• Period of Admission and Extensions of Stay for Representatives of Foreign Information Media Seeking to Enter the United States
  • This rule amends Department of Homeland Security (DHS) regulations to better facilitate the U.S. Government’s ability to achieve greater reciprocity between the United States and the People’s Republic of China (PRC) relative to the treatment of representatives of foreign information media of the respective countries seeking entry into the other country.
  • For entry into the United States, such foreign nationals would seek to be admitted in I nonimmigrant status as bona fide representatives of foreign information media. Currently, foreign nationals who present a passport issued by the PRC, with the exception of Hong Kong Special Administrative Region (SAR) or Macau SAR passport holders, may be admitted in or otherwise granted I nonimmigrant status until the activities or assignments consistent with the I classification are completed, not to exceed 90 days.
  • This rule amends the DHS regulations to remove the set period of stay of up to 90 days and to allow the Secretary of Homeland Security (Secretary) to determine the maximum period of stay, no longer than one year, for PRC I visa holders, taking into account certain factors.
  • This rule also announces the Secretary has determined the maximum period of stay for which a noncitizen who presents a passport issued by the PRC (other than a Hong Kong SAR passport or a Macau SAR passport) may be admitted in or otherwise granted I nonimmigrant status is one year
  • This rule was effective on October 13, 2022.
• Arrival Restrictions Applicable to Flights Carrying Persons Who Have Recently Traveled From or Were Otherwise Present Within Uganda
  • This document announces the decision of the Secretary of the Department of Homeland Security (DHS) to direct all flights to the United States carrying persons who have recently traveled from, or were otherwise present within, Uganda to arrive at one of the United States airports where the United States government is focusing public health resources to implement enhanced public health measures.
  • For purposes of this document, a person has recently traveled from Uganda if that person departed from, or was otherwise present within, Uganda within 21 days of the date of the person’s entry or attempted entry into the United States.
  • Also, for purposes of this document, crew and flights carrying only cargo (i.e., no passengers or non-crew), are excluded from the measures herein.
  • The arrival restrictions apply to flights departing after 11:59 p.m. Eastern Daylight Time on October 10, 2022. Arrival restrictions continue until cancelled or modified by the Secretary of DHS and notice of such cancellation or modification is published in the Federal Register.
• Proposes Revocation of Two Ruling Letters and Proposed Revocation of Treatment Relating to the Tariff Classification of Pan Masala Betel Nut Food Product
  • In NY 830068 and DD H890859, CBP classified the pan masala betel nut food product in heading 2106, HTSUS, specifically in subheading 2106.90.6099, HTSUS Annotated (HTSUSA) (currently subheading 2106.90.99, HTSUS, under the 2022 HTSUS), which provides for “Food preparations not elsewhere specified or include Other: Other: Other: Other.”
  • CBP has reviewed both NY 830068 and DD H890859 and has determined the ruling letters to be in error.
  • It is now CBP’s position that pan masala betel nut food product is properly classified, in heading 2008, HTSUS, specifically in subheading 2008.19.9090, HTSUSA, which provides for “Fruit, nuts and other edible parts of plants, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included: Other, including mixtures: Other, including mixtures: Other: Other.”
• Nucor Corporation v. United States
  • Plaintiff Nucor Corporation (“Nucor”) challenges the U.S. Department of Commerce’s (“Commerce” or “the agency”) final results in the 2018 administrative review of the countervailing duty (“CVD”) order on certain carbon and alloy steel cut-to-length plate (“CTL plate”) from the Republic of Korea (“Korea”).
  • Nucor challenges Commerce’s determination not to initiate an investigation into the alleged provision of off-peak electricity for less than adequate remuneration (sometimes referred to as “LTAR”) and Commerce’s determination that mandatory respondent POSCO and its affiliate POSCO Plantec (“Plantec”) do not meet the requirements necessary to find a cross-owned input supplier relationship.
  • The Court ordered the following:
    • 1. That Commerce’s Final Results are sustained in part and remanded in part.
    • 2. On remand, Commerce shall reconsider or further explain its determination not to investigate the alleged off-peak sale of electricity for less than adequate remuneration.
    • 3. On remand, Commerce shall reconsider or further explain its determination not to treat Plantec as a cross-owned input supplier in connection with the supply of scrap.
    • 4. Commerce shall file its remand redetermination on or before January 3, 2023.
    • 5. Subsequent proceedings shall be governed by US-CIT Rule 56.2(h); if, however Commerce determines to investigate whether off-peak electricity is provided for less than adequate remuneration, the Parties may instead file a joint status report addressing the timing of any necessary further administrative proceedings.
    • 6. Any comments or responsive comments must not exceed 4,000 words.

Importers not adequately auditing their supply chains for use of forced labor are at risk of administrative and criminal enforcement. Imported merchandise produced with forced labor is subject to the Department of Homeland Security (DHS) enforcement. Such enforcement includes U.S. Customs and Border Protection’s (CBP) right to detain, exclude, and/or seize imported goods and Homeland Security Investigation’s potential criminal investigation. China is not only the United States’ number one trading partner but also happens to be the world’s biggest forced labor violator.

Background

In May 2014, China initiated the campaign  “Strike Hard against Violent Extremism”, claiming to combat the “three evils” of “ethnic separatism, religious extremism, and violent terrorism.” The Chinese Communist Party (CCP) used this justification to impose restrictions on members of the ethnic minority communities of the Xinjiang Uighur Autonomous Region. These efforts dramatically increased in August 2016, when Communist Party Secretary Chen Quanguo, known as the architect of China’s Muslim camps, assumed leadership of Xinjiang. According to Human Rights Watch:

• Xinjiang authorities conduct a compulsory mass collection of biometric data, such as voice samples and DNA, and use artificial intelligence and big data to identify, profile, and track everyone in Xinjiang. The authorities have envisioned these systems as a series of “filters,” picking out people with certain behavior or characteristics that they believe indicate a threat to the Communist Party’s rule in Xinjiang.

This dystopian system has progressed into the rapid establishment of “re-education” camps. In these camps, guards force the Muslim detainees to break Halal, mandating they drink alcohol, and only serving pork at meals. China reportedly takes DNA samples from Uighur camp prisoners and uses them as human test subjects in gang rapes and medical experiments.

Since 2014, the situation in Xinjiang, China has progressed from the simple collecting of Biometric data from a subsect of the population, to full-blown extrajudicial internment, re-education camps, forced sterilization, and organ harvesting. According to a 2015 report, China’s illegal organ transplant industry is valued at over $1 billion each year. The labor from these camps is the life-blood of the campaign. The interred individuals are essentially paying for their treatment in that they generate revenue that the government subsequently pumps back into the system of abuse.

Dr. Adrian Zenz, a Senior Fellow in China Studies at the Victims of Communism Memorial Foundation in Washington has authored various books regarding China’s policies towards ethnic minorities, and has played a leading role in the analysis of leaked Chinese government documents, including the “China Cables” and the “Karakax List.” Dr. Zenz has been integral in enlightening the world on the situation in China. In a recent Washington International Trade Association (WITA) webinar regarding the scope and scale of forced labor in Xinjiang, Dr. Zenz stated that the current crisis is worse than anything we have witnessed since the Holocaust. According to Dr. Zenz, whereas the Nazis sent Jews to concentration camps and death camps; the Chinese send Uighurs to concentration camps, re-education camps, or demoralization camps, instead. Despite the differences, the systematic nature and end goal of the Chinese government’s policy towards the Uighurs is emblematic of the Nazi’s policy towards the Jew’s: forced assimilation and or eradication of the culture and prevention of its proliferation.

