Showing posts with label APHIS. Show all posts
Showing posts with label APHIS. Show all posts

Thursday, June 21, 2018

Agricultural Law Weekly Review - June 21, 2018

Written by:
Jackie Schweichler – Education Programs Coordinator

The following information is an update of recent local, state, national, and international legal developments relevant to agriculture.

Dairy Policy: Dairy Margin Protection Program Application Deadline is Extended
On June 13, 2018, the U.S. Department of Agriculture (USDA) Farm Service Agency (FSA) announced that the re-enrollment deadline for the dairy Margin Protection Program (MPP) will be extended until June 22, 2018. The deadline has been extended to give producers more time to consider the MPP and the new provisions made under the Bipartisan Budget Act of 2018. The purpose of the MPP is to protect participating dairy producers when the margin between the price of milk and feed costs falls below certain levels. For more information on this program, see the FSA webpage.

Pesticides: California Court Denies Bid to Change Preliminary Injunction for Glyphosate Warning Label
On June 12, 2018, the U.S. District Court for Eastern California denied a motion to alter a preliminary injunction against the application of Proposition 65 (Prop 65) for glyphosate (National Association of Wheat Growers, et al. v. California, CIV. NO. 2:17-2401 WBS EFB).  Proposition 65 requires warning labels for any chemicals known by the state of California to cause cancer, and glyphosate is now on the Prop 65 list. This lawsuit was brought against California by several producers who argue that there is limited, if any, evidence that glyphosate causes cancer. On February 26, 2018, the District Court issued a preliminary injunction against the state so that producers would not need to comply with Proposition 65 for the time being. In the most recent court order, the court determined that the injunction would stand because the state was unable to present new evidence, and there was no clear error by the court in the issuance of the prior order.

Farm Bill: Senate Agriculture Committee Passes 2018 Farm Bill
On June 13, 2018, the U.S. Senate Agriculture Committee voted on and passed the Agriculture Improvement Act of 2018, more commonly known as the farm bill. The bill passed by a vote of 20 to 1 and will now go to the full U.S. Senate for consideration. According to the U.S. Department of Agriculture (USDA), the new legislation will promote crop insurance, support conservation programs, encourage farming, improve market competitiveness, support nutrition assistance, protect the integrity of organic certified products, improve biosecurity, protect public health, encourage food safety programs, and more.

Invasive Species: APHIS Announces Quarantine in New York for European Cherry Fruit Fly
On June 14, 2018, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced a quarantine for the European cherry fruit fly in areas of New York state. The fly attacks ripening fruit, generally sweet cherries, which causes the fruit to rot. European cherry fly infestation can cause 100 percent destruction of the host plant. APHIS has published pest response guidelines for the fly. Control methods include foliar bait spray treatments, soil drenching, and removal of all fruit. The area in quarantine consists of 92 square miles of Niagara County. Residents have been asked to consume homegrown cherries on site and not move the fruit from their property.

Food Safety: FDA Issues Draft Guidance for PC Animal Food Rule
On June 14, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to help facilities needing a supply-chain program meet the requirements under the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food rule). The rule adds requirements for specific domestic and foreign animal food facilities to establish hazard analysis and risk-based preventive controls for food for animals. The purpose of the rule is to ensure animal food safety to avoid illness for both humans and animals. The draft guidance is intended to help producers determine whether they need a supply-chain program, identify and implement the required approval process, establish frequency of supplier verification activities, meet documentation requirements, and provide general clarification.

Food Safety: FDA to Hold Public Meeting on Cultured Food Products
On June 15, 2018, the U.S. Food and Drug Administration (FDA) announced a public meeting set for July 12th to discuss food innovation and “cultured” food products. Cultured food products can be made from cells collected from animals and are intended to resemble conventional meat, poultry, and seafood. FDA states that they are evaluating and working to establish safety guidelines and hope to foster dialogue regarding various areas of regulation, including labeling.  The meeting, entitled “Food Produced Using Animal Cell Culture Technology” will take place at the Center for Food Safety and Applied Nutrition in College Park, MD.

