Spotlight on Compliance of Wood Products

By Elliot Belilos

In the wake of the recent 60 Minutes piece that highlighted alleged elevated formaldehyde in the Chinese-made wood flooring imported by Lumber Liquidators, all manufacturers and importers of consumer products containing compressed wood need to ensure that their products comply with the California Air Resources Board (CARB) limits regarding formaldehyde emissions.  And while the formaldehyde limits now only apply to products sold in California, those limits are soon to become the law nationwide, as EPA is finalizing regulations (expected by the end of the year) that largely parallel the CARB regulations.  The EPA regulations are being promulgated under 2013 amendments to the Toxic Substances Control Act.  All consumer goods that contain hardwood plywood (HWPW), particleboard (PB), medium density fiberboard (MDF) are affected.

Reasonable Prudent Precautions

For importers of HWPW, PB and MDF and finished products containing these materials, the Airborne Toxic Control Measures (ATCM) imposes no obligation to test, but importers must take “reasonable prudent precautions” to ensure that the products are compliant, which at a minimum, requires the importer to instruct (in writing) each supplier that the goods it supplies to the importer comply with the applicable emission standards, and obtain written documentation from each supplier that this is so. ATCM § 93120.6(b). In addition to certification from the supplier that all composite wood components are CARB 2 compliant, it would be advisable to require suppliers of products with composite wood components to provide copies of test reports that demonstrate CARB 2 compliance. Since the manufacturer is required to test for CARB 2 compliance, those test reports should be available – if not available, that should at least raise a red flag.

Recordkeeping Requirements

Importers of finished goods containing composite wood components must maintain records showing the date of purchase and the supplier of each shipment of goods containing HWPW, PB or MDF and document the precautions taken to ensure that the composite wood in the finished goods comply with applicable emission standards. These records must be kept in electronic of hard copy form for a minimum of two years and provided to CARB or local air district personnel upon request. ATCM § 93120.6(b).

Statement of Compliance

For each composite wood product or finished good made with composite wood, the importer must state on the bill of lading or invoice that the composite wood products or components comply with the CARB 2 emission standards.

Facility Inspections

Importers may be inspected by CARB or local air district personnel. In the course of an inspection, the importer may be subject to a records audit and product sampling.

Verification Testing

As noted above, there is no requirement that importers conduct independent testing of composite wood components of finished goods. Nonetheless, an importer of composite wood products or finished goods with composite wood components is still at risk for penalties even if it takes the “reasonable prudent precautions” described above. Those reasonable prudent precautions may serve to mitigate penalties levied by CARB, but penalties could still be levied if CARB were to determine that the composite wood is not compliant despite the certification and test reports provided by the supplier.  As a result, it may help to further mitigate potential liability to conduct some independent testing to confirm compliance.

In addition to the potential liability Lumber Liquidators is facing regarding alleged CARB emissions noncompliance, the Justice Department recently announced that it is investigating whether the Company violated the Lacey Act by importing endangered species of wood and the U.S. Consumer Product Safety Commission (CPSC) is investigating whether the Company’s products run afoul of CPSC regulations.

If you are a manufacturer or importer of consumer products that contain wood, it is important that you understand the laws and regulations that affect your products.  In the wake of the investigations surrounding Lumber Liquidators, your products are in the regulatory spotlight.

Elliot Belilos represents companies in the areas of product safety and compliance.  You can reach him at ebelilos@ofwlaw.com.

No Horsing Around – Nevada Federal Judge Dismisses Burro Suit Against Interior Dept.

By Stewart D. Fried

The serious environmental problems caused by unchecked wild horse populations on western rangelands are well known to state and local governments, Native American tribes, ranchers and farmers.  Efforts, however, to prompt the U.S. Department of Interior (“Interior Dept.”) and its Bureau of Land Management (“BLM”) to address widespread environmental damage and other impacts caused by wild horse overpopulation have been largely unsuccessful.  Environmental and other issues caused by thousands of wild horses on federal lands are perhaps most pronounced in Nevada.  The Silver State is estimated to be home to nearly half of the country’s wild horse population.   Because BLM is not doing enough to address exponential population growth, wild horse herd sizes are increasing by 20% annually.

The Wild Free-Roaming Horse and Burros Act, 16 U.S.C. §1331 et seq., (“Wild Horse Act”) governs the Interior Dept.’s duties with respect to wild horses on federal lands.  The Wild Horse Act mandates that the Interior Dept. protect and manage wild horses and burros, including the responsibility to “maintain a current inventory of wild free-roaming horses and burros on given areas of the public lands.” 16 U.S.C. §1333(b)(1).  Under the Wild Horse Act, a “natural ecological balance” among wild horse and burro populations, domestic livestock, wildlife and vegetation must be achieved.