• “[T]he Chinese government has placed vast numbers of Turkic minorities into internment camps, which it refers to as “reeducation camps,”… it claimed that these supposed students would gradually be released into work placements. Data such as this supports this claim, but not in the way that the government is trying to sell it. Rather, it is part of a rapidly growing set of evidence for how Beijing’s long-term strategy to subdue its northwestern minorities is predicated upon a perverse and intrusive combination of coercive labor, intergenerational separation, and complete social control.” Dr. Zenz, Xinjiang’s New Slavery

Dr. Zenz explicitly stated that while the Chinese are not (yet) committing mass extermination, the abuses against its Uighur population definitively constitutes a genocide. From religious oppression, to forced sterilization, to internment, to forced labor or slavery, to re-education — the CCP has been deliberate in its attempt to eliminate the Uighur ethnicity. Dr. Zenz articulated that the Chinese are engaging in a slow-rolling genocide, also known as an “ethnocide”.

Despite the overwhelming evidence supporting claims of systematic abuses such as coercive population control through forced abortion, forced sterilization, and involuntary implantation of birth control;  Chinese officials continue to defend the supposedly legitimate purpose of these camps.

Combating Chinese Concentration Camps – Forced labor Angle

In its 2019 Annual Report, the Congressional-Executive Commission on China found that products reportedly produced with forced labor by current and former mass internment camp detainees included textiles, electronics, food products, shoes, tea, and handicrafts.

Since the publication of the September 2018 Human Rights Watch report, news of these concentration camps started garnering international recognition. Congress began introducing bills, like the UIGHUR Act of 2019, which aimed at addressing the “human rights violations and abuses, including gross violations of human rights, by the People’s Republic of China’s mass surveillance and internment of [Millions of] Uighurs and other predominantly Turkic Muslim ethnic minorities in China’s Xinjiang Uighur Autonomous Region.”.

These efforts increased when President Trump signed the Uyghur Human Rights Policy Act of 2020 into law on June 17, 2020. Under the UHRA, the President may impose property-blocking or visa-blocking sanctions on the identified foreign individuals and entities responsible for human rights abuses in China’s Xinjiang Uyghur Autonomous Region. The UHRPA also requires the Executive branch to periodically report to Congress a list identifying foreign individuals and entities responsible for such human rights abuses. Furthermore, although it has not yet been signed into law, bills such as the Uyghur Forced Labor Prevention Act, which was introduced on March 12, 2020, signify that Congress understands the gravity of the situation. Some of the key findings included in the Bill are as follows:

• There is a very high risk that many factories and other suppliers in the Xinjiang Uyghur Autonomous Region are exploiting forced labor, according to reports from researchers, media, and civil society groups. Audits to vet products and supply chains in the Xinjiang Uyghur Autonomous Region are not possible because of the extent to which forced labor has contaminated the regional economy, the mixing of involuntary labor with voluntary labor, the inability of witnesses to speak freely about working conditions given heavy government surveillance and coercion, and the strong incentive of government officials to conceal government-sponsored forced labor.
• In its June 2019 Trafficking in Persons Report, the Department of State found, Authorities offer subsidies incentivizing Chinese companies to open factories in close proximity to the internment camps, and local governments receive additional funds for each inmate forced to work in these sites at a fraction of minimum wage or without any compensation.
• According to public reports, companies that are or have been suspected of directly employing forced labor or sourcing from suppliers that are suspected of using forced labor include (among others):
  • Adidas,
  • Calvin Klein,
  • the Campbell Soup Company,
  • the Coca-Cola Company,
  • Costco,
  • Esprit,
  • H&M,
  • the Kraft Heinz Company,
  • Nike, Inc.,
  • Patagonia, Inc.,
  • Tommy Hilfiger.

Whether out of ignorance or neglect, American and European dollars have helped facilitate the use of forced labor, if not slavery; which pursuant to 19 U.S.C. 1307 is prohibited.

Active Measures

In line with sanctioning individuals and entities is the strategic use of Withhold Release Orders (WROs). A WRO directs CBP Officers at all ports of entry to withhold release of goods originating from a listed company or country.  These targeted sanctions have been especially effective at identifying certain nations, industries, and companies that employ forced labor in any way. CBP provides the public with a list of all WROs and the findings of the investigations. Right now, the majority of active WROs are focused on items produced in China. In fact, the majority of WROs the USTR implemented since 2016, are directed at China.  Below is a list of each WRO implemented against China since 2016:

Following the imposition of a WRO on hair products originating from the Lop County Meixin hair product company on June 17, 2020, CBP has implemented additional WROs on other industries in the region. The impositions of WROs against China saw a recent uptick on July 1, 2020 as a result of another seizure of hair products made in China. Following this seizure, CBP issued a Xinjiang Supply Chain Business Advisory, which highlights that the Federal Government recognizes the harsh repression and illicit practices of the Chinese regime, and cautions US stakeholders– businesses, individuals, academic institutions, research service providers, and investors – that continue to operate business with entities in Xinjiang.

Specifically, the advisory states that these companies

should be aware of reputational, economic, and, in certain instances, legal, risks associated with certain types of involvement with entities that engage in human rights abuses, which could include Withhold Release Orders (WROs), civil or criminal investigations, and export controls.

Xinjiang Cotton Ban

During the last week of the Trump Administration, on January 13, 2021, the United states issued a Region-Wide Withhold Release Order on Products Made by Slave Labor in Xinjiang Specifically, CBP imposed a WRO on all Cotton, Tomatoes and Downstream Products originating in the Xinjiang Uyghur Autonomous Region (XUAR). CBP issued the WRO after identifying various forced labor indicators including debt bondage, restriction of movement, isolation, intimidation and threats, withholding of wages, and abusive living and working conditions.

According to CBP, on December 2, 2020, CBP announced the issuance of a WRO on cotton and cotton products originating from the Xinjiang Production and Construction Corps, an economic and paramilitary organization subordinate to the Chinese Communist Party. The region-wide WRO is the fourth WRO that CBP has issued since the beginning of Fiscal Year 2021, and the second on products originating in Xinjiang. All WROs are publicly available and listed by country on CBP’s Forced Labor WROs and Findings webpage.

The decision to ban cotton products marks the most substantial action. Out of the estimated three million detained Uighurs, over 500,000 have been forced to work in cotton fields. Moreover, cotton from the Xinjiang region accounts for 85% of China’s cotton production, and more than 20% of the world’s cotton.

Biden on Forced Labor

The Biden Administration has committed to maintaining a strident approach towards China. On January 20, 2021 upon being sworn in as Secretary of State, Anthony Blinken stated:

On the Uighurs I think we’re very much in agreement. And the forcing of men, women and children into concentration camps, trying to, in effect, re-educate them to be adherents to the ideology of the Chinese Communist Party, all of that speaks to an effort to commit genocide.

Practitioner Tips

According to CBP, importers must exercise reasonable care and due diligence to ensure that forced labor is not included in any aspect of their supply chain. In order to effectively mitigate their risk, importers must understand the timely and costly detention process and know the importance of using CBP’s reasonable care checklist and implementing best practices. Additionally, importers should conduct a robust internal risk assessment, and audit their supply chain and import history. Further, importers should be aware of their ability to contest a WRO or argue for the release of detained shipments.

For more information regarding CBP’s current enforcement environment in targeting and combatting the use of forced labor, as well as top tips on how to avoid forced labor to in your supply chain— reference our Bloomberg Law article titled “U.S. Customs Targets Forced Labor” co-authored by Jennifer Diaz, and Denise Calle of Diaz Trade Law with support from Zachary Kaufman.

Conclusion

For assistance with importer due diligence in relation to forced labor requirements; or for assistance re-exporting your detained merchandise, in submitting documents to dispute the use of forced labor, or for assistance with the revocation request process, contact our Customs and International Law attorneys at info@diaztradelaw.com or 305-456-3830.

Methanol is a nondrinking type of alcohol (also known as wood alcohol and methyl alcohol) which is mostly used to create fuel, solvents and antifreeze. A colorless liquid, it is volatile, flammable, and unlike ethanol, poisonous for human consumption. Methanol is also used to produce a variety of other chemicals, including acetic acid.

–ChemicalSafteyFacts.org

Since the advent of the COVID-19 pandemic, roughly a year ago, the importation of hand sanitizers into the United States has increased dramatically. As the importation of hand sanitizers sky-rocketed, so did importations of toxic, or tainted products. In particular, there has been a concerning rise in the use of methanol to produce hand sanitizers in Mexico.

