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I have previously described concerns about the lack of validation of genetic tests to refute the pedigree registration status of purebred dogs.  As several courts have held, genetic testing is currently not dispositive of pedigree registration status.  See, e.g., Sandra Shines v. Furry Babies Stratford Square, Inc., No. 13-3592, slip op. at 9 (Ill. 18th Jud. Cir. Jan. 22, 2014) (finding DNA test results unreliable to support plaintiff’s claim that the Cocker spaniel in dispute was a mixed breed).

It looks like I am not the only veterinarian concerned about the injudicious use of genetic testing in animals.  As other veterinarians and scientists recently discussed in Nature’s “Pet genomics medicine runs wild:”

Genetic testing for dogs is big business.  It is too easy for companies to sell false hope, warn Lisa Moses, Steve Niemi and Elinor Karlsson.  They call for regulation.

These authors identify the following deficiencies in animal genetic testing:

  1. Weak science
  2. Lack of validation
  3. Imprecise results or interpretation
  4. Conflicts of interest

They propose the following logical five-step plan to help insure that genetic testing provides animal owners with validated, science-based and valuable information about their pets.

  1. Establish standards
  2. Create guidelines
  3. Share data
  4. Recruit tools and expertise
  5. Education counsellors

The International Partnership for Dogs (IPFD) a partnership of national kennel clubs, industry and non-profit organizations, whose mission (described here) “is to facilitate collaboration and sharing of resources to enhance the health, well-being and welfare of pedigreed dogs and all dogs worldwide” congratulated the authors on their commentary and noted that to their own initiative – the Harmonization of Genetic Testing for Dogs (HGTD) – was engaged in the development of oversight of these tools and emphasized “the phenomenal potential for genetic testing to support health, well-being and welfare in dogs, as well as aspects of human-dog interactions.”

The goal of HGTD is reportedly to improve standardization of, and access to, robust genetic  testing to support health improvements and a sustainable future for healthy dogs.

The use of genetic tests to assist animal breeders in selecting for desired traits is nothing new.

For example, in 2006, USDA’s Agricultural Research Service was studying the use of genetic tests for “beefing” up cattle breeding programs, as reported on USDA’s website.  Even before that, as early as 1998, geneticists, including Mark F. Allan was researching the “genetic regions linking to the twinning trait” in cattle.

Marker-assisted selection will allow breeders to increase the speed and accuracy of traditional assessment methods, but its advantages extend beyond the seedstock industry. Commercial cattle producers would be able to purchase bulls with superior genetics. The desirable characteristics in the livestock would ultimately translate into better products for consumers.

Genetic testing, when used judiciously, has helped animal and human health officials understand the spread of pathogens, such as avian influenza, so that measures can be implemented to prevent or mitigate such spread.

Undoubtedly, the use of genetic testing will continue to advance, and provide benefits to both animals and humans invested in their care.

 

The unfortunate and misguided bans of sales of professionally and purposely-bred dogs throughout the United States (which as previously described violates the constitutional rights of many and exposes people and pets to a host of infectious, sometimes deadly diseases), reveals a dearth of objective and science-based research about the welfare of dogs (and puppies) historically provided to the public from breeders through pet stores compared with the welfare of these pets sold (aka adopted) through rescue and shelter channels.

Fortunately, through the work conducted at universities, including, for example, Purdue University’s Center for Animal Welfare Science (“CAWS”), and Mississippi State University College of Veterinary Medicine, peer-reviewed, science-based research is underway and the results published.

At Purdue’s CAWS, researchers “facilitate the well-being of animals using sound science and ethics to investigate and promote the best animal care and management practices.”

Dr. Candace Croney and her research group, study the “Welfare of Breeding Dogs.”

The welfare of dogs housed in commercial breeding facilities is of great public concern.  However, little research has been performed to examine the welfare status of the dogs on-site at kennels, characterize the nature and extent of welfare problems experienced, and explore solutions. We are developing tools to evaluate the behavioral and physical welfare of commercial breeding dogs and create practical recommendations to improve their lives and those of their puppies.