In order to achieve that balance, the Interior Dept. determines whether Appropriate Management Levels (“AMLs”) should be achieved by the removal or destruction of excess animals.  BLM describes as “the number of wild horses and burros which can graze without causing damage to the range.”  In establishing AMLs, BLM relies on studies of grazing utilization, trends in range condition, weather data and other factors.  BLM also takes into consideration populations of wildlife, permitted livestock and wild horses and burros in the area. Id.  BLM sets AMLs following public involvement through an in-depth environmental analysis and decision process. Id.  In enacting the Wild Horse Act, Congress expressly required the Interior Dept. to “immediately remove excess animals” from the range so as to achieve AMLs when it is determined that “an overpopulation exists on a given area of the public lands and that action is necessary to remove excess animals.”  16 U.S.C. §1333(b)(2).

With these seemingly clear statutory mandates in mind, several Nevada counties, farming and ranching associations and other interested parties have attempted, with limited success, to prompt BLM to address the problem of wild horse overpopulation on Nevada rangelands.  Based on BLM’s inaction and ever-worsening damage to public resources and increased threats to private water rights, the Nevada Association of Counties and the Nevada Farm Bureau (“Counties”) sued the Interior Dept. in federal court in Reno during December 2013, alleging constitutional violations and seeking judicial review under the Administrative Procedures Act (“APA”).

On February 12, 2015, Federal District Court Judge Miranda Du issued her opinion in Nevada Association of Counties v. Interior Dept., dismissing the Counties’ complaint with prejudice.  Judge Du concluded that she lacked subject matter jurisdiction over the case because the Plaintiffs’ amended complaint “failed to identify a final agency decision” by BLM that was being challenged.  The Court noted that the Wild Horse Act does not provide for a private cause of action and that any challenge to federal action brought under the APA must be based either on “final agency action that warrants judicial review or any inaction that may be compelled.”  Order, at 4.

The crux of the Court’s decision was founded on its determination that the plaintiffs “sought review of flaws in the entire program” to “compel compliance with the Act and refashion [BLM’s] management of wild horses and burros in Nevada.” Id., at 7.  In describing the Counties’ lawsuit as a “programmatic attack” on the entire BLM program, the Court focused on the Plaintiffs’ failure to allege that BLM failed to set “a single AML or inventory” or any another specific final agency action.  Judge Du also dismissed the Counties’ constitutional claims because the amended complaint failed to allege a property interest that was taken or otherwise affected by BLM’s mismanagement of wild horses, or how BLM’s responses to the Plaintiffs’ notices that wild horses were outside designated management areas or were interfering with water access fell short of due process.

The dismissal of the Counties’ lawsuit is the latest chapter in a lengthy and still unfinished book about wild horses on the Western range.  Although BLM has removed over 100,000 wild horses during the past decade from federal lands, the equine overpopulation problem continues to expand in every state and most tribal lands from the Cascades to the Mexican border.  Congress has again foreclosed horse slaughter as an option for reducing herd size, despite a thriving market abroad and several domestic facilities that received (or were eligible to receive) FSIS grants of inspection during 2012.  While an appeal of the decision is possible, this is likely an uphill battle it would need to be filed in the generally unfriendly Ninth Circuit Court of Appeal.

In light of the District Court’s decision, states, tribes and other stakeholders may need to go back to the drawing board.  Because Judge Du took issue with the Plaintiffs’ failure to identify particular BLM decisions with respect to specific inventories or AMLs, next steps could include identification of specific herd management areas where BLM has failed to conduct inventories or set AMLs or identifying herd management areas where severe erosion and other ecological damage exists, conducting wild horse herd population surveys in those areas (assuming data does not already exist), and then filing petitions with BLM seeking the establishment of inventories or AMLs and demanding that the Bureau conduct removal activities in accordance with the Wild Horse Act.  This will take considerable time and effort, all while wild horse populations will continue to increase and environmental and other harms from equine foraging, especially to water quality, will not be addressed.  What is clear is that there likely will be no swift resolution to the environmental and animal welfare problems associated with this hotly-debated symbol of the West.

A copy of the District Court’s decision in Nevada Association of Counties v. U.S. Department of Interior can be found here.

114th Congress – What to Expect in Ag and Food

By Michael J. Marshall

As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress.

Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all.  With just two years to go in his final term, President Obama seems determined to push his agenda on a number of fronts. Nevertheless, Americans tend to be eternal optimists, so many are hoping the Administration and Congress will be able to compromise on at least some important issues.  Exactly what is open for negotiation remains to be seen.

In my post-election blog, I asked, “What now?” and answered my own question with, “quite a lot.”  We can’t entirely predict which cards the President will ultimately choose to play.   We’ve already seen him out of the gates early on immigration and Cuba policy, both of which are of great interest to agriculture.

There are a few fig leaves being exchanged.  At the other end of Pennsylvania Avenue, Senate Majority Leader Mitch McConnell (R-KY) doesn’t appear to be too bent out of shape yet.  He is keeping his composure, says he doesn’t take politics personally, and may be interested in sharing Kentucky Bourbon with the President.  Would Joe Biden be there for the Bourbon Summit like he was for the Beer Summit?