In order to combat this potential public health crisis, the FDA has issued multiple warning letters to hand sanitizer producers since July.  According to the FDA, however, analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s regulations, and more than 50% of samples were found to contain toxic ingredients at dangerous levels.

To further its effort in stopping violative products from entering the US, the FDA has now placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert. The import alert ensures that all shipments of imported hand sanitizer from Mexico are detained without physical examination (DWPE) upon entry into the U.S.  For tips on getting off the Import Alert (AKA the Black List) see “How to Get Off the FDA ‘Black List’.”

Although the FDA now has more authority to identify these products, it stated in the import alert that it “reminds manufacturers, distributors, repackagers, and importers they are responsible for the quality of their products and urge manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination”. In order to aid the public in this effort, the FDA published a guidance document, which outlines the FDA’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.

For more information on FDA Import Alerts or assistance in requesting to be removed from an Import Alert, contact us today at info@diaztradelaw.com or 305-456-3830.

What’s the National Organic Program?

Established by Congress and announced in 2000, the U.S. Department of Agriculture’s (“USDA”) National Organic Program (“NOP”) is a federal regulatory program which develops and enforces uniform national standards for organically-produced agricultural products sold in the United States. NOP operates as a public-private partnership which accredits third-party organizations to certify that farms and businesses meet the national organic standards. By enforcing its standards, NOP ensures a level playing field for producers while protecting consumer confidence in the integrity of the USDA organic seal.

How does NOP Enforcement Work?

The NOP’s Compliance & Enforcement Division (“C&E”) is involved in enforcement organic standards. C&E enforces rules by working with independent certifying agencies. Independent certifying agencies accredited by the USDA conduct periodic inspections or audits. If a certifying agency finds a violation, it can issue one of the following notices:

• Conditions for a new/continued certification (for minor issues)
• Notice of noncompliance
• Denial or proposed suspension of certification (for major non-compliances)
• Denial or proposed revocation of certification (for major non-compliances)

When a certifier proposes to suspend or revoke an operation’s organic certification, it must provide the operation with the right to request mediation. The goal of the mediation process is to engage in alternative dispute resolution to lead to a settlement agreement between the operator and the certifier. The certifier may accept or reject the mediation request.

NOP Penalties

Organic producers and distributors who violate national organic standards are subject to potentially severe civil and criminal penalties by the NOP. These penalties include civil fines, civil sanctions in the form of organic status suspensions or revocations, and even referral to law enforcement agencies for criminal proceedings.

For example, an organic producer or distributor’s mislabeling actions can result in penalties as high as $18,370 per violation. The term ‘violation’ here has been interpreted broadly and could sometimes mean per order or entry. In Re Xochitl, below, is an example of penalties compounding quickly because violations were interpreted by the number of orders/entries.

The following are NOP enforcement statistics in recent years:

Below are some case summaries explaining to NOP has penalized organic businesses for repeat noncompliance:

In Re Xochitl, Inc.

In a July 2017 USDA administrative law proceeding, In Re Xochitl, Inc., the respondent Xochitl, Inc. (“Xochitl”), a Texas corporation, was found by an independent accredited agency to be using nonorganic cottonseed oil in the production of corn chips sold as organic during an unannounced inspection. The independent agency issued Xochitl a Combined Notice of Noncompliance and Proposed Revocation, and Xochitl soon after admitted to the use of nonorganic cottonseed oil. Two months later, Xochitl filed a timely appeal of the Combined Notice of Noncompliance and Proposed Revocation with the USDA’s Agricultural Marketing Service (“AMS”) Administrator. A few months later, Xochitl signed a settlement agreement under which Xochitl agreed to withdraw its appeals, waive further proceedings, pay a civil penalty of $31,135, and have its organic certification suspended.

However, only three months after signing the settlement agreement, Xochitl was again investigated by AMS for selling products as organic without certification, which resulted in further violations. As a result of Xochitl’s further violations during suspension, the AMS Administrator upheld the independent agency’s revocation for five years and imposed a civil penalty of $1,826,000. The civil penalty amount was calculated by multiplying the $11,000 penalty (at the time) by 166 for each unique order of product sold by Xochitl as organic without certification during the suspension period. Ultimately, Xochitl only had to pay $475,000 and was even allowed to seek reinstatement in the organic program.

In Re Yorgo Foods, Inc.

Respondent, Yorgo Foods, Inc., produced agricultural products certified as organic. During an inspection by an accredited certifying agency, the agency found several (unpublished) noncompliances. This resulted in respondent being suspended (time period unspecified). Respondent asked to be reinstated, but NOP denied reinstatement. Respondent appealed NOP’s denial, but AMS Administrator denied appeal. Then, in a settlement agreement, respondent’s suspension was reduced to six months. However, a month later, the certifying agency found that respondent was selling organic products during suspension period. Because respondent had broken the settlement agreement, respondent and NOP signed a second settlement agreement in which respondent waived its right to an appeal and had to pay a civil penalty of $33,000.

However, even after signing the second settlement agreement, respondent was found to sell organic products while suspended in willful violation of the USDA. As a result, the AMS Administrator assessed a civil penalty of $880,000 with $540,000 held in abeyance, and respondent’s organic certification was suspended for three years. The remaining $340,000 was allowed to be paid in quarterly installments over a period of five years.

Settlement

Fortunately, NOP provides settlement opportunities to businesses who may have violated national organic standards but are willing to proactively cooperate to ensure past harms are mitigated and future violations are avoided. Typically, these settlements are executed as alternatives to administrative proceedings that may result in suspension or revocation of certification or accreditation, as well as civil penalties for the knowing sale of products in violation of the USDA organic regulations. Settlement always requires operations to comply with USDA organic regulations and, sometimes, includes specific compliance requirements and/or reduced civil penalties. NOP publishes details on some settlement proceedings on its website.

NOP Resources

The NOP offers helpful resources for the benefit of organic producers, distributors, and consumers. These resources help ensure that organic producers and distributors are proactive about their NOP compliance. These resources include:

• Organic Integrity Database
  • NOP’s Organic Integrity Database lets interested parties and the public alike research the organic status of organic farms and businesses. These listings are provided to NOP from accredited certifying agents.

• Organic Integrity Learning Center
  • Through its Organic Integrity Learning Center, NOP provides a wide range of free training and outreach materials for organic farms, businesses, and organic certification agencies. The Learning Center supports the professional development and continuing education of professionals working to protect organic integrity including certifiers, inspectors, reviewers and compliance specialists in organic businesses. Courses include

• National Organic Program Handbook
  • NOP’s handbook provides those who own, manage, or certify organic operations with guidance and instructions that can assist them in complying with the USDA organic regulations. Although the handbook is non-binding guidance, it provides critical insight into NOP’s procedures and expectations of industry.

Contact Us

Diaz Trade Law has assisted clients with understanding national organic standards, developing corrective action plans, and navigating settlement discussions with NOP. If you’re an organic producer or distributor and seek to build a proactive organic compliance program or successfully mitigate organic standards violations, reach out to us at 305-456-3830 or info@diaztradelaw.com.

National Space Policy Unveiled

On December 9, 2020, the White House released the National Space Policy of the United States of America. Among other objectives, the policy seeks to drive U.S. leadership in space commerce by encouraging the cultivation of U.S. industrial capacity in space innovation.

The new policy seeks to develop and protect the U.S. space industrial base by committing to:

• Strengthen U.S. technological leadership in space-related technology
• Enhance capabilities for assured access to space
• Safeguard space components of critical infrastructure
• Maintain and enhance space-based position, navigation, and timing systems
• Develop and retain space professionals
• Improve space system development and procurement
• Strengthen interagency and commercial partnerships

Commerce Department Secretary Wilbur Ross said, “This new National Space Policy reflects the emergence of space commerce as a driving force for positive change in our economic and national security, contributing to America’s leadership in commercial space. The policy sets the stage for American businesses to thrive domestically and compete internationally as the global space economy grows into a trillion dollar market over the next two decades.”