In addition to studying techniques and practices used by dog breeders, the group also studies the multi-factorial issues involved when people chose to adopt or purchase a new dog.  Researchers conclude, as reported in “Factors that impact dog selection and welfare:”

Dogs are not selected based on a single factor. While animal shelters and rescue organizations work hard to encourage the adoption of the dogs under their care, they may not be able to meet the demand for purebred dogs. This demand creates the need for a solution that balances consumer freedom of choice as to where (and how) to obtain a dog with ethical concerns about procuring dogs from sources where animal welfare is not adequately protected.

Notably, the paper also identifies the fact that, regardless of the source, pets can experience varying levels of welfare.  Increasingly, as shelters are pressured into decreasing numbers of animals euthanized (a laudable goal, when properly implemented), shelter residents are moved from shelter to shelter or rescue or even adopted out, even when behavioral and/or medical abnormalities exist.

A study recently conducted at the MSU College of Veterinary Medicine attempted to take a sharp, science-based look at brick and mortar shelter populations in the United States.

One of the authors (Kimberly Woodruff) noted:

For many years, people have quoted numbers of animals going in and out of shelters, but there’s never really been any research behind them . . .Even beyond that, nobody really knows how many shelters are in the United States. There’s no official registry for shelters and no group providing oversight. Shelters can be anything from a few kennels to a huge facility that adopts out thousands of animals a year.

As previously discussed, the National Animal Interest Alliance has been tracking the movement of dogs and cats into and out of shelters, using data obtained from government agencies, and reporting this information on the NAIA Shelter Project.

Both the MSU research and the Shelter Project are hampered by the unreported movement of pets through rescue organizations, which are often completely unregulated, are not required to register or obtain a license to function, and do not report animal movement to any agency.  Some states have adopted laws governing these entities, including those in the Northeast, like Connecticut and Rhode Island, where so many transplanted pets are relocated.

As the MSU study discussed, concerns about the spread of diseases and pests through adoption networks must be addressed:

‘For example, there are a lot of dogs moving out of the Southeast and into other regions,’ [researcher] Smith said. ‘Well, this is a highly endemic heartworm disease area, we possibly could be transporting heartworms across the country. That means we need to do due diligence to control that disease. We may need to ask those shelters about how they’re addressing heartworm disease and other regional diseases.’

On Wednesday, November 15, 2017, Las Vegas City Council voted to enact “Bill No. 2017-40 – which repeals a formerly adopted ordinance which prohibits pet shops from selling or disposing of dogs, cats or potbellied pigs other than those obtained from an animal care facility or nonprofit animal rescue organization.”

As both the American Kennel Club (AKC) and Pet Industry Joint Advisory Council (PIJAC) stated in written testimony, the misrepresentations about the puppies sold at pet stores harms puppies, breeders, pet stores and consumers by removing a highly regulated source of healthy puppies for people desiring a lifelong pet with specific behavioral and physical characteristics they prefer for their families.

As PIJAC explained:

Even as we have worked to raise standards of care, PIJAC has battled misconceptions about the quality of pet store animals and the sources of such animals. The unsubstantiated assertion that pet store animals generally come from substandard breeding facilities is commonly used as a smoke screen to obscure the fact that the overwhelming majority of pet owners who choose to purchase from pet stores bring home a happy, healthy pet and remain highly satisfied with their pet store experience.

The reality is that almost all pet store puppies originate from USDA licensed breeders who are regularly inspected and found to comply with appropriate care standards. By contrast, many of the dogs and cats from other sources, including rogue Internet operators, private sales, shelters and rescues, did not come from licensed breeders.

AKC stated:

An important part of ensuring the success of a pet with a new owner is to ensure that it is an appropriate fit with the owner’s lifestyle. Treasured pets may be obtained from a variety of sources, including breeders, pet stores, rescues, and local shelters.

Under the current law, families in Las Vegas have lost an important source for choosing a quality pet that is the best fit for their lifestyle and circumstances.

There is no credible evidence that puppies purchased from pet stores originate from “puppy mills,” large commercial substandard breeding facilities, or that pet store puppies contribute to shelter populations-misrepresentations that form the bases for pet store sourcing bans.

Las Vegas City Council repealed the pet store sourcing ban. Hopefully, other communities will follow suit.

On a related note, Circuit Judge Hamilton dissented from the majority opinion in a constitutional challenge to a pet store ban in Chicago (Park Pet Shop, Inc. v. City of Chicago, 872 F. 3d 495 (7th Cir. 2017) “[o]n two points critical to the federal Commerce Clause claim.”