My colleagues and I were sitting around last week handicapping the year ahead with our esteemed colleague, former Secretary of Agriculture Jack Block, who served under President Reagan and has seen a few turnovers in this town.  With his own tone of optimism, he advised, in essence, “Pay attention, stay alert, do your work, because when things are moving, you never know when something might actually pass that the President will sign.  Strange things do happen.”

OFW is taking a close look at the prospects for action across a broad range of issues that affect agriculture and food, areas where there has traditionally been bipartisanship, but also ones that may be affected by other reforms. There are a number of issues that have the potential to move.  Here are a few:

Trade

Trade is at the top of the agenda on almost everyone’s list, and appears to be within the realm of the possible despite some significant obstacles.  The impact of a U.S.-Asia Trans-Pacific Partnership (TPP) trade deal, a U.S.-Europe Transatlantic Trade and Investment Partnership (TTIP) deal, and/or Fast Track Trade Promotion Authority, which would make it easier for the Executive Branch to negotiate trade agreements, would be enormous in terms of opening markets for the entire food and Ag value chain.

We can expect the Generalized System of Preferences, which cuts tariffs on goods from developing countries, maybe (hopefully) a Miscellaneous Tariff Bill which would cut duties on agricultural goods not made in the U.S., and almost certainly the reauthorization of the African Growth and Opportunity Act (AGOA) later this year.  Expect the Administration and Congressional Democrats to push for more Trade Adjustment Assistance for workers adversely affected by trade as a pre-condition to move these initiatives forward.  The World Trade Organization (WTO) will consider the U.S. appeal of an adverse country of origin labeling (COOL) ruling. That appeal will require the USDA to submit recommendations, and this could be met with Congressional action to bring the U.S. into international compliance.  If so, the Ag world will be at the table as it was during the omnibus process which resulted in favorable language for producers.

Nutrition/Dietary Guidelines

The “independent” Dietary Guidelines Advisory Committee (DGAC) is expected to release its report to the Secretaries of Agriculture and Health and Human Services this month.  The DGAC report is widely expected to contain some controversial nutritional recommendations and, for the first time, recommendations regarding the sustainability of the food supply.  As many OFW clients know, the DGAC guidance has enormous implications across a broad spectrum of federal programs, from our military to school lunch nutrition standards, to menu and nutrition labeling.

We expect robust debates surrounding added sugars, so-called “high-dose caffeine” beverages, meat, whole grain labeling, sodium, and the mandate for fruits, vegetables and whole grains in the school lunch program.

Environment

One of the elephants in the room inside the Ag community, and I am not talking Republicans, is the role of climate change, or put another way, the environmental impact and sustainability of foods. Notwithstanding language in the recent omnibus suggesting to the DGAC that sustainability is outside the scope of its mandate, no other issue looms larger in the policy sifter within this Administration than the environmental impact of any given policy.  What is the carbon footprint of your Chicken Caesar Salad?  You should know…and some believe it should be listed on the food label.

Expect sustainability to be one of the bases for the dietary recommendations in the DGAC report.  Even if USDA and HHS decide to dial back the Advisory Committee’s ambitions on sustainability, it’s no stretch to say that some in the Administration support the views of the DGAC.

Also, environmentally speaking, we can expect the EPA to continue to look for administrative ways to stretch the Clean Water Act and the Clean Air Act, putting agricultural production in the cross hairs.  If you find a policy that seems immune to the environmental agenda, you can be pretty sure they are working on it.

Food Safety Modernization Act

FDA will issue several of the key regulations implementing FSMA this year, including final rules on preventive controls, fresh produce safety, and foreign supplier verification.  As FDA begins rolling out final rules and enforcing them, Congressional oversight will assume greater importance.  In addition, if the FSMA final rules are promulgated as, or close to, currently written, several segments of the food industry are likely to seek Congressional action on technical amendments to FSMA.

Tax Reform

There is little doubt that tax reform will at least be attempted by Republicans.  While there are too many hurdles that will keep a comprehensive measure from satisfying the President, the Ag world will be looking to extend tax credits for farmers and, if some form of a reform bill does reach the President’s desk, we can expect many players to work to make some of those provisions more permanent.

GMO Labeling

Following Vermont’s passage of a GMO labeling requirement and several close votes on ballot initiatives, we expect the debate over the need for requiring manufacturers to disclose when their foods contain genetically modified ingredients to intensify in Congress this year. This is one of the biggest policy battles playing out for agricultural producers, food manufacturers and, of course, the biotech community.