Food Policy: FDA Issues Guidance on Eight Additional Dietary Fibers
On June 14, 2018, the U.S. Food and Drug Administration (FDA) issued guidance and a supporting science review for eight non-digestible carbohydrates (NDCs) which FDA intends to include under the definition of dietary fiber. The NDCs include “mixed plant cell wall fibers; arabinoxylan; alginate; inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/dextrin.” The FDA intends to exercise enforcement discretion if any of these eight NDCs are used on food labels prior to the completion of FDA’s rulemaking.  The guidance can be found on the FDA website, and is entitled,  The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry.  

From National Ag Law Experts:
Does Grazing Cattle for Years Allow Claim of Adverse Possession?, Tiffany Dowell Lashmet, Texas Agricultural Law Blog, June 18, 2018
Ag Groups File Amicus Brief in WOTUS, Amie Alexander, William H. Bowen School of Law, June 18, 2018

Pennsylvania Notices
Agricultural Advisory Board Meeting Cancellation, the board meeting scheduled for June 28, 2018 has been cancelled; next meeting scheduled for August 16, 2018.

Pennsylvania Legislation
Agriculture and Rural Affairs (H)
SB 2497: An Act providing for amendments to the agricultural land conservation assistance grant program (referred on June 18, 2018)

Local Government (S)
HB 2468: An Act amending Title 26, providing further definitions on limitations for eminent domain of land subject to conservation easement. (first considered June 20, 2018)


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Thursday, April 13, 2017

Agricultural Law Weekly Review—April 13, 2017

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

Right to Farm: PA Court Rules on Application and Storage of Wastewater
On April 4, 2017, the Pennsylvania Superior Court ruled on a case involving a neighbor nuisance suit and the Pennsylvania Right to Farm (RTF) law (Branton v. Nicholas Meat, LLC, 2017 PA Super 88 No. 536 MDA 2016).  The court determined that so long as an agricultural operation “substantially complies with relevant federal, state, and local laws” the agricultural operation still meets RTF’s “lawful” requirement.  Accordingly, the court stated that “a lawful use is not rendered unlawful simply because an owner may have been cited for an infraction for noncompliance in connection with the use.” Additionally, the court held that both the application and storage of food processing waste are normal agricultural operations under RTF.  The court determined, however, that the construction of a 2,400,000 gallon storage tank was a “substantial change” to the agricultural operation.  As a result, because the neighbors brought suit within one year of the change, the case was not barred under RTF.

Packers and Stockyards Act: GIPSA Rule Enforcement is Delayed Six Months  
On April 12, 2017, the Grain Inspection, Packers and Stockyards Administration (GIPSA) published notice in the Federal Register that the agency “is delaying the effective date of the rule published on December 20, 2016, for an additional six months to October 19, 2017” (82 FR 17531).  According to GIPSA, the “rule addresses the scope of sections 202(a) and (b) of the Packers and Stockyards Act, 1921” (81 FR 92566).  GIPSA stated that the delay in the rule’s effective date is “in response to a comment received from a national general farm organization that requested an extension of time and to allow time for further consideration by USDA.”

Litigation: “Pink Slime” Case Moves to Trial
On April 5, 2017, Reuters reported that “ABC Broadcasting has lost a last-ditch bid before South Dakota’s highest court to avoid a trial in a beef producer’s $5.7 billion defamation case over reports about a product that critics call ‘pink slime.’” According to Reuters, Beef Products Inc. (BPI) produces “[l]ean, finely textured beef [which] is made from beef chunks, including trimmings and exposed to tiny bursts of ammonium hydroxide to kill bacteria.”  BPI’s suit alleges that the company was damaged when ABC referred to “BPI’s “lean finely textured beef” product as "pink slime."  Reuters stated that with the recent ruling, the trial is scheduled to begin on June 5, 2017.