First, the Supreme Court itself has not yet confined the balancing test under Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), as narrowly as my colleagues suggest. The majority writes that Pike balancing comes into play ‘only when the law discriminates against interstate commerce in practical application.’ Ante at 502 (emphasis in original), citing National Paint & Coatings Ass’n v. City of Chicago, 45 F.3d 1124, 1131 (7th Cir. 1995) . . . . The majority would apply Pike only when the challenged law gives ‘local firms any competitive advantage over those located elsewhere’ . . . The Supreme Court’s more recent discussions of Pike, since we decided National Paint in 1995, are difficult to reconcile with this approach. For example, the Court has explained that federal courts ‘generally leave the courtroom door open to plaintiffs invoking the rule in Pike, that even nondiscriminatory burdens on commerce may be struck down on a showing that those burdens clearly outweigh the benefits of a state or local practice.’

 

Judge Hamilton also found that “the majority errs by applying a stringent version of Iqbal and Twombly to find that plaintiffs have not plausibly alleged sufficiently burdensome effects on interstate commerce.”

 

Judge Hamilton found that the complaint had sufficiently alleged plausible impacts that the pet store sourcing ban would result in the alleged harms, concluding,

I don’t know whether the plaintiffs in this case could ultimately meet the demands of the Pike balancing test. They should be permitted to try, though, particularly now that the ordinance has taken effect and evidence of actual effects should be available. I would reverse the dismissal for failure to state a claim and remand for further proceedings.

 

 

As USDA had previously suggested, it just posted a new version of the searchable database that had been dismantled this past February.  Access to the new version is available here.

Many animal rights organizations and animal-trade organizations had expressed outrage or concern when USDA initially dismantled its database.  The current version may not effectuate changes to those positions, since much of the information about individual licensees (compared to licensed businesses) appears to be redacted.

Also, it seems as if license numbers are not available for individuals, but it could be I need to more carefully review the instructions for searching the new database to find that information.

It is a given, that those clamoring for this data will be hard at work deciphering what is and what is not available.

For those pet stores and dealers in towns, cities and states that are required to provide inspection reports to sell puppies, it seems as if the only way to provide such documents from breeders licensed as individuals is to obtain the reports directly from those breeders.

Genetic testing in human and animal medicine has been used for some time, and shows great promise, when used judiciously.  For example, genotyping the avian influenza virus and other pathogens has helped animal and human health officials understand the spread of pathogens so that measures can be implemented to prevent or mitigate such spread.

As reported by Greg Cima, “[f]aster, cheaper genome sequencing is helping public health researchers identify the risks of drug resistance and medical treatment failure . . . The sequences also may help federal investigators find outbreak sources, by geographic location and species, as well as guide vaccine and antimicrobial development.”  Finding risks in a flood of genetic data, JAVMAnews Issues, Aug. 1, 2016. .

According to Dr. Jerold Bell, a small animal practitioner and adjunct professor at the Tufts University Cummings School of Veterinary Medicine, “[c]ompanies are using diagnostics to determine what breeds exist in a mixed-breed dog . . . Some companies take it one step further and also tests for genes controlling body conformation and known disease-causing mutations.”  M.S, Filippo, Genetic testing for pets quickly catching up to its human counterpart, AVMA press release, 8/8/2016.

Diagnostic test results are rarely dispositive, and the reliability of the results can be influenced by many factors, including, but not limited to: sample collection; quality control and quality assurance of test reagents; method and proficiency of testing; and interpretation of test results.  Even tests performed by USDA-APHIS-approved laboratories that are part of the National Animal Health Laboratory Network, using reference materials and proficiency tests produced at the National Veterinary Services Laboratory that are accredited to international standards, must be interpreted by knowledgeable clinicians.

As a large animal veterinarian, when I received laboratory results from state or private laboratories that did not seem consistent with my patient’s clinical signs, I would consult with the laboratory director and other officials to discuss those inconsistencies.  Sometimes, additional testing was warranted.  In some cases, the final results were never definitive.

As the Director, Division of Animal Health, New Jersey Department of Agriculture I was responsible for the oversight of the only animal health diagnostic laboratory in the State, and for interpreting laboratory results related to regulated and reportable diseases.  That analysis started with the laboratory test results, and where the results appeared inconsistent with the clinical signs of the tested animal, an in depth review of the testing process from sample collection to results ensued.