Expect Republicans to support Rep. Mike Pompeo’s (R-KS) bipartisan Safe and Affordable Food Labeling Act, which would prevent states from setting their own standards and guarantee the authority to label GMOs remains squarely with FDA.  The competing bill, sponsored by Rep. Peter DeFazio (D-OR), would mandate the labeling of all foods containing genetically modified ingredients, a problematic and costly prospect that would have enormous implications for the agriculture supply chain even as the science has consistently shown no material difference between GMOs and their conventional counterparts.  Moreover, the DeFazio bill doesn’t have federal preemption, so GMO detractors would likely continue the push for a state-by-state patchwork of labeling laws that would severely hamper interstate commerce.  A number of Democrats joined Republicans in rallying around Pompeo’s bill at a Dec. 10 hearing of the House Energy and Commerce Health Subcommittee.  While both bills died at the end of the last Congress, they are widely expected to be reintroduced in the 114th.

The worldwide debate over GMOs also rages on.  Biotechnology is a vital tool that the world will need to meet the challenge of global food security, international development goals, the eradication of hunger and extreme poverty, and ironically the environmentalists’ interest in greener agriculture.  While there could be compromise in the area of food labeling, further progress seems unlikely until the scientific facts and public perceptions of GMOs are reconciled.

Feed the Future

The President’s Feed the Future initiative, looking to improve global food security in Africa by boosting agricultural productivity and alleviating extreme poverty and hunger, should be reauthorized with bipartisan support this year.    This will provide a moment of bipartisan comity.

Budget and Appropriations

On top of everything else, budget and appropriations likely completed “in regular order,” as they say around Washington will mean that for the first time in a long time, the President will propose and the Congress will pass spending bills.  Appropriations will follow authorizations of government operations.  The process will be open to amendment and that means everything is on the table, including agricultural entitlements. There will be a reconciliation process when the House and Senate meet to work out differences.

Right off the bat we expect that the numbers that will be given to the Ag Committee will suggest that cuts are coming.  We anticipate a lot of shuffling ahead of this to lessen the impact on one program or the other, but there will not be easy solutions.

Budget positioning will be crucial to our clients as cuts will be needed to conform to the top line.  We expect food stamps (SNAP) and crop insurance to be targeted along with several other programs that the committee will look at in order to fit under the caps.

Happy New Year.  2015 has strong potential to break the pattern of the past several years in many respects.  We’re off to an aggressive start and we can expect it to continue as both the President and Republicans forge ahead and try to demonstrate they can lead.

10 Things to Watch in 2015

By John Dillard

2014 was certainly an interesting year to be involved in agriculture. We got to see supply and demand in full effect. Good weather sent grain prices tumbling while continuing tight supplies have kept cattle prices soaring. The Republicans made strong gains and will enter 2015 with control of both the House and Senate.

While I have not spent the $27.68 necessary to acquire a crystal ball on Amazon, I do feel the need to join the crowded field of writers, bloggers and seers that are making predictions for the upcoming year. Accordingly, I have compiled a list of the 10 legal and policy issues that I see facing agriculture in 2015.

1.  Drones

2014 was supposed to be the year when the Federal Aviation Administration (FAA) would release its proposed rules for integrating commercial drones into the national airspace. Because of this, I received a little flack for leaving drones off of last year’s list. However, FAA has continued to blow past every deadline that it has set for itself. Hopefully, this can be attributed to the agency trying to get the job done right the first time.

I am confident that FAA will release its proposed regulations for small drones (< 55 lbs.) some time in early 2015. The agency has acknowledged that it considers agricultural uses relatively low-risk and it understands that many farmers are moving ahead with adopting the technology regardless of the absence of regulations. Once FAA proposes its regulations for small drones, we’ll have a better idea of how the final rules will look in terms of operator qualifications, aircraft requirements, and allowable operations. This will be welcome news for those looking to capitalize on this new technology and the farmers and consultants that have been “recreationally” monitoring their crops for the past couple years.

2. The “Waters of the U.S.” Rule

While many hoped that Congress would use the recent “CROmnibus” (ugh) bill to stop EPA and the U.S. Corps of Engineers from implementing a broad definition of “waters of the United States,” the legislation failed to do so. This means that EPA and the Corps will continue to move forward on this measure. The agencies received almost half a million comments during the public comment period, with most in opposition to the new power grab. EPA and the Corps are expected to finalize the rule sometime in the first half of 2015. Once the rule is finalized, there will almost certainly be a lawsuit filed to enjoin the rule.

Read the rest of John’s article, “10 Things to Watch in 2015” at AgWeb.com.

Free Webinar on Big Data and Unmanned Aerial Vehicles

OFW Law’s John Dillard will be kicking off this year’s Ohio Food, Agriculture and Environmental Law Webinar Series with a discussion on two cutting-edge topics affecting agriculture: agricultural drones and “big data.” Mr. Dillard’s webinar will provide a brief primer on the current and potential applications for drone technology in agriculture. He will also discuss legal aspects related to drones, including their current regulatory status with the Federal Aviation Administration as well as privacy laws. Next, Mr. Dillard will address privacy issues associated with the emergence of “big data” developed for precision agriculture systems.