Biosecurity: Public Meetings Scheduled Regarding Animal Disease Traceability
On April 3, 2017, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced that the agency will hold “a series of public meetings to receive input on the current Animal Disease Traceability (ADT) system.” According to APHIS, “[t]he meetings will allow APHIS to hear from the public about the successes and challenges of the current ADT framework, specifically for traceability in cattle and bison.”  The meetings are scheduled for the following dates and locations:
April 11: Oklahoma City, OK
April 13: Riverdale, MD
April 20: Nashville, TN
May 2: Bloomington, MN
May 4: Denver, CO
May 11: Rancho Cordova, CA
May 24: Billings, MT  

Federal Administrative Actions and Notices:
Agricultural Department

Environmental Protection Agency

Farm Credit

Food & Drug Administration

Pennsylvania Administrative Actions and Notices:
Department of Environmental Protection

Pennsylvania Legislation:
Senate Agricultural and Rural Affairs
SB 567: Controlled Plant and Noxious Weed Act

AgLaw HotLinks:

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Connect with us on Facebook! Every week we will post the CASL Ledger which details all our publications and activities from the week.


Stay informed with our monthly Agricultural Law Brief located here

Thursday, October 6, 2016

Agricultural Law Weekly Review—October 6, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

GIPSA: Amendment Regarding Electronic Livestock Transactions Sent to President
On October 3, 2016, after unanimous consent by the United States Senate, President Barak Obama was presented with H.R. 5883 which would amend the Packers & Stockyards Act (GIPSA) “to expand the definition of ‘marketing agency’ to include any person engaged in the business of buying or selling livestock in commerce through online, video, or other electronic methods on a commission or other fee basis when handling or providing a means to handle receivables or proceeds from the sale of that livestock.” According to the Bill Summary, H.R. 5883 would also amend GIPSA “to specif[y] that funds for purchasing livestock may be transferred to the account of the seller by electronic funds transfer or any other expeditious method that the Department of Agriculture determines to be appropriate.”

Livestock Trading: AMS to Require Online Cattle Exchange Reporting
On September 29, 2016, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) issued a press release announcing that beginning October 5, 2016, AMS will include “in the National and Regional direct negotiated slaughter cattle reports, cattle purchased through the Fed Cattle Exchange by packers required to report according to the [Livestock Mandatory Reporting] Act and regulation.” According to AMS, the Fed Cattle Exchange was created early in 2016 as an online platform to provide “a web based interface where feedlots can offer pens of market ready cattle for sale, and packers can bid on those offerings in a timed format, similar to an online auction.” AMS stated that the inclusion of the Fed Exchange reports in the National and Regional direct negotiated slaughter cattle reports was at the request of the cattle industry. 

Labeling: FSIS Issues Guidance for Animal Raising Claims
On October 5, 2016, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published notice in the Federal Register “announcing the availability of an updated version of the Agency's compliance guideline on documentation needed to support animal-raising claims on product labels that must be submitted for Agency approval before they can be used on product labels” (81 FR 68933).  Comments on the guidance document must be submitted on or before December 5, 2016.  According to FSIS, although the agency “is requesting comments on this guideline and may update it in response to comments, FSIS encourages establishments that wish to submit request for approvals of animal raising claims on product labels to begin using this guideline.”

Indemnity: APHIS Announces Updated Calculator for Laying Hens
On September 30, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued a press release announcing an update to the agency’s indemnity calculator formula for laying hens.  According to APHIS, the updated indemnity calculator formula “addresses concerns raised by egg layer producers following the 2014-2015 outbreak of highly pathogenic avian influenza (HPAI)” and is intended to “more closely resemble a fair market transaction.” The new APHIS indemnity calculator formula became effective October 1, 2016.