Based on this extensive background and understanding of testing, I am concerned about the inappropriate use of certain genetic tests to refute the pedigree registration status of purebred dogs.  As several courts have held, genetic testing is currently not dispositive of pedigree registration status.  See, e.g., Sandra Shines v. Furry Babies Stratford Square, Inc., No. 13-3592, slip op. at 9 (Ill. 18th Jud. Cir. Jan. 22, 2014) (finding DNA test results unreliable to support plaintiff’s claim that the cocker spaniel in dispute was a mixed breed).

Mars Veterinary, a business unit of Mars Petcare that sells a DNA genetic test called Wisdom Panel® warns that the test is not “intended to be used in any judicial proceedings” and further suggests that “[i]f questions arise as to a purebred dog’s pedigree and breed ancestry, parentage testing through the AKC is the appropriate course of action. For this evaluation, the documented sire and/or dam are examined to ensure they were the genetic contributors to the dog in question. If they are confirmed as the parents, their pedigree (and breed) is conferred onto the puppy.”  See Wisdom Panel® Terms and Conditions.

The purebred status of dogs is based on documentation confirming each dog’s lineage, required by the relevant breed canine breed registries—not the results of DNA testing.  Similarly, ancestry DNA testing in humans could not be used to nullify the citizen status of a third-generation U.S. citizen, no matter what their genetic makeup reveals.

The proper use of genetic testing is reflected in AVMA’s new policy on “Inherited Disorders in Responsible Breeding of Companion Animals” which “supports research in genetic and inherited disorders to better educate the profession and breeders on identifying and minimizing inherited disorders in companion animal breeding programs.”  K. Burns, AVMA passes policy on responsible pet breeding, JAVMAnews, Feb. 15, 2017.

Undoubtedly, genetic testing will be used as a increasingly important tool for pathogen tracking, disease control purposes, to help guide responsible dog breeders and to help identify the genetic make-up of mixed breed dogs, with unknown pedigree.

 

New Jersey Senate Bill No. 2847,  introduced on December 12, 2016 would make some important beneficial changes to the laws governing animal rescue organizations and shelters in New Jersey, but would also require the unnecessary and harmful premature spay and neuter of cats and dogs before sale from pet shops, kennels, shelters, pounds, and animal rescue organizations.

Considering the positive amendments first, the bill would require registration of all animal rescue organizations with the State Department of Health.  Registration is currently voluntary.

Pursuant to Public Law 2011, Chapter 142, the New Jersey Department of Health shall establish a voluntary registry of animal rescue organizations and their facilities.

As of November 3, 2016 there were 70 in-state and out-of-state animal rescue organizations voluntarily registered in New Jersey, as listed on the DOH website.

Registration and oversight of animal rescue organizations is sorely needed.

Another positive amendment in S2847 is the ability of shelters or pounds to euthanize an animal surrendered by its owner before the current seven-day waiting period, and the ability to euthanize a stray or an animal surrendered by someone other its owner if a veterinarian determines “that the animal is in extreme pain and cannot recover from the illness or condition that is causing the pain.”

A veterinarian should make this determination for animals surrendered by their owners or other individuals for at least 2 reasons: (1) proper animal ownership can be difficult to determine; and (2) the irreversible decision whether or not to euthanize an owned pet should be decided by a veterinarian, trained and licensed to make such determinations.

As for the requirement to spay or neuter a dog or cat before sale, so long as the animal is merely two months old, for reasons previously discussed, this premature, unnecessary elective surgery at so young an age exposes each animal to short and long-term injury and harm.  Increasingly, scientific evidence proves that the early removal of endocrine glands, such as testes and ovaries, increases the incidence of certain metabolic disorders, including some forms of cancer, and can decrease the lifespan of certain pets.  The decision about when to spay or neuter an individual pet should be determined by the owner in consultation with their veterinarian, after learning about the risks and benefits of such procedures.  Veterinarians are increasingly advising dog owners to wait until at least after the pet’s first reproductive cycle to sterilize their dog.  The requirement remains with each owner to ensure that their pet is not irresponsibly bred until it is spayed or neutered.

Finally, the requirement for shelters and pounds to pay owners up to $250.00 for any pet released before it is spayed or neutered could have a devastating impact on these organizations who are already struggling to compete with animal rescue organizations.