The webinar is hosted by Ohio State University’s Extension on Friday, December 12th from 1 PM to 2 PM EST. The live webinar is free and participants will have the opportunity for Q&A. For more information on this webinar, please click here.

jd

 

Risk Communication about Methylmercury in Seafood

By Michael J. O’Flaherty

FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014, at its White Oak Campus in Silver Spring, MD.  The RCAC meeting will focus on messages about the importance of eating adequate amounts of fish and shellfish, while avoiding certain varieties with higher amounts of methylmercury.  Such messages are especially important for women who are pregnant or nursing, and for anyone who prepares food for young children.  Methylmercury is a neurotoxin that can be harmful to the brain and nervous system if a person is exposed to too much of it.

Fish and shellfish are an important part of a healthy diet.  Fish and shellfish contain high-quality protein and other essential nutrients; are low in saturated fat; and contain omega-3 fatty acids.  A well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and children’s proper growth and development. This being the case, women and young children (in particular) should include fish and shellfish in their diets due to the many nutritional benefits.

However, nearly all fish and shellfish contain traces of methylmercury.  For most people, the risk from methylmercury by eating fish and shellfish is not a health concern. However, some fish and shellfish contain higher levels of methylmercury that may harm an unborn baby or young child’s developing nervous system.  The risks from methylmercury in fish and shellfish depend on the amount of fish and shellfish eaten and the levels of methylmercury in these fish and shellfish.

In June 2014, FDA and EPA jointly issued a draft update to their 2004 advice regarding fish and shellfish consumption.  The draft advice essentially encourages pregnant women, those who may become pregnant, breastfeeding mothers, and young children to eat more fish and shellfish, and to select a variety from choices that are lower in methylmercury.  This updated draft advice is consistent with recommendations made in the 2010 Dietary Guidelines for Americans, and is based on a risk assessment that was peer reviewed.

The updated draft advice recommends that pregnant women eat at least 8 ounces (oz) and up to 12 oz (2-3 servings) per week of a variety of fish that are lower in methylmercury to support fetal growth and development.  It cautions pregnant or breastfeeding women to avoid four types of fish that are associated with high methylmercury levels, i.e., tilefish from the Gulf of Mexico, shark, swordfish, and king mackerel.  In addition, it recommends limiting consumption of white (albacore) tuna to 6 oz per week.  Choices lower in methylmercury include some of the most commonly eaten fish, including shrimp, pollock, salmon, canned light tuna, tilapia, catfish, and cod.

The RCAC public meeting is part of FDA/EPA’s efforts to finalize the updated draft advice.  Before issuing final advice, the agencies intend to consider public comments and the advice of FDA’s RCAC, and to conduct a series of focus groups.  Comments on the updated draft advice may be submitted to the FDA docket or by participating in the public meeting.

The RCAC public meeting’s topic, of course, reasonably is relevant to the prospective labeling and advertising interests of fish and shellfish purveyors.

“Eat Your Fish,” Say FDA and EPA

By Robert A. Hahn

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have released draft updated advice on seafood consumption, Fish: What Pregnant Women and Parents Should Know.  The two agencies also published a Federal Register notice creating a docket and requesting public comments on their new fish consumption advice.

The draft updated advice is intended to replace a 2004 document that was seen as discouraging fish consumption by pregnant women.  Many women have avoided eating fish during pregnancy because of concerns about methyl mercury.  However, new science shows that the benefits of fish consumption outweigh the risks, and avoiding fish during pregnancy and childhood means missing out on nutrients important to growth and development.  The draft update also brings FDA and EPA recommendations in line with the 2010 Dietary Guidelines for Americans, as well as other consensus documents on seafood consumption.

The draft update accentuates the positive, emphasizing the benefits of fish consumption and recommending a minimum (not just a maximum) level of consumption.  Its advice is directed primarily to women who are pregnant (or may become pregnant), women who are breastfeeding, and young children, because the nutritional benefits of fish are particularly important for growth and development before birth, in early infancy (for breastfed infants), and in childhood.  However, the agencies state that fish consumption has health benefits for everyone, and therefore the advice should also be followed by the general public.

The key message is to “Eat 8 to 12 ounces of a variety of fish each week from choices that are lower in mercury.”  The word “fish” is used to refer to both finfish and shellfish.  The draft updated advice recommends the following actions:

  1. Eat 8-12 ounces of a variety of fish per week.

This amount represents 2-3 servings of fish per week.  This is far more than most pregnant women currently eat; one survey found mean fish consumption among pregnant women was only 1.8 ounces per week.

Children should also have 2-3 servings of fish per week, but the amount consumed should be reduced to reflect their lower calorie needs: 3-5 ounces for children ages 2 to 8; 4-6 ounces for children ages 6 to 8; and gradually increasing the amount for children over 8 years of age.