International: U.S. Senate Ratifies Genetic Resources Treaty
On September 28, 2016, the United States Senate passed a resolution of advice and consent ratifying the International Treaty on Plant Genetic Resources for Food and Agriculture adopted by the Food and Agriculture Organization of the United Nations on November 3, 2001, and signed by the United States on November 1, 2002 (the Treaty).  According to the resolution, “[t]he centerpiece of the Treaty is the establishment of a multilateral system under which a party provides access to other parties…to listed plant genetic resources held in national genebanks…solely for purposes of research, breeding, and training in agriculture.”


Friday, February 19, 2016

Agricultural Law Weekly Review: February 19, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

GE Crops: APHIS Publishes Notice of Intent to Deregulate Monsanto GE Maize 
On February 17, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register regarding Monsanto Co.’s request to deregulate genetically engineered (GE) maize designated as event MON 87419.  According to the published notice, “APHIS has determined that maize designated as event MON 87419 is unlikely to pose a plant pest risk” and as a result, APHIS has made “a preliminary determination of nonregulated status of maize designated as event MON 87419.” Comments on the published notice will be received for 30 days from the date of publishing in the Federal Register. 

Raw Milk:  FDA Announces Reevaluation of Testing of Raw Milk Cheese 
On February 8, 2016, the United States Food and Drug Administration (FDA) issued a press release announcing that FDA will reevaluate the testing of raw milk cheese for non-toxigenic E. coli.  The press release stated that FDA was responding to concerns raised by cheese makers “suggesting that the FDA is applying safety criteria that may, in effect, limit the production of raw milk cheese without demonstrably benefiting public health.” According to the press release, FDA “will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese but, in the meantime, FDA is in the process of pausing its testing program for non-toxigenic E. coli in cheese.”

Labeling: Court Affirms Federal Authority over Meat and Poultry Labeling 
On February 12, 2016, the United States Court of Appeals for the Ninth Circuit affirmed a lower court ruling that California was barred from “enforcement of California’s statutory prohibition against nonfunctional slack fill (i.e., empty space between a product and its packaging that serves none of a list of specified purposes)…as applied to meat and poultry products” (Case No. 13-16893).  The Court held that “California’s nonfunctional slack fill provisions…are expressly preempted by the Federal Meat Inspection Act (“FMIA”) and the Poultry Products Inspection Act (“PPIA”)” and that “Congress intended to allow meat and poultry packaging to be subject to less specific regulation than other types of product packaging.”

Labor: Class Action Brought Against Meat Processor over Employment of Illegal Workers 
On February 16, 2016, a class action lawsuit was filed in the United States District Court for the Northern District of India on behalf of hourly-paid production workers at the Indiana Packers Company’s (IPC) meat processing facility (Case No. 4:16-cv-00015-JD-JEM).  The class action lawsuit was brought pursuant to the Racketeer Influenced and Corrupt Organizations Act (RICO) and alleged that IPC engaged in “a scheme to employ vast numbers of illegal immigrants at the plant [in an effort] to depress wages.” According to the filed complaint, IPC carried out its “scheme” by knowingly hiring illegal workers and making false attestations on I-9 Forms that the illegal workers were authorized for employment in the United States.

SNAP: USDA Proposes Rule to Require Healthier Choices 
On February 17, 2016, the United States Department of Agriculture (USDA) published a proposed rule in the Federal Register “to make changes to the Supplemental Nutrition Assistance Program (SNAP) regulations pertaining to the eligibility of SNAP retail food stores.”  According to the proposed rule, SNAP-authorized retailer food stores will be required to stock a wide variety of healthy foods so that SNAP program recipients will be provided with increased access to healthy food options.  Comments on the proposed rule will be received for 60 days from the date of publishing in the Federal Register.

