Breaking News - USTR Releases Text of Trans-Pacific Partnership (“TPP”) Agreement
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP
In a notice to be published in the Federal Register on November 9, 2015, the President announced that he has notified the Congress of his intention to sign the recently negotiated Trans-Pacific Partnership Agreement (“TPP”). This follows closely on the heels of a November 5thpublic release of a “Subject to Legal Review” text of the TPP.
The TPP is an unprecedented free trade agreement reached by negotiators of twelve countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States and Vietnam) after over five years of negotiations. The TPP, which impacts approximately 40% of global trade, brings with it the elimination or reduction of duties on goods from the member countries that satisfy specified rules of origin and other technical requirements. The TPP follows a NAFTA-like approach with special rules applying to certain sectors, including textiles and automotive.
The TPP is subject to Congressional review under “fast track” procedures which, subject to certain conditions, limits Congress to an up or down vote (i.e., not subject to amendment). The fast track legislation, however, provides for a number of required steps before implementation.
Such steps include (among others): notification by the President to Congress and the public of his intent to sign the Agreement at least 90 days in advance of signature; making the Agreement text publicly available at least 60 days before Presidential signature; submission to Congress of a list of required U.S. legal changes within 60 days after entering into the Agreement; submission to Congress of a copy of the final legal text of the agreement at least 30 days before submitting the implementing legislation; and passage by Congress of the implementing legislation into law. The Presidential announcement has started the 90-day clock on the first step forward.
For more information, please visit Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP
FSMA Final Rule for Preventive Controls for Human Food
U.S. Food & Drug Administration
View the Final Rule Contents in Docket Folder FDA-2011-N-0920
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016.
This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders. This outreach began before the rule was proposed in January 2013.
In response to input received during the comment period and during hundreds of engagements that included public meetings, webinars, listening sessions, and visits to farms and food facilities across the country, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions were designed to make the originally proposed rule more practical, flexible, and effective for industry, while still advancing the FDA’s food safety goals.
The final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms— which are exempt from these regulations— has significantly changed to reflect modern farming practices.
Because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term “natural,” the agency is asking the public to provide information and comments on the use of this term in the labeling of human food products.
The FDA is taking this action in part because it received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling and one Citizen Petition asking that the agency prohibit the term “natural” on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.”
Although the FDA has not engaged in rulemaking to establish a formal definition for the term “natural,” we do have a longstanding policy concerning the use of “natural” in human food labeling. The FDA has considered the term “natural” to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term “natural” should describe any nutritional or other health benefit.
Specifically, the FDA asks for information and public comment on questions such as:
- Whether it is appropriate to define the term “natural,”
- If so, how the agency should define “natural,” and
- How the agency should determine appropriate use of the term on food labels.
The FDA is accepting public comments from November 12, 2015 through February 10, 2016.
Corruption and Illegal Trade in Wildlife
CITES
Corruption is “an insidious plague” that is present in the wildlife sector just as it is in other sectors, indeed in virtually any form of human activity.
A clear message of the determination of the international community to work to prevent and combat corruption was sent with the adoption by the United Nations General Assembly (UNGA) of the UN Convention Against Corruption in 2003 and its entry into force in 2005.
In the case of illegal trade in wildlife, corruption is often an integral component – and the impacts of this corruption are not only affecting people, our institutions, and quality of life, but they are also driving certain species of wild animals and plants to extinction, including some of the world’s most charismatic species such as elephants and rhinos.
CITES regulates international trade in CITES-listed animals and plants, and this involves addressing both legal and illegal trade. For domestic or international trade in wildlife to be described as illegal or as ‘illicit wildlife trafficking’, which is often used to refer to illegal trade, it must contravene either domestic or international law (or both).2
Articles II and VIII of CITES oblige States that are Party to the Convention not to trade in listed species other than in accordance with the Convention, to take appropriate measures to enforce the Convention and to prohibit trade in violation thereof, including measures to penalize such trade.
The Convention regulates commercial and non-commercial international trade in over 35,000 species of animals and plants, including their parts and derivatives, which often find their way into medicines, food, building materials, cosmetics, clothes, furniture and many other commodities.