  1. Choose fish lower in mercury.

Fish lower in mercury include many common species, such as salmon, shrimp, Pollock, tuna (light canned), tilapia, catfish, and cod.

  1. Avoid the following 4 types of fish: Tilefish from the Gulf of Mexico (not Atlantic tilefish); Shark; Swordfish; and King Mackerel.  In addition, limit white (albacore) tuna to 6 ounces per week.
  1. When eating fish caught from streams, rivers, and lakes, pay attention to fish advisories on those bodies of water.

If such advice is not available for a particular body of water, adults should limit fish from that body of water to 6 ounces per week, and young children should limit consumption to 1-3 ounces per week; both adults and children should then not eat other fish that week.  EPA’s website provides historical data on local fish advisories, but suggests consulting state websites for the most current advisories.

  1. When adding more fish to your diet, be sure to stay within your calorie needs.

FDA and EPA have also released Q&As explaining the draft advice and including a table with the amounts of mercury and omega-3 fatty acids in common species of fish.

FDA and EPA are requesting comments on the draft updated advice and on alternative risk communication approaches for conveying its message.  In addition, the agencies seek comments on the following specific questions:

  • Whether two additional species, orange roughy and marlin, should be added to the list of species of fish to avoid because of methyl mercury.  Orange roughy and marlin have mercury levels that are lower than the four species to avoid listed above, but higher than nearly all other commercial fish.  In addition, they are low in omega-3 fatty acids;
  • Whether the final advice should track the language of the 2010 Dietary Guidelines more or less closely than the draft;
  • Any new science relevant to the draft updated advice;
  • Information upon which to base advice on young children’s fish consumption;
  • Suggestions for improving the clarity and utility of the advice; and
  • How to integrate local advisories about fish from local streams, rivers, and lakes.

FDA and EPA intend to seek the input of FDA’s Advisory Committee on Risk Communication and may hold public meetings on the draft updated advice.  The comment period will close 30 days after the last transcript from these meetings becomes available.

FDA Restricts Nutrient Content Claims for Omega-3s

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a final rule restricting the nutrient content claims that may be made for omega-3 fatty acids.  Specifically, FDA is prohibiting existing nutrient content claims for the two omega-3s found in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and is restricting nutrient content claims for alpha-linolenic acid (ALA), the omega-3 found in flaxseed, nuts, and certain other plant foods.

FDA has authorized several nutrient content claims for EPA, DHA, and ALA.  These nutrient content claims were authorized under a special provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 403(r)(2)(G) (21 U.S.C. § 343(r)(2)(G)).  Because this provision was added by the Food and Drug Administration Modernization Act of 1997 (FDAMA), such claims are sometimes referred to as “FDAMA claims.”  A listing of FDA’s FDAMA nutrient content claims and health claims can be found here.

Under that provision, any person may submit a notification to FDA that it intends to make a nutrient content claim based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or human nutrition research or the National Academy of Sciences.  If the notification is submitted at least 120 days before introduction of the product bearing the claim into interstate commerce, the claim is authorized and may be made unless: (a) FDA informs the notifier during the 120-day period that required information is missing from its notification; (b) FDA issues a regulation prohibiting or modifying the claim; (c) FDA issues a regulation finding that the statutory requirements have not been satisfied; or (d) a federal district court determines the statutory requirements have not been satisfied.  FDA refers to this as an “alternative, expedited notification process to allow certain nutrient content claims to be made without going through the petition process.”

FDA received three separate notifications in 2004 and 2005 for nutrient content claims about EPA, DHA, and ALA.  All three were based on authoritative statements made in a report of the Institute of Medicine, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids.  When FDA did not object, the nutrient content claims set forth in these notifications were authorized and have been used in labeling for a variety of food products.

Today’s final rule is the first time that FDA has issued a regulation prohibiting a FDAMA nutrient content claim or health claim.  It therefore offers insight into how FDA views such claims.

First, FDA says that the authoritative statement that serves as the basis for a FDAMA nutrient content claim must identify a “single, precise nutrient level” that could serve as the basis for a Daily Value for use in nutrition labeling.  Under FD&C Act Section 403(r)(2)(G)(i), a FDAMA nutrient content claim must be based on an authoritative statement “which identifies the nutrient level to which the claim refers.”  According to FDA, the term “nutrient level” in the statute refers to a reference value “that reflects a recommended or defined intake level that could serve as the basis for setting a DV” for use in nutrition labeling.  Because the authoritative statements relied on by the notifications for the EPA and DHA nutrient content claims did not identify a precise level of EPA or DHA,  they do not satisfy this statutory requirement and cannot be the basis for nutrient content claims about EPA and DHA.  FDA also notes that the authoritative statements relied on do not appear to be authoritative statements at all, because they do not “appear explicitly as findings, conclusions, or recommendations” and therefore do not meet the National Research Council Governing Board’s definition of “authoritative statement.”