Speaking at the National Space Council in Cape Canaveral, Florida, Vice President Mike Pence discussed the threats posed by China and Russia to U.S. strategic interests in space:

“…China and Russia are continuing to develop space weaponry.  Russia demonstrated a space-based anti-satellite weapon earlier this year.  China is developing a new manned space station, and its robotic spacecraft will return samples from the Moon in just a matter of weeks. In fact, China is increasingly emerging as a serious competitor in space, just as they are in other areas of the global economy and to the strategic interest of the United States.”

Vice-President Pence’s announcement coincided with the U.S. Space Force (“USSF”) announcing on its one-year anniversary that it has decided a moniker for U.S. military service members serving in that new branch: guardians. In a press release, the USSF said: “The opportunity to name a force is a momentous responsibility. Guardians is a name with a long history in space operations, tracing back to the original command motto of Air Force Space Command in 1983, ‘Guardians of the High Frontier.’”

This space policy is part of a series of actions of by the Trump administration focused on developing and protecting key critical industries. In recent weeks, the administration has also released a national strategy for promoting and protecting critical technologies, and the U.S. Bureau of Industry & Security is currently seeking comments on strengthening the public health industrial base.

Export Opportunities Abound

Boundless opportunities exist for U.S. businesses when they export their products and services to foreign markets. In fact, over 95% of the world’s consumers are located outside of the United States. Opportunities are particularly plentiful in the space economy. As Secretary Ross identified – the global space economy will grow into a trillion dollar market over the next two decades. The aerospace, defense, and space industry is particularly impactful in Florida and the Washington, DC area economies. According to Enterprise Florida, Florida exports more than $7.2 billion in aviation and defense goods annually. Meanwhile, companies in the Washington, DC / Northern Virginia (many of which are in the defense and aerospace industry) received $80 billion in federal procurement awards in FY 2019.

Export Compliance

Although export opportunities abound, U.S. companies in the space industry should have a process in place to ensure they diligently and effectively comply with U.S. export control laws under the U.S. Department of Commerce’s Export Administration Regulations (“EAR”) and the U.S. State Department’s International Traffic in Arms Regulations (“ITAR”). A foundation of export compliance is developing an effective export compliance plan and holding regular export compliance training opportunities for your employees.

Contact Us

Diaz Trade Law has extensive experience in export compliance. We can help you develop or improve your export compliance plan, regularly train your employees, vet proposed transactions to ensure they do not violate U.S. export control laws, and develop a personalized export report card from your Automated Commercial Environment (“ACE”) data to ensure that you are proactive about your export and Customs compliance. Diaz Trade Law is also fully equipped during the COVID-19 pandemic to provide engaging online training. If you have questions about export compliance or any other trade or customs matter, reach out to us at info@diaztradelaw.com or call us at 305-456-3830.

Below we share some of our top 2020 success stories with you.

USTR/China Tariffs

• Diaz Trade Law assisted over 100 importers in filing complaints with the Court of International Trade challenging Section 301 tariffs imposed for imported goods under for List 3 and List 4a, requesting full refunds.

• Diaz Trade Law filed numerous exclusions for goods subject to the Section 301 List 3 and List 4. USTR agreed and granted our client’s exclusion!
• Numerous clients that were subject to 301 duties used Diaz Trade Law to actively monitor 301 exclusions to ensure they were notified when refunds were a possibility. Diaz Trade Law assisted with not only actively monitoring the relevant exclusions, but also interpreting the applicability, and fighting for refunds via the Protest or PSC process. CBP has accepted numerous Protests, and hundreds of thousands of dollars of refunds were sent to our clients!
• Diaz Trade Law published 49 blogs related to the US. – China Trade War to keep our clients and industry members up to date on the latest news.

EAPA Representation

• Diaz Trade Law is actively assisting an importer in fighting two CBP EAPA investigations.

Export Compliance and Enforcement Mitigation Assistance

• Diaz Trade Law is actively assisting exporters:
  • Vetting proposed export transactions
  • Providing voluntary self-disclosures to Census and OFAC
  • Developing an effective export compliance plan
  • Developing export compliance training
  • Mitigation and corrective action
  • Presenting export report cards to clients based upon an analysis of ACE data
  • Analyze export trade data
  • With mitigation of export seizures and penalties

USDA Representation

• Developed novel and unprecedented self-disclosure process with the National Organic Program in order to negotiate a settlement agreement obtaining maximum mitigation.
• Built corrective action systems and assist clients in implementing them.
• Developed written processes and procedures that align with national organic standards.

CBP Detention Assistance & 4647 Responses

• Mere days after being retained, Diaz Trade Law successfully assisted in negotiating with CBP and numerous trademark owners proving that our clients detained goods (collectively valued over $1,000,000.00) were legitimate, receiving either consent TM holder, and/or convincing CBP to release legitimate merchandise that should not have been detained.
• Diaz Trade Law successfully assisted our client in responding to CBP’s Notice to Redeliver (CBP Form 4647) and provided CBP confirmation that the intellectual property rights displayed on the goods was authorized and our client’s merchandise was released in record timing!

Successfully Assisted Numerous Importers in Various Seizure Cases

• Our client had over $200,000 worth of goods detained by U.S. Customs and Border Protection. The detention notice issued to our client said “IPR” only, which means “Intellectual Property Rights”. Our client had to answers as to why their goods were detained and what they could do to help get them back, until Diaz Trade Law got involved. Within 2 business days, Diaz Trade Law was able to communicate with the correct parties at U.S. Customs, and help facilitate the release of the legitimate goods. Needless to say, we had one happy client!
• CBP seized our client’s merchandise, valued at $132,756. After Diaz Trade Law’s successful petition, our client’s merchandise was returned!
• CBP seized our client’s merchandise, valued at $91,186.00. After Diaz Trade Law ‘s successful petition, our client’s merchandise was returned!
• Our client’s merchandise totaling $89,939.00 was detained by CBP. After Diaz Trade Law successfully communicated with the CBP detention office regarding the legitimacy of the detained goods, our client’s merchandise was released.
• Our client had 110 electric scooters, valued over $57,000 seized by CBP. After Diaz Trade Law ‘s successful petition, the scooters were returned to our client.
• CBP seized our client’s goods valued at $27,474.30. After Diaz Trade Law ‘s successful intervention, our client’s merchandise was returned!
• Our client had 4 checks, valued over $25,768.60 seized by CBP. After Diaz Trade Law’s successful petition, all checks were returned to our client.
• Our client’s merchandise valued at $16,990.00 was seized by CBP with an allegation that the merchandise was counterfeit. After Diaz Trade Law’s successful petition, CBP released our client’s merchandise!

Assisted Individuals in Getting Seized Currency Returned From CBP

• Our client funds, totaling $42,750.00 were seized by CBP. After Diaz Trade Law’s successful petition, $37,750.00 was returned to our client!

• $29,965 in currency was seized by CBP. After Diaz Trade Law ‘s successful petition, $27,465 was returned to our client.
• $23,552.00 in currency was seized by CBP. After Diaz Trade Law ‘s successful petition, $22,552.00 was returned to our client!
• $20,000.00 in currency was seized by CBP. After Diaz Trade Law’s successful petition, $19,000.00 was returned to our client!

Successfully Mitigated Penalty Actions Issued by CBP to our Clients

• Diaz Trade Law successfully mitigated a second Wood Packaging Material penalty on behalf of an importer. CBP assessed a $129,654.00 penalty, and after Diaz Trade Law ‘s successful Petition, the penalty was mitigated down to $23,337.72 (18% of the original penalty amount).

Risk and Analysis Survey Assessment (RASA)

• Diaz Trade Law successfully assisted our client in preparing for Risk and Analysis Survey Assessment (RASA) performed by CBP Auditors, resulting in no further consideration being necessary by CBP!