If amended to address these concerns, S2847 could be supportable.

 

On Monday, November 14, 2016, the Assembly Environment and Solid Waste Committee will consider the Assembly version (A2338) of Senator Lesniak’s amendments to the Pet Purchase Protection Act (S63).  The problems with these amendments were previously discussed here.

Anyone interested in testifying should attend the Committee meeting at 2:00 PM Committee Room 9, 3rd Floor, State House Annex, Trenton, NJ.

Since its passage in the Senate, there has not been much action with the Assembly version of S63.

However, as recently reported by Andrew George on njbiz.com

“Lesniak says he’s planning to amend the bill” to address concerns of pet store owners and their sources, including “eliminating the grandfathering portion of the measure and lifting the restriction on new pet stores to only source from kennels, shelters or animal rescues.”

However, there is no new version of the bill with these amendments to review.

Even with these amendments, the bill and the existing law, impermissibly bans sales to pet stores from licensed breeders who have not been finally determined to have violated the Animal Welfare Act (AWA).

The Pet Protection Act bans sales to pet stores from licensed pet dealer who:

  • has been cited on a USDA inspection report for a direct violation of the federal AWA or corresponding regulations during the two-year period prior to purchase;
  • has been cited on a USDA inspection report during the two-year period prior to the purchase by the pet store for three or more indirect violations of the Awa or corresponding regulations.
  • is cited on the two most recent USDA inspection reports prior to the purchase of the animal by the pet shop for no-access violations.

As recently discussed in Pet Stores Under Attack, only an USDA Administrative Law Judge can make a determination that a licensee has violated the AWA. A noncompliant item on an inspection report does not constitute a violation of the act.

Individual pet stores and customers can (and should) review USDA reports and determine, on a case-by-case basis, whether to purchase from particular breeders.

S63, the year-old amendments to the PPPA and similar ordinances will not (and have not) affected any actual puppy mills, because, as defined by USDA’s OIG, these facilities are large commercial unlicensed breeders. Banning sales from hobby breeders, exempt from USDA licensure because these breeders provide humane care to their dogs, will not affect puppy mills.

Shelters, Rescues, and pet stores all provide pets for consumers. The transfer of ownership is the same, whether described as an “adoption” or “sale.” Both the federal and state governments consider the transfer of ownership from these entities to be equivalent. The transfer of money for these pets is considered remuneration, whether based on a sale, adoption fee or donation. USDA “consider[s] acts of compensation to include any remuneration for the animals, regardless of whether it is for profit or not for profit.” The critical question is whether the comparators serve the same market, not whether the articles of commerce are identical.

Pet stores, shelters and rescues are all considered “pet dealers” as defined by Congress in the AWA and USDA. A pet dealer is “any person who, in commerce for compensation or profit delivers for transportation . . . buys, sells or negotiates the purchase or sale of any dog or other animal . . . for use as a pet.”

The legislative history of the AWA makes clear that this definition was “intended to include nonprofit or charitable institutions which handles dogs and cats” and that the definition of “dealer” was “not intended to exclude from licensing or regulation those nonprofit or charitable institutions or animal shelters which supply animals in commerce to research facilities for compensation of their out-of-pocket expenses.”

Importantly, the Mayor’s Alliance for NYC’s Animals, a 501(c)(3) non-profit charity, has been functioning as an unlicensed USDA Class B dealer by transferring animals from the City’s Shelters to more than 140 partner Rescues in a program called the New Hope Transfer Program. Alliance President “Hoffman said she thinks of the Transfer Program as a giant distribution network with AC&C as the ‘wholesaler’ and the partner organizations as ‘retailers’ who get the animals face-to-face with the public.”

Like pet stores, rescues and some shelters import dogs into the Northeast for sale/adoption, similar to the business model of a pet store. The biggest difference between pet stores, rescues and shelters is that pet stores and their sources are highly regulated and shelters and rescues are not.

The explosion of interstate and international transportation of dogs and cats through rescue channels, largely unregulated, exposes humans and animals alike to infectious, contagious diseases and parasites. As a result, state animal health officials adopted or amended state laws to regulate animal transfers from shelters and rescues in similar or more stringent ways than sales from pet stores. USDA and CDC have also issued alerts and amended regulations to prevent disease spread from pets imported from other countries for sale in rescue channels in the U.S.