Second, FDA states that the single nutrient level that serves as the basis for a FDAMA nutrient content claim must be determined using the same approach FDA has used to determine Daily Values (DVs) for other nutrients, i.e., the “population-coverage approach.”  Under the population-coverage approach, the reference value for a nutrient is set at a level sufficient to cover all gender and age groups.  Because some of the nutrient content claims authorized for ALA (i.e., those based on a Daily Value of 1.3 g) used a “population-weighted approach,” those claims are prohibited.  According to FDA, using two different approaches to set a reference value for the same nutrient would result in inconsistent and conflicting nutrient content claims on foods, which would confuse consumers and make meaningful product-to-product comparisons impossible.

Although the agency is prohibiting nutrient content claims about EPA and DHA, food manufacturers may continue to make the following labeling claims about EPA and DHA omega-3 fatty acids:

  • The qualified health claim authorized by FDA about EPA and DHA and reduced risk of heart disease.  That claim reads:

“Supportive but not conclusive research shows that consumption of
EPA and DHA omega-3 fatty acids may reduce the risk of CHD.  One
serving of [name of food] provides __ gram(s) of EPA and DHA
omega-3 fatty acids.  [See nutrition information for total fat, saturated
fat, and cholesterol content].”

The criteria a food must meet to be eligible for this claim can be found here.

  • A permissible structure/function claim about EPA and/or DHA (e.g., “EPA and DHA omega-3s help maintain a healthy circulatory system”).
  • A factual statement about the amount or percentage of EPA and/or DHA (or of omega-3 fatty acids generally) in the food, provided such statement is truthful and not misleading and does not in any way implicitly characterize the level of EPA or DHA in the food (e.g., “Contains __ mg of EPA and DHA omega-3s per serving,” “__ mg of omega-3s”).
  • For dietary supplements, a simple percentage claim (e.g., “40% EPA and DHA omega-3 fatty acids”) or comparative percentage claim (e.g., “four times the EPA and DHA omega-3s per capsule (80 mg) as in 100 mg of menhaden oil (20 mg)”).

FDA also notes that interested persons are free to submit petitions for nutrient content claims for EPA and DHA if they believe the scientific evidence warrants them.

As a result of the final rule, only the following nutrient content claims about ALA will be permitted:

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FDA says it is expressing no opinion as to whether the above ALA nutrient content claims are supported by an authoritative statement that meets the statutory requirements.

The final rule will become effective on January 1, 2016, which is the uniform compliance date for food labeling rules issued between January 1, 2013 and December 31, 2014.  The rule finalizes, without change, a proposed rule that was published in November 2007.

Can EPA Regulate Animal Operations as Landfills? 1

By John G. Dillard

Four Washington State dairies are the targets of environmental activists in lawsuits that could have far-reaching consequences for animal agriculture in the United States. In these cases, the environmentalists assert that the dairies’ manure storage and application practices violate the Resource Conservation and Recovery Act (RCRA), the federal statute that regulates the disposal of solid and hazardous waste. The crux of the environmentalists’ argument is that manure is a “solid waste” under RCRA if it is not strictly used as a fertilizer applied at agronomic nutrient uptake rates.

The Case

The plaintiffs, Community Association for the Restoration of the Environment (“CARE”) and Center for Food Safety (“CFS”), brought suit against the dairies under RCRA’s “citizen suit” provision. RCRA is generally enforced in the context of sanitary landfills and industrial waste disposal, not agricultural operations. However, the plaintiffs allege that the dairies are violating Section 7002(a) of RCRA by storing, handling, and disposing of manure in a manner that endangers health and the environment. Furthermore, the plaintiffs contend that the dairies’ manure handling activities amount to “open dumping” of solid waste, which violates Section 4005(a) of RCRA.

In additional to seeking recovery of their attorneys’ fees, CARE and CFS are seeking an injunction that would require the dairies to undertake several remedial and preventive actions. Some of these actions include installing synthetic liners in all existing storage lagoons, undertaking an extensive soil and water quality monitoring program, funding independent study to develop a remediation plan, and providing an alternative drinking water source for neighbors within a three-mile radius of the dairies.

Is Manure a Solid Waste?

Manure is generally not considered a “solid waste” for the purposes of RCRA. RCRA defines solid waste as “garbage, refuse . . . and other discarded materials” resulting from commercial and community activities. Manure is not typically discarded, but is instead a useful by-product of animal agriculture. In fact, EPA regulations specifically exempt manure from RCRA if it is “returned to the soil as fertilizers and soil conditioners.”

While recognizing the exemption for manure as a fertilizer, the plaintiffs alleged that manure is a solid waste if it is applied at levels beyond agronomic uptake rates or leaks into groundwater. In other words, the plaintiffs’ case rests on the theory that any manure that is not strictly used as a fertilizer is “discarded” and thus, a solid waste. Using this theory, the plaintiffs alleged that the dairies violated RCRA due to excessive application of manure to agricultural fields that resulted in runoff or leaching into the soil. Furthermore, the plaintiffs alleged that millions of gallons of liquid manure leaked out of the dairies’ lagoons and entered groundwater supplies.