CBP 28 / CBP 29 Responses / Notices of CBP Investigation / Protests

• Our clients received numerous CBP 28’s and/or CBP 29’s stating they did not qualify for use of a Free Trade Agreement. Diaz Trade Law filed Protests with CBP proving that the goods did in fact comply with the Free Trade Agreement declared upon entry. CBP accepted the Protests and no duties were owed to CBP.
• Diaz Trade Law is proactively assisting companies who received Notices of CBP Investigation to analyze the potential loss of revenue, compliance with CBP laws and regulations, and assist in mitigating any potential enforcement action.

Binding Rulings

• Diaz Trade Law successfully requested and received binding rulings for numerous clients confirming:
  • the correct country of origin for its prospective imported merchandise.

• the correct harmonized tariff schedule (HTSUS) for its imported merchandise.
• both the origin of their merchandise and appropriate CBP country of origin marking
• the applicability of a free trade agreement.

CTPAT

• Diaz Trade Law assisted our client with its corporate and security profile (prior to the new 2020 changes being effective) and was successfully admitted as a certified partner into the voluntary Customs Trade Partnership Against Terrorism (CTPAT) program.
• Diaz Trade Law also provided assistance with annual updates and CTPAT training.

Foreign Trade Zone

• After Diaz Trade Law’s successful application, our client was approved by the Foreign Trade Zones Board and Port Miami as a FTZ under Grantee 281!

FDA – PPE

• Diaz Trade Law is successfully assisting three manufacturers of hand sanitizer product through the FDA recall process.
• Diaz Trade Law successfully assisted numerous clients in importing hand sanitizers (regulated by the FDA as an over-the-counter drug) and ensuring appropriate FDA registrations and listings, and compliant labeling was in place prior to importation.
• Numerous clients needed expedited assistance to import PPE into the U.S. Diaz Trade Law successfully assisted importers in reviewing and providing advice on OTC and medical device labeling, registering establishments with the FDA, listing medical devices with the FDA, and compliantly taking advantage of FDA’s EUA’s.

Assisted Numerous Importers in Filing Prior Disclosures Accepted by CBP

• Client received Requests for Information (CBP 28’s) from CBP and came to Diaz Trade Law noting a violation that took place. Diaz Trade Law filed numerous successful Prior Disclosures which will result in NO PENALTIES to our clients!
• Clients also proactively came to Diaz Trade Law after realizing they made errors in classification, valuation, and/or applicability of ADD/CVD orders when entering merchandise into the U.S. Diaz Trade Law successfully assisted our clients in filing Prior Disclosures which were accepted by CBP, resulting in no penalties!

Trademark

• Diaz Trade Law successfully assisted numerous clients in first performing a comprehensive search and thereafter registering our client’s trademark with the U.S. Patent and Trademark Office without opposition.

Awards

• In 2020, Diaz Trade Law found Jennifer Diaz became Chambers ranked in International Trade: Customs – USA – Nationwide

Publications

Key publications written by Diaz Trade Law in 2020 were:

• Export Laws. In: Int’l Law Deskbook 2020. Tallahassee: The Int’l Law Section of The Florida Bar, pp.33-54
• Trade Laws. In: Int’l Law Deskbook 2020. Tallahassee: The Int’l Law Section of The Florida Bar, pp.55-64.
• Customs Laws. In: Int’l Law Deskbook 2020. Tallahassee: The Int’l Law Section of The Florida Bar, pp.73-100.
• Bloomberg Law, USMCA IMPORT CONSIDERATIONS FOR PRACTITIONERS, June 26, 2020.
• Bloomberg Law, PPE IMPORTS DURING COVID-19, April 16, 2020.
• Bloomberg Law, CTPAT VALIDATION AND MINIMUM SECURITY CRITERIA & CTPAT MINIMUM SECURITY CRITERIA CHANGES, April 2, 2020.
• Bloomberg Law, USDA and CBP Combat Non-Compliant WPM, January 9, 2020.

Customized Training Programs & Webinars

Key compliance programs taught by Diaz Trade Law in 2020 were:

• 20/20 Focus on Trade, Focus on 301 Tariffs
• The ABC’s of Brand Protection
• Anchoring Trade Within South Florida
• Top CBP and FDA Enforcement Issues for Imports of FDA Regulated Products
• Proactive Enforcement of Your Brand
• Protecting Your IP Rights in China
• A View from the Marketplace: Opportunities for Florida Companies in Canada
• Forced Labor Enforcement and TFTEA: Enforcement is Here; How Does COVID-19 Play Into It?
• Intellectual Property Rights with Diaz Trade Law: A Practical Approach
• How Import Compliance ties into FDA Compliance: Your Checklist to Prepare for 2021

Diaz Trade Law values you and appreciates your trust in us to be your Customs and International Trade Law Expert! Contact us at info@diaztradelaw.com to schedule your consultation or customized training today.

U.S.-China Trade War

• BREAKING NEWS: U.S.-China Phase 1 Deal Is Officially Signed
• Expanded Export Control Obligations When Exporting to China
• BIS Expands Export Restrictions Targeting China’s Largest Chipmaker
• S. Ends Differential Treatment for Hong Kong

Section 301 China Tariffs

• NEW List 1- Section 301 Extensions
• China Tariff Update – List 2 Exclusions Extended
• NEW LIST 2- SECTION 301 EXTENSIONS
• LIST 3 Exclusion Updates
• List 3 Exclusion Extensions Granted – Did Your HTS Make the Cut?
• List 4 Exclusion Update
• More Section 301 Tariff Exclusion Requests Granted for List 4
• Fifth Round Of 301 Product Exclusions Involving List 4A – $300B
• 6th Round of Section 301 Tariff (List 1) Exclusions Extended
• Pending Section 301 Lawsuit Could Be A Windfall – But You Have to Act Now
• Exclusion Extensions Granted for List 4A
• Diaz Trade Law Now Filing List 4A Complaints – Join Section 301 Refund Lawsuit Now to Demand Refunds
• SECTION 301 TARIFF UPDATES: USTR GRANTS EXCLUSIONS & SEEKS COMMENTS ON PRODUCTS NECESSARY TO COMBAT COVID-19!

Section 301 Large Civil Aircraft Dispute

• USTR Seeks Comments on China Section 301 Product Exclusion Extensions & Enforcement of U.S. WTO Rights In Large Civil Aircraft Dispute

Section 301 Vietnam Investigations

• USTR Targets Vietnam In New 301 Investigations – Submit Request to Testify by Dec. 10

COVID-19

• BAN ON PPE EXPORTS UNDER DEFENSE PRODUCTION ACT
• PPE IMPORTS DURING COVID-19
• Due to Pandemic, BIS Providing Six-Month Export License Extensions
• SECTION 301 TARIFF UPDATES: USTR GRANTS EXCLUSIONS & SEEKS COMMENTS ON PRODUCTS NECESSARY TO COMBAT COVID-19!
• Diaz Trade Law Operations During the Coronavirus
• COVID FLEXIBILITY – FDA Announces Temporary Policy Regarding Certain Labeling Requirements for Foods
• Continuing Education for Licensed Customs Brokers – Comments Due December 28, 2020

Elections 2020

• Election 2020: Trump v. Biden On Trade
• Joe Biden & Trade – What Can Industry Expect from The New Administration?