One of the most profitable shelters/rescues in the NYC area, the North Shore Animal League (NSAL), advertises that they sell dogs and cats throughout the City, which they regularly obtain from substandard breeders throughout the country. According to their website, they “reach across the country to rescue animals from overcrowded shelters, unwanted litters, puppy mills, natural disasters and other emergencies and find them permanent, loving homes.”

NSAL rescued at least 3,562 pets from 13 states and Puerto Rico from December, 2010 until December, 2014. This is a highly lucrative business. In Fiscal Year 2013, NSAL reported: total revenues of $35,655,064, with $1,524,982 for its Pet Rescue and Adoption; compensation of current officers, directors and key employees totaling $1,611,478; and payment of other salaries and wages totaling $10,210,036. NSAL also reports that it contracts with other rescues and shelters, obtaining and importing pets for adoption from other states to the State and City.

For example, Precious Friends, a shelter in Tennessee contracts with NSAL to “take [animals] from shelters located in Tennessee, Kentucky, Georgia, Ohio, Texas, Illinois, Louisiana, Arkansas, Alabama, and Indiana” and send them to NSAL.

More recently, NSAL has advertised to purchase puppies from any source for resale.

 

At its core, the Law is an attempt at economic protectionism of the City’s favored source of pets, animal shelters and rescues, who are expressly exempted from the Laws’ sourcing restrictions and mandatory sterilization requirements for pet stores, and discriminates against articles of commerce (puppies) coming from other states based simply on their origin from Class B licensees. See Philadelphia v. New Jersey, 437 U.S. 617, 626-627 (1978)

This law does not protect the public health or welfare, an oft-cited defense used by cities like New York in response to constitutional challenges that the laws violate the Commerce Clause.

If the City wanted to ban the importation of puppies to protect human or animal health, it could do so by banning the importation of all puppies from any source. Instead it has, in practical effect, banned the importation of the highly regulated, inspected, purposely bred and humanely raised healthy puppies from Class B licensees to pet stores, and favors the importation of dogs known to have the highest incidence of infectious diseases, behavioral and physical disorders from retail rescue channels.

The City said the Law is needed to prevent the sale of puppies from puppy mills, where they claim pet stores obtain their puppies. First, pet stores do not buy from substandard, large commercial breeders, known as “puppy mills.” NYC pet stores buy their puppies from either USDA licensed breeders with 5 or more females that have not been finally determined to have violated the Animal Welfare Act or breeders with 4 or fewer females whom USDA has determined do not have to be licensed because they exceed humane standards of care. These purchases are commonly made with the assistance of Class B dealers who serve as the wholesalers, or middlemen of the interstate pet market. Since the Law bans sales from Class B dealers to pet stores, it creates an impermissible burden to interstate commerce.

The Law discriminates against the sources NYC pet stores rely upon (Class B’s and their sources) who are out of state and favors the in state rescues and shelters who obtain their animals from unlicensed sources.

Further, the burden imposed on interstate commerce is quantitatively and qualitatively different from that imposed on intrastate commerce, a critical element in commerce clause analysis. National Electrical Manufacturers Ass’n. v. Sorrell, 272 F.3d 104, 109 (2nd Cir. 2001) The Law forces the entire regulated interstate pet market to change their marketing practices, but does not require NYC’s shelters and rescues to make any changes.

This Law, along with the 140 other pet store sourcing bans that HSUS says have been passed throughout the country, has already impacted the interstate pet market.

For example, the USDA-estimated there are between 5,800-10,360 exempt breeders throughout the country, will be unable to sell to pet stores in the City. For these breeders to sell to pet stores in the City, they will have to add breeding females and become Class A licensed breeders.

From 2008 to 2014 the number of Class A breeders decreased by 75%, in large part as a result of pet store sourcing bans. Class A breeders will have to add staff and marketing efforts that they currently rely on Class B dealers to provide. Many Class A breeders cannot expand their businesses, and therefore will be unable to sell to NYC pet stores.

From 2008 to 2014 Class B pet dealers decreased by 85%, in large part as a result of pet store sourcing bans. The City bans Class B sales to pet stores entirely. Because the New York City market is the largest pet market in the country, the impact of this Law to the interstate market will be significant.