent the spread of Chronic Wasting Disease from areas in Montana known to be infected to other parts of Montana, certain parts of animals harvested in those areas are not allowed outside of established

Transportation Restriction Zones. Montana law (MCA § 87-6-420) prohibits the import of heads and spinal columns of cervids harvested in states or provinces that have CWD in wild or captive populations. A list of those states and provinces is posted on FWP’s website and in the big game regulations and kept current by agency personnel. Importing processed meat, quarters, hides, antlers and/or clean skull caps, ivories, de-boned meat, finished mounts, and finished European mounts without any attached flesh are allowed. That said many processors are no longer accepting wild meats.


As of 2005, FWP no longer rehabilitates orphaned elk calves and deer fawns (Montana Fish, Wildlife, and Parks 2008). This policy eliminates the potential spread of CWD that could occur by mixing CWD infected and non-infected orphaned animals at the rehabilitation facility and later releasing those animals in the wild.

FWP has not moved wild cervids within the state since 1997

Intra- and interstate movement of game farm animals is regulated by the Department of Livestock. Movement of captive cervids from other states or within Montana requires assurance that the herd of origin has been under an active CWD surveillance plan for 5 years with no incidence of CWD. 

Carcass Disposal

Environmental contamination through dispersal of heads and spinal columns from butcher waste has the potential to introduce or spread CWD in wild populations. The U.S. Environmental Protection Agency (EPA), the State of Wisconsin, and the U.S. Department of Agriculture have identified appropriate carcass disposal methods to include burying waste in municipal solid waste landfills (MSWLFs), incineration, alkaline hydrolysis tissue digestion, or on-site burial. The EPA currently recommends using MSWLFs for the large-scale disposal of potentially CWD-contaminated carcasses and wastes.

Carcass waste of animals harvested from areas in Montana where CWD has been detected should be disposed in an MSWLFs. The Montana Department of Environmental Quality, Solid Waste Division, regulates and certifies MSWLFs and has provided a list of Class II sanitary landfills qualified to dispose of potentially CWD-contaminated materials (Table 1). Carcasses and carcass wastes with CWD may also be incinerated when possible. FWP will continue to educate the public, meat processors, taxidermists, and MSWLF operators on the proper disposal of carcasses and carcass parts of cervids. 


Montana Fish, Wildlife, and Parks’ CWD surveillance plan will efficiently use finite resources of staff and funding to maximize our ability to detect CWD in areas where it is not known to exist. This entails

(1) continuing to test any symptomatic cervid (deer, elk, or moose) statewide,

(2) focusing systematic surveillance primarily on mule deer, the most susceptible species within Montana, and

(3) employing a weighted surveillance strategy aimed at detecting 1% CWD prevalence with 95% confidence that rotates among high-priority CWD surveillance areas.

Samples will be collected from symptomatic animals, animals necropsied from research projects, hunter harvested animals, and road-killed animals. This effort will require (1) hiring five temporary technicians (one for 32 weeks, and four for 16 weeks, roughly starting Sept 1) to assist with sample collection and processing, and (2) increased educational outreach during hunting seasons. In addition, there will be an increase in overall testing costs to accommodate the extra volume of samples. FWP Wildlife Health Program staff and the technicians (supervised by the Disease Ecologist) will be primarily responsible for implementing the surveillance program with additional support from regional staff. Hunters who harvest animals outside of a surveillance area and want to have their animal tested may submit their own samples and pay the testing costs and will be asked to share test results with FWP.

High priority surveillance areas, which also include the area surrounding Philipsburg, where Montana had its only recorded case of CWD at a captive game farm in 1999. Since CWD could be spread through the inadvertent or illegal movement of a CWD-positive cervid carcass into the state or from CWD-positive areas within Montana, we will formally survey additional areas of the state outside of the high priority surveillance zones. Moreover, priority surveillance areas may change based on CWD detections within Montana. Surveillance Zones are established by UN. Montana has divided the state in two for economic reasons so that if infected one part of the state could conduct global trade while the other would be in quarantine.

My suggestions stock up on food and know how to garden and hunt.

And in the worse case we may depend upon manna from heaven.




Celeste Solum is a broadcaster, author, former government, organic farmer and is trained in nursing and environmental medicine going where angels fear to tread.

KeyNote Speaker True Legends, Red Pill, and Buffalo Base Camp

Celeste chronicles the space and earth conditions that trigger the rise and fall of modern & ancient civilizations, calendars, and volatile economies. Cycles are converging, all pointing to a cataclysmic period between 2020 to 2050 in what many scientists believe is an Extinction Level Event.

  • Tracking goods and people will be a part of managing the population during this convergence.
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  • Plans and Exercises
  • Deep-Dives coverage where angels fear to tread

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