USMCA

• USMCA Comment Opportunity – Due Dec. 31
• Implementing the USMCA’s Labor Chapter in Mexico

Forced Labor

• CBP Seizes $800k Of Human Hair from China Alleging Forced Labor
• Using WROS To Fight Forced Labor

U.S. Department of Agriculture

• USDA & CBP Combat Non-Compliant WPM

Customs and Border Protection

• CBP Creates New Online Electronic Vessel Manifest Confidentiality Application
• What You Missed at CBP’s Virtual Trade Week

Anti-Dumping and Countervailing Duty Investigations

• PC WIRE STRAND AVAILABILITY AT RISK

Trade Flows

• An Introduction to U.S. Trade Databases
• Florida’s Top 3 Export Markets

Imports

• HOUSEHOLD GOODS AND SERVICES PROVIDERS – WHAT YOU MUST KNOW

Protecting U.S. Critical Technologies

• Strengthening the Public Health Industrial Base Comment Opportunity Due December 23, 2020
• White House Releases National Strategy for Promoting and Protecting Critical Technologies
• Maritime Industry Rocked by Cyber Attacks

Foreign Corrupt Practices Act

• Goldman Sachs Pays $2.9 Billion In FCPA Settlement

Export Compliance

• The Importance of Regular Export Compliance Training for Your Business

Cuba

• U.S.-CUBA TRADE UNDER TRUMP VS. BIDEN

Brazil

• The U.S.-Brazil Trade Agreement Is Imminent

Caribbean

• INVESTING IN THE PETROLEUM INDUSTRY? – WHY HAITI
• The Caribbean Basin Trade Partnership Act Expired October 1 – What You Need to Know
• OPPORTUNITIES IN AGRICULTURE – WHY CHOOSE THE CARIBBEAN?
• USMCA Import Considerations for Practitioners
• NEW EXECUTIVE ORDER: Federal Agencies Directed to Remove Regulatory Barriers

U.S. Food and Drug Administration

• COVID FLEXIBILITY – FDA Announces Temporary Policy Regarding Certain Labeling Requirements for Foods

Intellectual Property

• FREE Webinar Series on Intellectual Property Rights
• President Calls for Greater Enforcement Against Counterfeit Imports

CTPAT

• CTPAT VALIDATION AND MINIMUM-SECURITY CRITERIA & CTPAT MINIMUM SECURITY CRITERIA CHANGES

Catch Up With DTL

• Join DTL And Walk for The Animals!
• DTL Tuned-In to the 2020 World Trade Center Miami’s International Trade Week – Check Out Our Recap:

If you have any questions on the topics above, contact us at info@diaztradelaw.com.

This year has been filled with numerous achievements and accomplishments. We are grateful for the clients who have entrusted their trade and customs issues to us, and we look forward to assisting you in 2020!

Below we share some of our 2019 success stories with you.

USTR/China Tariffs

• DTL published 25 blogs related to US. – China Trade War to maintain our clients and industry members up to date on the latest news.
• DTL filed numerous exclusions for goods subject to the Section 301 List 3.
• Our clients wanted to voice their concerns to the USTR Concerning the Proposed Modification of Action Pursuant to Section 301: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation for List 4. We assisted in creating compelling arguments to the USTR and submitting comments on their specific imported items subject to China Tariffs on List 4.

U.S. Food and Drug Administration (FDA) Detention

• FDA detained perishable merchandise, DTL successfully communicated with FDA by providing critical information for FDA to expeditiously release the detained goods totaling over $54,500.00.

 FDA FSVP Inspection

• DTL successfully assisted our client to prepare for FDA’s FSVP inspection. FDA issued a 482d to our client and conducted a Foreign Supplier Verification Program (FSVP) inspection. DTL was proactive in assisting our client in responding to questions from FDA during the inspection. At the conclusion of the inspection, the FDA did not take further action and did not provide the importer with Form FDA 483a.

FDA Import Alert List

• DTL successfully petitioned the FDA, and our client was removed from an FDA Import Alert List. Being on an FDA Import Alert list causes an importer to also be subject to automatic detention without physical examination each time they import, resulting in timely and costly delays to product admissions into the U.S. Our client stated “With the final detention now released, I just wanted to say a huge thanks for your specialized input over the past few months. In the end, we managed to escape the FDA mess with some significant legal bills and lost sales but without the loss of a major customer. It is going to take some time to re-establish our reputation in the market as a reliable supplier but, given at one stage we were within weeks of mass deletions, we ended up escaping ok.”

CBP Detention

• DTL successfully assisted CBP by providing critical information for CBP to expeditiously release detained goods totaling $70,100.00!

Successfully Assisted Numerous Importers in Various Seizure Cases to Assist in Getting Property Returned, Despite CBP Claims Merchandise Was Drug Paraphernalia, Counterfeit, Etc

• CBP seized electronics alleging they were counterfeit. DTL successfully petitioned CBP, leading to $138,585.00 worth of seized merchandise being released by CBP.
• Our client had $56,734.00 in goods seized by CBP for a failure to declare the goods upon entry into the U.S. After DTL’s successful Petition to CBP, a CBP decision letter was received confirming CBP will remit the forfeiture (i.e. return the seized goods) upon payment of a mitigated amount.
• CBP seized merchandise alleging it was drug paraphernalia. DTL successfully petitioned CBP, leading to $29,751.00 worth of merchandise being released by CBP.
• DTL successfully Petitioned CBP, leading to $7,200.00 worth of merchandise being released by CBP.

Assisted Individuals in Getting Seized Currency Returned From CBP

• Our client had $70,520 in Currency Seized by CBP. DTL successfully Petitioned CBP, leading to $60,520 in seized currency being returned to our client.
• Our client had $34,000.00 in Currency Seized by CBP. DTL successfully Petitioned CBP, leading to $31,500.00 in seized currency being returned to our client.
• Our client had $31,850.00 in Currency Seized by CBP. DTL successfully Petitioned CBP, leading to $31,850.00 in seized currency being returned to our client.
• Our client had $24,540.00 in Currency Seized by CBP. DTL successfully Petitioned CBP, leading to $23,540.00 in seized currency being returned to our client.
• Our client had $21,810.00 in Currency Seized by CBP. After DTL’s successful Petition, CBP issued a decision in 4 business days, which led to $20,810.00 in seized currency being returned to our client.
• CBP seized our client’s currency, alleged that our client purposefully split the currency among two travelers. DTL successfully Petitioned CBP, leading to $8,473.50 in seized currency being returned to our client.

Successfully Mitigated Penalty Actions Issued by CBP to our Clients

• DTL successfully Petitioned CBP, leading to a $360,000.00 penalty being mitigated down to $8,000.00.
• DTL successfully petitioned CBP, leading to a $42,193.00 WPM penalty assessed against our client being mitigated down to just $4,219.30!
• DTL successfully petitioned CBP, leading to two penalties of $10,000.00 assessed against our client being mitigated down to just $500.00 for each.
• DTL successfully petitioned CBP, leading to a $10,000.00 penalty assessed against our client being mitigated down to just $750.00!

Successfully Mitigated A Liquidated Damages Claim

• CBP issued a Liquidated Damages claim totaling $8,861.25 to our client. Our client attempted to Petition on their own behalf and was not successful. DTL successfully sent CBP a Supplemental Petition, leading to the Liquidated Damages claim of $8,861.25 being mitigated down to $147.68, a savings to our client of $8,713.57!

Assisted Numerous Importers in Filing Prior Disclosures Accepted by CBP

• Clients typically receive a CBP 28, which leads to further review of its import transactions. During the review, our client realizes they committed negligence when importing, and CBP has NOT yet commenced an investigation. We submit legally valid  Prior Disclosures to CBP.CBP accepts the disclosure with no penalties assessed to our clients!

Informed Compliance Letter

• DTL successfully communicated with CBP leading to CBP rescinding an Informed Compliance letter sent to our client.

CBP 28 Responses

• CBP questioned whether our client was properly utilizing the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR). DTL successfully responded to a CBP Request for Information (CBP28) providing confirmation that CAFTA-DR was properly used leading to CBP confirming the CBP 28 will be closed out with no further action taken!
• CBP questioned whether our client was properly utilizing the Agreement on Trade in Civil Aircraft. DTL successfully responded to a CBP Request for Information (CBP28) providing confirmation that the Agreement on Trade in Civil Aircraft was properly used leading to CBP confirming the CBP 28 will be closed out with no further action taken!
• CBP questioned whether our client was properly utilizing the The United States-Peru Free Trade Agreement (PTPA). DTL successfully responded to a CBP Request for Information (CBP28) providing confirmation that PTPA was properly used leading to CBP confirming the CBP 28 will be closed out with no further action taken!