Thursday, February 11, 2016

HPAI Update: New HPAI Indemnity Payment Rule becomes Effective

Written by M. Sean High – Staff Attorney

On February 9, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published in the Federal Register an interim rule amending the regulations governing the payment of indemnity claims for highly pathogenic avian influenza (HPAI) (81 FR 6745).  The new regulations became effective upon the interim rule’s February 9, 2016 publication in the Federal Register.

The February 9, 2016 interim rule amends the previous HPAI indemnity regulations in three ways: 1) APHIS is allowed to split indemnity payments between poultry/egg owners and contractors; 2) existing policy is clarified through language providing for indemnity payments for eggs destroyed as a result of HPAI; and 3) poultry/egg owners and contractors of large facilities must each provide statements that prior to the detection of HPAI in their facility, they had in place, and were following, a biosecurity plan.

By way of authority, APHIS administers HPAI indemnity payments under 9 CFR 53.  Prior to the February 9, 2016 interim rule, 9 CFR 53 allowed indemnity payments for the costs of purchase, destruction, and disposal of animals and materials required to be destroyed due to HPAI contamination or exposure, but did not specify that an indemnity payment could be divided between a poultry/egg owner and a contractor.

Relatedly, a similar problem previously existed regarding Low Pathogenic Avian Influenza (LPAI).  In 2002, after an LPAI outbreak in Virginia, 9 CFR 56, which governs APHIS LPAI indemnity payments, was amended to allow indemnity payments to both animal owners and contractors (9 CFR 56.8).

Now, because of the February 9, 2016 interim rule, the formula used in 9 CFR 56.8 for dividing LPAI indemnity payments between animal owners and contractors has been incorporated to apply to HPAI (9 CFR 53.11).  As a result, APHIS may now pay a contractor indemnity for their losses associated with HPAI.  Accordingly, after indemnity is paid to a contractor (based on the 9 CFR 53.11 formula), the poultry/egg owner is then eligible to receive the remaining indemnity balance.

Prior to the February 9, 2016 interim rule, as a matter of policy, APHIS included eggs under the general term “materials” for purposes of indemnity payments.  Seeking to provide clarity on the matter, 9 CFR 53 now specifically makes reference to eggs and provides direction for the appraisal value of eggs destroyed due to HPAI (9 CFR 53.3(e)).

Finally, the February 9, 2016 interim rule now requires that for indemnity payment eligibility, both poultry/egg owners and contractors must provide APHIS with a statement that at the time HPAI was detected in their facility, they had in place, and were following, a biosecurity plan.  As a result, barring an exemption, indemnity claims will be denied without these statements (9 CFR 53.10(g)).

Under 9 CFR 53.10(g), only large poultry operations must comply with the biosecurity requirement.  Accordingly, poultry facilities are exempted from issuing the biosecurity statements if the operation is: 1) a commercial table egg facility with fewer than 75,000 birds; 2) a facility that raises for release upland game birds and has fewer than 25,000 upland game birds annually; 3) a facility that raises for release water fowl and has fewer than 25,000 water fowl birds annually; 4) a broiler facility that raises fewer than 100,000 broilers annually; or 5) a meat turkey facility that raises fewer than 30,000 turkeys annually. 

APHIS has stated that the purpose of the February 9, 2016 interim rule was “to solidify policies surrounding the payment of indemnity and further strengthen biosecurity adherence at poultry operations.” The comment period on the interim rule ends April 11, 2016.  

Wednesday, December 16, 2015

USDA Requires Permitting of Genetically Engineered Wheat


Written by M. Sean High – Staff Attorney

On December 11, 2015, the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) announced that beginning January 1, 2016, all field trials of regulated genetically engineered (GE) wheat must be conducted under USDA’s permitting process.  Prior to the announcement, field trials of GE wheat had been conducted under USDA’s less stringent notification process.  USDA-APHIS stated that “recent unauthorized releases of GE wheat and findings have led USDA-APHIS to the conclusion that U.S. agriculture would benefit from the increased oversight provided by the Permit process.”