For certain species, commercial international trade in wild taken specimens is prohibited. These species are included in Appendix I of the Convention and they are categorized as threatened with extinction. This prohibition, for example, includes commercial trade in elephant ivory, rhino horn, great apes, marine turtles and tigers.
For other species commercial international trade is subject to strict regulation to be sure it is legal, sustainable and traceable. These species are included in Appendix II of the Convention and they are categorized as not yet necessarily threatened with extinction but they could become so if trade is not strictly regulated. This regulated legal trade includes commercial trade in approximately 96% of CITES-listed animal and plant species, such as crocodile and python skins, the meat of the queen conch, the wool of the vicuña, and the bark of the African cherry tree.
When a State does decide to allow trade in a CITES Appendix II listed species the Convention sets out three requirements that must be met, namely the need to:
- make a legal acquisition finding – being a certification that the specimens have been taken in accordance with national law;
- make a non-detriment finding – being a science-based biological sustainability finding that takes account of the role of the species in its ecosystem; and
- issue the appropriate permit/certificate and report the trade – being the formal authorization and report of the trade transaction to the CITES Secretariat.
Consequently, illegal trade, or ‘illicit wildlife trafficking’, under CITES includes violating the prohibition against trading commercially in wild-taken specimens of Appendix I listed species, or trading commercially in any specimens of Appendix II or III listed species without obtaining, or following the conditions within, the necessary permits or certificates. The illegal possession of specimens illegally imported or otherwise acquired is also included.
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The text of CITES itself does not expressly mention corruption, but the need to fight corruption in combating illegal trade in wildlife has been acknowledged in many ways, including by a CITES Resolution on compliance and enforcement, in which the Conference of the Parties to CITES recommended that “Parties that are not yet signatories to, or have not yet ratified, the UN Convention on Transnational Organized Crime and the UN Convention Against Corruption consider doing so”.
Recent high-level political recognition of the links between corruption and illegal trade in wildlife was captured in the first dedicated UNGA resolution on Tackling Illicit Trafficking in Wildlife5, adopted in July, which “Calls upon Member States to prohibit, prevent and counter any form of corruption that facilitates illicit trafficking in wildlife and wildlife products.” This ground breaking resolution also notes the important role of CITES and the UN Conventions against Transnational Organized Crime and Corruption, reinforcing the synergies between these three legally binding instruments.
Further, the Sustainable Development Goals (SDGs)6, adopted by the UNGA in September of this year, specifically address illegal trade in wildlife through two Targets under Goal 15 and a Target under Goal 16 specifically addresses reducing bribery and corruption in all their forms.
In 2012, the CITES Secretariat contributed to a UNODC publication on the environmental impacts of corruption titled Corruption, Environment and the United Nations Convention against Corruption and today’s event presents a very important opportunity to specifically focus on wildlife. In fact, today’s event is the first time in the history of the UN Convention Against Corruption that a high-level event has been convened to specifically address corruption and illegal trade in wildlife. And for that I would like to extend our sincere gratitude to UNODC Executive Director Yury Fedotov, who has championed this cause since we first met here in Saint Petersburg at the Global Tiger Summit in 2010.
The impacts of illegal trade in wildlife are deep and multifaceted8 and the fight against it is inextricably linked to the fight against corruption. And CITES cannot operate in isolation from the wider system – it is and must be an integral part of it.
International and national anti-corruption laws, institutions and efforts have the scope to address violations linked to illegal trade in wildlife. It is therefore crucial to ensure that combating corruption as it affects trade in wildlife and CITES implementation is built into other relevant conventions, national laws, institutions and programmes, which is why today’s event is so important.
The impact that overall anti-corruption measures can have on combating illegal trade in wildlife is evident from the on-going impact of the Chinese Government’s far-reaching campaign against corruption on the demand for, and illegal trade in, wildlife and their products. The anti-corruption and anti-extravagance campaign, while not specifically targeting illegal wildlife trade, has played a significant role in reducing the demand for illegal wildlife products. For example, ivory carvings and ivory tusks, among others, have often been used as gifts for bribery in China and this national campaign is clearly serving to drive down demand for illegally traded ivory.