This is not the first time a case has been litigated under this theory. In 2006, EPA sought to hold a swine operation liable under RCRA on the basis that manure applied in excess of agronomic uptake rates was a “solid waste” for RCRA purposes. However, EPA and the swine producer entered into a consent decree, which avoided establishing precedent on the matter. In a separate matter, Oklahoma v. Tyson Foods, Inc., the state of Oklahoma applied the same theory to poultry litter. In that case, the court held that manure applied as a useful fertilizer did not transform into solid waste simply because its entire contents were not absorbed by crops as nutrients. 2010 WL 653032 at *10.

Plaintiffs Have Cleared a Hurdle

The dairies sought to have the cases dismissed on the basis that manure intended for use as fertilizer is not transformed into solid waste in the event it is over-applied to fields or leaked from lagoons. However, in a setback to the dairies, the court rejected this argument. The court did acknowledge that Congress did not intend for manure that is applied as fertilizer to be regulated as a solid waste under RCRA. However, the Court held that it was “untenable” that manure could never transform into solid waste through unintentional excess application or leaking from lagoons.

By surviving the motion to dismiss, the plaintiffs cleared a substantial legal hurdle. The case now rests on whether the plaintiffs can demonstrate that the dairies’ manure storage and application activities actually led to manure runoff and leaching as well as leakage into the groundwater. Whether the facts of the case match the plaintiffs’ claims remains to be seen. For instance, USDA’s Natural Resources Conservation Service was highly critical of EPA’s methodology and conclusions in a study of the dairies’ impact on drinking water; the plaintiffs rely, in part, on this study for their own claims.

Parallel EPA Enforcement

These Washington state dairies are also the subjects of EPA enforcement actions under the Safe Drinking Water Act. EPA targeted the dairies because it believed they were the cause of elevated nitrate levels in drinking water in the vicinity of the operations. EPA initially served Notices of Violation to five Yakima Valley dairies. Rather than face enforcement, one dairy decided to cease operations and sell off its herd. The other four entered into onerous consent decrees, which require the dairies to provide alternative drinking water sources for neighbors within a one-mile radius, install multiple monitoring wells on the property, and conduct a comprehensive assessment that identifies ways to reduce or minimize the impact of the dairies on surrounding water quality.

Implications for Agriculture

Activists often seek to bring ordinary agricultural practices under the purview of RCRA. For instance, in Safe Air for Everyone v. Meyer, several of my OFW Law colleagues represented a group of Idaho bluegrass farmers in another RCRA citizen suit brought by activists over the practice of “open burning” fields, which promotes regeneration of bluegrass and maintains yields after seeds are harvested. In Meyer, the Ninth Circuit held that an agricultural “waste,” such as grass residue, is not a solid waste under RCRA if the generators of the residue (farmers) reuse it  in a continuous system that improves crop yields and is in accordance with established farming practices.

The Washington dairy cases could have major implications for livestock, dairy and poultry operations in the United States. Manure is a valuable by-product and a critical component for ecological and economic sustainability in animal farming operations. Animal agriculture is accustomed to regulation under the Clean Water Act. However, shoehorning livestock, dairy and poultry operations into RCRA, a statute intended to regulate waste storage and sanitary landfills, has the potential to create confusion and possibly duplicative regulations.

I will be following this case and will provide updates as necessary.

Environmentalists, Glyphosate and Butterflies

By John G. Dillard

The Natural Resource Defense Council (NRDC) has petitioned EPA to restrict the use of glyphosate herbicide to protect the dwindling population of the monarch butterfly. The petition states that the rapid adoption of glyphosate-resistant (Roundup Ready®) corn and soybeans in the Midwest has depleted the milkweed “community,” which serves as the exclusive food source for monarch butterfly larvae along the route of its annual migration from Canada to Mexico.

NRDC petitioned EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA requires EPA to register each pesticide used in the U.S. and set parameters for the pesticide’s use, such as target species, labeling requirements, and restrictions on use. Each pesticide must undergo a re-registration process every 15 years. The current glyphosate re-registration process will be completed in 2015; however, NRDC has requested EPA take action to restrict the use of glyphosate prior to the scheduled completion of the re-registration process.

Under FIFRA, EPA can register a pesticide only if it first determines that the pesticide “will perform its intended function without unreasonable adverse effects on the environment.” FIFRA defines an unreasonable adverse effect on the environment to include “any unreasonable risk to . . . the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” In its petition, NRDC argues that the loss of milkweed communities brought about by increased glyphosate use has brought about unreasonable adverse effects on the environment because it has decreased monarch butterfly habitat.

Read the rest of this post on John Dillard’s AgWeb.com blog – Ag in the Courtroom.