Accordingto USDA-APHIS, during 2013-2014, two separate incidents of unauthorized GE wheat were discovered in Oregon and Montana.  The Oregon GE wheat field trial had never been authorized at the discovered site and authorization for the discovered Montana GE wheat field trial site had expired 10 years prior.  USDA-APHIS voiced concern that these detections “had great potential to disrupt wheat markets globally” and that some U.S. trading partners have imposed “risk mitigation measures to imports of U.S. wheat in response to [the Oregon] incident.”

USDA-APHIS stated that “[u]sing permits for field trials of GE wheat provides an additional level of safeguarding based on, and consistent with the technology of wheat.” Furthermore, the agency exclaimed that “[b]ringing GE wheat under permit enables APHIS to create and enforce permit conditions that minimize the likelihood that the regulated GE wheat will spread or persist in the environment.” Importantly, USDA-APHIS noted that through the more stringent permitting process, international trading partners will be reassured “that the U.S. is committed to being the world’s reliable supplier of grain.”   

Tuesday, November 17, 2015

U.S. Senators Seek HPAI Protections

Written by M. Sean High

On November 5, 2015, ten U.S. senators issued a letter to U.S. Department of Agriculture (USDA) Secretary Tom Vilsack regarding USDA’s development of its Fall 2015 Highly Pathogenic Avian Influenza (HPAI) Preparedness and Response Plan.  The ten senators signing onto the letter were: Thad Cochran (R-MS), Jeff Sessions (R-AL), David Vitter (R-LA), John Boozman (R-AR), Tom Cotton (R-AR), Richard Shelby (R-AL), Johnny Isakson (R-GA), Roger Wicker (R-MS), Bill Cassidy (R-LA), and David Purdue (R-GA).

According to the senators’ letter, three matters are of particular importance and should be addressed in the regulatory development process being conducted by USDA through its Animal and Plant Health Inspection Service (APHIS).

First, the senators stated that current APHIS regulations “do not allow for the splitting of indemnity payments between owners and growers.” As a result, the senators argue that many contract growers are left “vulnerable in the event of [an HPAI] outbreak.” In an effort to provide protection for these contract growers, the senators “request[ed] that [APHIS] allocate any future indemnity equitably so that producers can maintain access to financing in the short-term and the future.”

Second, the senators stated that current APIHS regulations only permit indemnity for losses associated with bird mortality and not for losses associated with disruptions in the supply chain.  Specifically, the senators stated that “[e]ven if the birds in a particular facility do not contract HPAI, that producer could be affected by a hatchery outbreak.” Accordingly, the senators requested that APHIS consider providing producers with “downtime compensation.”  


Third, the senators stated that “it is important for growers to have expanded financial flexibility” to avoid the possibility of HPAI induced foreclosures.  To accomplish this goal, the senators requested that USDA “direct the Farm Service Agency to begin developing guidelines for its direct and guaranteed loan programs that would enable existing loans to be restructured to provide flexibility for borrowers severely affected by HPAI.”   

Tuesday, November 3, 2015

HPAI Trade Restrictions Still Linger

Written by Tyler R. Etter

Although the United States outbreak of highly pathogenic avian influenza (HPAI) has been controlled,
and clean-up efforts are nearly finished, trade partners are still restricting the imports of U.S. poultry.

Most of the 18 nations that banned all U.S. poultry have maintained these restrictions, causing nearly
$900 million in lost trade. There are yet another 38 nations with regional restrictions, costing a total of
$4.5 billion to the poultry industry, which constituted 69% of trade in 2014.

Dr. Lisa Ferguson of the Animal and Plant Health Inspection Service (APHIS) stated that APHIS is
currently visiting trading partners in Asia, Africa, and the Middle East. APHIS is updating the nations on
the plan to face any potential avian influenza this fall, as well as issues of vaccination. The primary goal is
to emphasize that the outbreak is under control, and to encourage the nations to lift the trade
restrictions.