 CBP 29 Response

• DTL successfully responded to CBP’s CF 29 proving that the correct AD/CVD case numbers were used upon entry. CBP agreed with DTL and liquidated the entries as entered saving our client over 118% in potential AD/CVD!

Protests

• DTL successfully protested two CBP bills totaling $72,684.58 and $105,971.29, respectively. Both bills were cancelled after DTL successfully proved our client’s goods were not subject to AD/CVD, saving our client $178,655.87!

CTPAT

• Assisted a consolidator in a successful validation with CBP.

First Sale

• DTL successfully worked with CBP to get an advisory opinion from CBP stating our client could use the “First Sale” value.

Country of Origin Marking

• DTL successfully worked with CBP after clients received a CBP Form 4647, had our client’s goods remarked with a correct country of origin and thereafter released by CBP.

Prepared Clients for CBP CEE’s Visits

• Our client received an Importer Visit notification from CBP. DTL successfully assisted our client to properly prepare for the CBP visit and attended to represent our client on site during the visit.
• CBP’s Apparel, Footwear & Textiles CEE requested an “Importer Interview” with our client. Jennifer Diaz went over our client’s importer practices and assisted in preparing our client for a successful visit with CBP. After the visit, our client said: “Thank you for all your assistance with today’s CBP visit. Our visit went as well as it possibly could have – we are so grateful that Diaz Trade Law represents U.S. Not only was Customs and Border Protection impressed, but they thanked us for how well prepared we were for their visit. One of the officials paid us a tremendous compliment when he stated that he wanted to start a venture based on our President’s business acumen and philosophies. Thank you again, for all the help you and your team provided us.”

Assisted Client in Getting Women’s Guayabera’s Duty Free Treatment Under the PATPA

• After years of hard work with the Panamanian National Directorate for the Administration of International Trade Agreements and Trade Protection (DINATRADEC), Oficina de Negociaciones Comerciales Internacionales, Ministerio de Comercio e Industrias, and the USTR, thanks to a Presidential Proclamation (84 Monday, No. 4 January 7, 2019 Pages 35–64 – GovInfohttps://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/FR-2019-01-07.pdf), women’s guayaberas will no longer be discriminated against and will now receive duty free treatment under PATPA, similar to men’s guayaberas. Client said, “Thank you for all the work you put in and the positive results.”

Foreign Trade Zone

• DTL successfully worked with the Port Miami (281) grantee, and the Foreign Trade Zone Board to receive the green light to operate as a FTZ, and DTL assisted our client in applying with CBP and received CBP approval to operate as a Foreign Trade Zone in Miami-Dade County. They will be offering freezer space!

Binding Rulings

• DTL successfully requested and received a binding ruling on behalf our client to confirm the correct harmonized tariff schedule of the US (HTSUS), country of origin, and applicability of a free trade agreement for its imported merchandise.
• DTL successfully requested and received a binding ruling on behalf of our client to confirm the correct harmonized tariff schedule (HTSUS) of its imported merchandise.

Assisted Client in Successfully Responding to A Cease and Desist Letter

• Our client received a Cease and Desist letter. DTL successfully responded to the letter, leading to the brand owner not taking any further action and closing the complaint.

Customized Training Programs

DTL and DTC taught the following customized training programs and webinar series:

• Webinar, The Florida Women’s Business Center, Global Connect, The Top 10 Tips When Importing into the U.S., December 3, 2019.
• Miami, FL, Global Ties, EU Program on Intellectual Property and Customs Management, November 21, 2019.
• Twitter Chat, OWIT International, “Women’s Entrepreneurship,” November 20, 2019.
• Miami, FL, “Lecture on International Trade Regulations for 2019 Cochran Fellowship Program on Supermarket and Retail Management from Paraguay,” Florida International University, November 12, 2019.
• Miami, FL, FIU College of Law’s Business Law Society and International Law Students Association, “Hot Topics in International Trade,” October 31, 2019.
• Tampa Bay, FL, Organize & Host & Moderate, OWITConTampaBay, October 24, 2019.
• Youtube, Trade Squad, Leah Goold-Hawes (Long Beach, CA), Sarah Barnes-Humphrey (Canada) and Audrey Ross (Canada) talk about Hot Topics in Supply Chain and Trade! October 21, 2019.
• Doral, FL, Africando, “Export Readiness: US Guidelines for Exporting to the US and Preparing Your Products for Distribution”, Wednesday, October 16, 2019.
• Fort Lauderdale, FL, FITCE, Broward County Office of Economic Development, Introduction to Importing, October 10, 2019.
• Miami, FL, Miami-Dade International Women Business Forum, Miami-Dade, Office of Economic Development & International Trade, October 8, 2019.
• Doral, FL, FCBF – “CTPAT Update on Minimum Security Guidelines”, September 25, 2019.
• Davie, FL, Panelist “Women in Law,” Nova Southeastern University, September 18, 2019.
• Webinar, “OWIT Committees/Opportunities for Volunteering Webinar,” OWIT International, June 6, 2019.
• Miami, FL – OWIT International / OWIT South Florida/ GMCC – Host and Moderate a Conversation with Ana Guevara, June 6, 2019.
• Doral, FL, Update to CTPAT, Trade War, CBP Enforcement, CoolTec Training, May 17, 2019.
• “The Complexities of International Trade Law,” Legal News & Review Radio Show, May 2, 2019.
• Doral, FL, “CBP COMPLIANCE & ENFORCEMENT”, DTC Seminar, April 17, 2019.
• Update on Ad Valorem, Maersk Training, April 9, 2019.
• Doral, FL, “CHINA TARIFFS/AD/CVD 101”, DTC Seminar, March 20, 2019
• Webinar, “CBP Enforcement – A Primer on Liquidated Damages, Penalty’s, Detention & Seizures,” NCBFAA, March 14, 2019.
• Miami, FL, “ABC’S OF PROTECTING YOUR BRAND”, DTC Seminar, February 20, 2019.
• Las Vegas, NV, Air Cargo Conference, Women’s Networking Panelist, February 10, 2019.
• Webinar, “OWIT International Benefits”, January 30, 2019.

Customized Trainings

• DTL organized customized trainings for clients on “CBP Compliance & Enforcement”.
• DTL organized customized trainings for clients on “FDA Compliance & Enforcement”.
• DTL provided a customized training to a client on best practices when complying with CBP Ad Valorem regulations.
• DTL provided a customized training to a client on MSC Updates to CTPAT, the Status of the China Trade War, and CBP Enforcement.

DTL values you and appreciates your trust in us to be your Customs and International Trade Law Expert! Contact us at info@diaztradelaw.com to schedule your consultation or customized training today.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

• Category I (proposed to be GRASE and not misbranded),
• Category II (proposed to be not GRASE or to be misbranded), or
• Category III (additional data needed).

The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Due to the changed conditions in the nearly 20 years since publication of the final rule ‘‘Sunscreen Drug Products for Over the Counter Human Use’’ (64 FR 27666, May 21, 1999) (nowstayed) (Stayed 1999 Final Monograph) have meant that additional safety data are now needed to establish that certain of the active ingredients listed in the Stayed 1999 Final Monograph are GRASE for use in sunscreen products. FDA generally intends to follow the current enforcement approach.

We can anticipate news or issuance of a final OTC sunscreen monograph by November 26, 2019 as the SIA calls for FDA to issue a final OTC sunscreen monograph to be effective within 5 years of enactment of the SIA, or by November 26, 2019 (section 586E(a) of the FD&C Act).

FDA is addressing multiple conditions of use applicable to sunscreen monograph products, including both the effectiveness of various SPF values and all marketed sunscreen dosage forms (and intends to do so in the final rule as well).