And over the past five years CITES has, together with many partners including UNODC, successfully championed the need to treat wildlife crimes involving organized criminal groups as a “serious crime” as defined in the UN Convention Against Transnational Organized Crime. This collective effort has served to highlight the deep interaction and interconnectivity between CITES and the UN Convention against Transnational Organized Crime.
The UNGA Resolution, as well as the Crime Congress Doha Declaration10, decisions taken under CITES and the UN Commission on Crime Prevention and Criminal Justice, amongst others, have all highlighted the synergies between CITES and both UN Conventions Against Transnational Organized Crime and Corruption.
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CBP Scores Nearly $17k in Counterfeit Soccer Club Apparel
U.S. Customs & Border Protection
STERLING, Va. – U.S. Customs and Border Protection (CBP) scored big against trademark theft after seizing 5,383 pieces of counterfeit soccer apparel near Washington Dulles International Airport on November 2.
The haul included jersey tops and shorts that violated the intellectual property rights (IPR) of many well-known European “football” clubs, such as Arsenal, Barcelona, Manchester United, and Real Madrid.
If genuine, the soccer apparel would have an estimated manufacturer’s suggested retail price (MSRP) of $16,791.
“Soccer is one of the most popular sports around the world, and these clubs possess valuable intellectual property rights. It’s no surprise that some people will do anything to capitalize on the sport’s popularity, even if that includes resorting to theft of a trademark holder’s rights and revenues,” said Wayne Biondi, CBP Port Director for the Port of Washington Dulles. “Protecting intellectual property rights remains a Customs and Border Protection trade enforcement priority, and a mission that we take very seriously.”
The first shipment arrived on October 14. CBP detained the shipment to determine the apparel’s authenticity, then completed the seizure on November 2. That day, CBP encountered and seized a second shipment of counterfeit soccer apparel destined for the same consignee.
The apparel represented Arsenal, Barcelona, Brazil, Bayern Munchen, Borussia Dortmund, Chelsea, Juventus, Liverpool, Manchester City, Manchester United, Paris Saint-Germain, Real Madrid, and Tottenham Hotspur football clubs.
Trade in counterfeit and pirated goods threatens the competitiveness of America’s businesses, the livelihoods of U.S. workers, and the health and safety of consumers. To protect American businesses and consumer from the harms caused by IPR theft, CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR violative goods.
During fiscal year 2014, CBP made more than 23,000 seizures of counterfeit goods, which, if genuine, would have an estimated total MSRP value of more than $1.2 billion.
CBP, HSI Warn Consumers Ahead of Holiday Shopping Season
U.S. Customs & Border Protection
Fake, unsafe products may not be worth the savings
HOUSTON – U. S. Customs and Border Protection and Homeland Security Investigations officials warn shoppers Nov. 6 to be wary when looking for holiday deals.
Black Friday and Cyber Monday have traditionally been big shopping days for consumers.
“Every year, criminal organizations prey on unsuspecting consumers who are looking for great bargains during the holiday day season,” said Houston CBP Seaport Assistant Port Director Leslie Luczkowski. “Black Friday and Cyber Monday shoppers who are searching for that great gift should also be aware that some of those great finds may not meet their expectation and that those items are actually funding well-organized criminal organizations.”
Protecting intellectual property rights is a priority trade issue. CBP has developed a multi-layered strategic approach to IPR enforcement which includes intelligence and information sharing as well as leveraging technology such as e-Recordation, a web-based tool CBP uses to access trademarks and copyrights.
CBP protects businesses and consumers by seizing products that infringe trademarks, copyrights, and patents. In fiscal year 2014, there were 23,140 intellectual property rights seizures with a manufacturer’s suggested retail value of $1.2 billion with goods from China accounting for 63% of the total manufacturer’s suggested retail value for all IPR seizures. Wearing apparel was the top seized commodity in fiscal year 2014.
Consumers who suspect that a business or internet site is trafficking in counterfeit goods, should call 1-866-477-2060 or email
IPRCenter@dhs.gov