Initially trading partners were suspicious of the vaccination of birds, as they believed it showed a lack of
control over the outbreak. Dr. Ferguson stated that as the vaccination strategy, of using vaccines only
when the disease is rapidly spreading in high-density areas, such as the impacts in Minnesota and Iowa.

Minnesota and Iowa are reported to be the only states where cleaning and disinfection are still taking
place. The World Organization of Animal Health will require a 90-Day waiting period after these
processes are completed before trade restrictions can be lifted.

Wednesday, October 28, 2015

APHIS Deregulates Genetically Engineered Monsanto Corn

Written by Katharine Richter

On October 27, 2015, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the federal register of its decision to deregulate a genetically engineered corn created by Monsanto Company.  The corn is engineered to protect against rootworm and for resistance to the herbicide glyphosate. 

Under 7 CFR part 340, APHIS is authorized to regulate genetically modified products that are plant pests or there is reason to believe they may be plant pests and are considered “regulated articles.”  Significantly, 7 CFR § 340.6(a), allows for the submission of a petition to APHIS which can have the product removed from regulated status. 


Accordingly, Monsanto sent in a petition for the deregulation of corn variety they designated as MON 87411.  Based on Monsanto field studies and laboratory analyses, Monsanto concluded MON 87411 should not be considered a plant pest under § 340.  APHIS conducted a plant pest risk assessment (PPRA) and environmental assessment (EA), and based upon its findings concluded the new corn strain was unlikely “to pose a plant pest risk to agriculture and other plants in the United States,” and “deregulation is not likely to have a significant impact on the human environment."

Wednesday, October 14, 2015

APHIS Environmental Assessment of HPAI Vaccine Finds No Impact

Written by Katharine Richter

On October 7, 2015, Animal and Plant Health Inspection Service (APHIS) issued a notice of the environmental assessment (EA) of Avian Influenza H5 vaccines has been prepared.  The notice stated that “based on the environmental assessment . . . use of vaccines . . . will have no significant impact on the human environment.”

The notice states that “under the Virus-Serum-Toxin Act (21 U.S.C. 151 et. seq.), APHIS is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious.”  The notice highlights the December 2014 outbreak of highly pathogenic avian influenza (HPAI) and the devastating affects it had on the poultry industry.  The hardest hit sectors of the poultry industry was commercial meat turkeys and laying hens, with the total loss of “over 48 million birds between December 2014 and June 2015.”    

APHIS states that after the comment period closes, if the comments raise issues not previously considered, APHIS will issue a supplement to the EA.  Given that timeliness is so crucial with the cold weather setting back in, APHIS is aiming to authorize shipment and field use of the vaccine as quickly as possible, potentially before the close of the comment period.


The public comment period regarding the environmental assessment will be open until November 6, 2015. 

Thursday, September 24, 2015

APHIS Releases HPAI Preparedness and Response Plan

Written by Tyler R. Etter

On September 18, 2015, the Animal and Plant Health Inspection Service (APHIS) released a report
detailing the planning and preparations for highly pathogenic avian influenza (HPAI) in the event that
outbreaks continue this coming fall after flocks migrate south.

The HPAI outbreak that took place in the winter of 2014 and spring of 2015 affected more than 48.8
million birds over 21 states. The last detection of the disease was on June 17. The new response plan is
based on a hypothetical “worst case scenario.”

The plan focuses on four key areas: preventing or reducing outbreaks, enhancing preparedness,
improving and streamlining response capabilities, and preparing for the potential use of AI vaccines.
Updates include improved self-assessments for biosecurity for the poultry industry and a draft strategy
for the use of vaccines.

Of particular note are the planned improvements to indemnity payments for flock depopulation. Flock
plans are now to be submitted later in the process, making the 24 hour depopulation goal more realistic.
Further, there is a planned interim rule that will allow for a split of indemnity payments between the
poultry owner and the contract grower.