Below outline the 7 major provisions of the proposed rule:

1. Proposed GRASE Status of Active Ingredients Listed in the Stayed 1999 Final Monograph

• FDA’s approach to the clinical safety evaluation of OTC sunscreen active ingredients is based on FDA’s current scientific understanding regarding the safety evaluation of topical drug products for chronic use and involve topical safety studies (irritation, sensitization, and photo safety); bioavailability (absorption); and valuation of adverse events observed in clinical studies).
• FDA’s approach to the nonclinical safety evaluation reflected in the proposed rule is largely focused on potential long-term adverse effects or effects not otherwise readily detected from human use (i.e., carcinogenicity and reproductive toxicity).
• Results of Current evaluation for ingredients listed in the Stayed 1999 Final Monograph:
  • Category I: Sufficient safety data on both zinc oxide and titanium dioxide to support a proposal that sunscreen products containing these ingredients (at concentrations of up to 25 percent) would be GRASE, FDA is proposing that these ingredients are Category I.
  • Category II: Safety data for aminobenzoic acid (PABA) and trolamine salicylate, however, has caused FDA to conclude that the risks associated with use of these active ingredients in sunscreen products outweigh their benefits. In the case of trolamine salicylate, these risks include the potential for serious detrimental health effects (including bleeding) caused by the anti-coagulation effects of salicylic acid and increased risk of salicylate toxicity when this ingredient is used in sunscreens. For PABA, the risks include significant rates of allergic and photoallergic skin reactions, as well as cross-sensitization with structurally similar compounds. Accordingly, FDA is proposing that these two ingredients are Category II.
  • Category III: Because the public record does not currently contain sufficient data to support positive GRASE determinations for cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, or avobenzone, FDA is proposing that these ingredients are Category III.
    • The significant systemic availability of oxybenzone, coupled with a lack of data evaluating the full extent of its absorption potential, is a concern to FDA, among other reasons, because of questions raised in the published literature regarding the potential for endocrine activity in connection with systemic oxybenzone exposure. Nearly all of these sunscreen active ingredients also have limited or no data characterizing their absorption.

2. Proposed Requirements Related to Dosage Forms

 FDA is proposing the following dosage forms as:

• Category I: Oils, lotions, creams, gels, butters, pastes, ointments, and sticks. As well as spray sunscreens, subject to testing necessary to minimize potential risks from unintended inhalation (particle size restrictions) and flammability (flammability and drying time testing), together with related labeling requirements.
• Category III: sunscreen powders – subject to particle size restrictions if found to be GRASE will be included in the final monograph.
• FDA is proposing that sunscreens in all other dosage forms—including wipes, towelettes, body washes, and shampoos—are new drugs because FDA did not receive data showing that they were marketed prior to 1972, as required for inclusion in the monograph.

3. Proposed Maximum Sun Protection Factor and Broad Spectrum Requirements

 FDA is now proposing

• • To raise the maximum labeled SPF value to SPF 60+. Given the lack of data showing that sunscreens with SPF values above 60 provide additional meaningful clinical benefit, FDA is proposing not to allow labeled SPF values higher than 60+.
  • To permit the marketing of sunscreen products formulated with SPF values up to 80.
  • Not to allow the marketing (without an approved NDA) of sunscreen products with SPF values above SPF 80.
  • Require that all sunscreen products with SPF values of 15 and above satisfy broad spectrum requirements.
  • To add to the current broad spectrum test a requirement that broad spectrum products meet a UVA I/UV ratio of 0.7 or higher.
  • Sunscreens with SPF 2 to 14 are not required to pass the revised broad spectrum test.
  • To require that sunscreen products with SPF values of 15 or above be labeled with an SPF number corresponding to the lowest number in a range of tested SPF results. For example, sunscreens testing at SPF 15–19 would be labeled ‘‘SPF 15’’; those testing at 40–49 would be labeled ‘‘SPF 40.’’
  • That sunscreens testing at SPF 30 or more be labeled in increments of 10 (i.e., SPF 30, SPF 40, SPF 50, with a proposed maximum of SPF 60+), that sunscreens testing at SPF 15 to 29 be labeled in increments of 5 (i.e., SPF 15, SPF 20, SPF 25), and that the requirement that labeled SPF values correspond to ranges (rather than precise numerical values) is not necessary below SPF 15.

4. Proposed PDP Labeling Requirement

• FDA proposing to partially revise the current requirements for information that must appear on the principal display panel (PDP) of sunscreen products.
  • The PDP is the part of a product label that is most likely to be viewed or examined when the product is displayed for retail sale.
• A major feature of the PDP is the statement of identity (SOI). FDA is proposing that the SOI consist of an alphabetical listing of the sunscreen active ingredients in the product, followed by ‘‘Sunscreen’’ and the product’s dosage form (such as lotion or spray).
  • This information would supplement other important elements of the PDP (e.g., SPF, broad spectrum, and water resistance information).
  • FDA believes/ argues that permitting consumers to more readily compare products and either select or avoid a given product accordingly. For sunscreen products that have not been shown to help prevent skin cancer or early skin aging caused by the sun, the SPF statement would be followed by an asterisk (*) directing consumers to see the ‘‘Skin Cancer/Skin Aging alert’’ elsewhere we are revising the
  • FDA is also revising the format requirements for the SPF, broad spectrum, and water resistance statements on the PDP.

5. Proposed Requirements Related to Final Formulation Testing Processes and Recordkeeping

• To ensure that FDA can assess compliance with our regulations, FDA is proposing to require records of required final formulation testing of sunscreen products to be maintained for 1 year after the product expiration date, or, if the product is exempt from expiration dating (as most sunscreens are), for 3 years after distribution of the last lot labeled in reliance on that testing.
• In addition, FDA is proposing to require responsible persons to keep records of sunscreen formulation testing, and clarifying that required records would be subject to FDA inspection.
• FDA is also proposing a number of revisions to our labeling and testing regulations designed to clarify FDA expectations about clinical final formulation testing processes and to ensure that the testing of marketed sunscreen products is conducted in a manner that both protects human subjects and produces reliable results.

6. Proposed Status of Sunscreen-Insect Repellent Combination Products

• The proposed rule also addresses sunscreen-insect repellent products, which are jointly regulated by FDA as sunscreen drugs and by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
• FDA is proposing to classify these products as Category II as DEET may increase absorption of components. 

7. Proposed Actions to Effectuate Lifting of Stay and Harmonize Impacted Regulations

• FDA is proposing to lift the stay on the 1999 Final Monograph and have proposed revisions to applicable regulations necessary to effectuate the lifting of the stay and to harmonize any impacted regulations.

 DTL assists clients in complying with FDA regulations. Contact us today to for a label review and to explain in detail the proposed changes! Our Customs and International Trade Law attorneys are available at 305-456-3830 or info@diaztradelaw.com.

United States Customs and Border Protection (CBP), one of the principal agencies under the leadership of DHS, has released an updated list detailing items prohibited from entry into the US. These goods fall under a variety of classifications, including “dangerous toys, cars that don’t protect their occupants in a crash, bush meat, or illegal substances like absinthe and Rohypnol”.

Many of these items are available for legal purchase while abroad, presenting a potential quagmire for international travelers. In order to avoid purchasing and effectively smuggling these illegal goods into the country, CBP recommends travelers to familiarize themselves with the given prohibited and restricted items prior to departure.

Due to the hundreds of laws that regulate and restrict the importation of goods into the US, one must understand the given consequences prior to purchase. These items are not limited to individual travelers attempting to bring back souvenirs from vacation, rather they place a much heavier burden on potential importers.

Considering that fair and free trade reside highly on the government’s priorities, many seemingly harmless goods are subjected to extra scrutiny, as well as duties or penalties. Many importers of prohibited or restricted items may not even be cognizant of their malfeasance. However, ignorance is not a defense for criminality. For this reason, DTL highly recommends international travelers and importers alike to review the listed items and they perform pre-compliance PRIOR to importing.

Diaz Trade Law provides expert assistance primarily for companies attempting to comply with the multitude of U.S. federal laws and regulations related to both import and export transactions as well as supply chain security. We are passionate about strategizing with clients to achieve successful results and optimizing compliance with U.S. federal government agencies. We represent global clients of every size, from individuals and small businesses to Fortune 500 companies. For more information, call us today at 305-456-3830 or email info@diaztradelaw.com.