APHIS has utilized the information and lessons learned from the previous outbreak in developing this
plan. APHIS is confident in its preparedness for the coming fall, and is ready to respond and aid those
affected by the disease. The full report can be read here.

Tuesday, September 1, 2015

APHIS Updates HPAI Response Materials

Written by M. Sean High

On August 31, 2015, the United States Department of Agriculture Animal and Plant Health Inspection Service (APHIS) posted an update to the agency’s Highly Pathogenic Avian Influenza (HPAI) response documents.  Titled ContactPremises, this latest document reflects a concerted effort by APHIS to proactively deal with HPAI issues.

According to APHIS, a location is deemed a Contact Premise when that location is determined to “have susceptible poultry that may have been exposed to the highly pathogenic avian influenza (HPAI) virus, either directly or indirectly, including but not limited to exposure to susceptible poultry, poultry products, fomites, or people from Infected Premises.”

According to the Contract Premises document, a Contact Premises is identified through the tracing-back or tracing-forward of all movements (human, vehicle, animal, etc.) from HPAI Infected Premises.  If a Contract Premise is identified, depopulation may be authorized where HPAI is suspected.  A positive HPAI test not required.

Furthermore, APHIS will provide indemnity for the depopulation of Contact Premises poultry flocks that have been properly authorized for depopulated by APHIS and state officials.  The information necessary for indemnity will be collected from barn records after a Contact Premise is identified through movement tracing, and prior to an epidemiological investigation and any subsequent flock depopulation.

Monday, August 31, 2015

APHIS Approves GMO Potato

Written by Katharine Richter

On August 28, 2015, Animal and Plant Health Inspection Service (APHIS) approved a request by J.R. Simplot Company “seeking a determination of nonregulated status of potatoes (Solanum tuberosum) designated as Innate W8.” 

According to The Simplot Co. press release, the second generation Innate potatoes are genetically modified to provide four traits that are beneficial, which are “1) Reduced bruising and black spots; 2) Reduced asparagine; 3) resistance to Late Blight pathogens; and 4) Enhanced cold storage capability.”

During the public comment period regarding the request for deregulation, the concerns raised regarded potential cross contamination with conventional potatoes, trade issues due to “unwanted genetically engineered commodities in exports,” request for more research, and potential environmental and human health concerns.


 APHIS final environmental assessment and plant pest risk assessment based on all information received concluded “…Simplot’s Innate Potato designated as Russet Burbank event W8 is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the introduction of certain GE organisms.” 

Wednesday, August 26, 2015

APHIS Issues Draft Mass Carcass Management Policy

Written by Katharine Richter

On August 14, 2015, the United States Department of Agriculture (USDA) Animal and Plant Inspection Service (APHIS) released a draft environmental impact statement (EIS) titled, “Carcass Management During a Mass Animal Health Emergency.”

The draft EIS was created to help “APHIS [] effectively manage livestock carcasses in a mass animal health emergency to reduce potential risks to humans, animal, and environmental health.”
 
APHIS presents three options on handling animal carcasses which are labelled as no action alternative, standard procedures alternative, and adaptive management alternative.  Under the no action alternative, APHIS would continue handling the carcasses using either “unlined burial or open-air burning.”  Under the standard procedures alternative, APHIS would allow four additional disposal options than the no action option.  The additional options would be “…composting, rendering, landfills compliant with the Resource Conservation and Recovery Act (RCRA) and/or fixed-facility incineration…”  The final option is the adaptive management alternative which would allow “all available carcass management options to be considered and potentially used during a mass animal health emergency.”


The draft EIS analyzes each of these approaches potential environmental impact in regards to a variety of topics including soil quality, air quality, water quality, vegetation and human health.  Although this draft was created before the 2014 outbreak of HPAI, it will impact how potential future outbreaks are handled.  The draft EIS comment period will be open to the public for 60 days.