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Bioaccumulation assessment criteria relatedto the regulation of �re-retardant chemicalsPetition: No. 262

Issue(s): Human health/environmental health, and toxic substances

Petitioner(s): Mary Lou McDonald

Date Received: 16 July 2008

Status: Completed

Summary: The petitioner is concerned that the assessment criteria in the Persistence andBioaccumulation Regulations do not adequately measure the bioaccumulation effects of certain fire-retardant chemicals, such as decabromodiphenyl ether (decaBDE). The petitioner asks the federalgovernment to modify the regulations to test exposure through water, food, and air. The petitioner alsorequests that the federal government recommend a ban on decaBDE under the Canadian EnvironmentalProtection Act, 1999, since the petitioner alleges that it has already been demonstrated that decaBDE ispersistent, toxic, and bioaccumulative.

Federal Departments Responsible for Reply: Environment Canada, Health Canada

PetitionJuly 15, 2008

Auditor General of Canada 240 Sparks Street

Ottawa, ON K1A 0G6

Re: Petition Requesting a Ban of DecaBDE and a Change to the Bioaccumulation Regulations 

Personal Background:

My name is Mary Lou McDonald, and I have a concern with the final regulations published on July 9, 2008relating to Polybrominated Diphenyl Ethers (“PBDEs”). July 9, 2008 is two years to the day when myfather, Robert C. McDonald, died from ALS, a horrible degenerative disease that takes its victims quickly.Dad fought hard, and one of his steps was to eliminate all toxins from his environment. The reason he didthis is because ALS is a condition of “good cells gone bad”: the good cells attack a bad substance then keepon going and attack the body, so the idea is to eliminate all exposure to bad substances. In the end, he wasconvinced that something in the institutional lift chair that was brought into the house accelerated his

decline. Four days before he died, I promised him that I would look into it and try to make a difference. By

Office of the Auditor General of Canada (/internet/English/admin_e_41.html)

decline. Four days before he died, I promised him that I would look into it and try to make a difference. Bythat time, the disease had taken his speech, but not his inner strength, and his response was to gesture asstrongly as he could with his head and eyes that I should do that.

So I started looking into it, and my investigations led to PBDEs. I could not believe the extent to whichPBDEs are everywhere, and we don’t even know about them or know that they are all around us in oureveryday lives. Like Dad didn’t know that there was anything in his chair. I, like Dad, thought we were safeif we did not eat bad things or expose ourselves to sources of pollution like factories. I did not realize thatwe are exposed to dangerous chemicals in items around us every day: furniture, rugs, beds, drapes,clothing, and (I emphasize the next ones) our computers, TVs and cars. This realization had two effects.

First E�fect:

First, this realization made me angry. I educated myself and read everything I could on PBDEs. I learnedthat they are used as fire retardants, and that the bromine (a fire retardant) industry is opposed to banningPBDEs, for obvious reasons. However firefighters are joining the fight against PBDEs because too many ofthem are dying from exposure to the corrosive gas released when PBDEs burn. I learned that there arethree commercial mixtures of PBDEs, known and PentaBDE, OctaBDE and DecaBDE. Most jurisdictionsare agreed that the first two are toxic and have banned them, and more and more jurisdictions (likeSweden, Maine and Washington) are moving against DecaBDE.

When I looked into the commercial mixture DecaBDE more (also known as BDE-209), I learned that it ismade up almost entirely of the chemical known as “small d” decaBDE. It is used to add fire retardantcapability to hard plastics, such as those used in the items in our personal space everyday like cars,computers, and TVs. I learned that it debrominates or breaks down when exposed to sunlight into bannedchemicals, and that this debromination has even been acknowledged by Environment Canada. Because it isin our TVs, computers and cars, it is being found in alarming concentrations in household and office dustand on car windshields, and small children receive up to 300 times more exposure than adults fromhousehold dust and breastmilk. Some studies have described a “personal cloud effect” of DecaBDE,meaning there is more DecaBDE in “personal air” than in general area air. Yet more than 22 millionkilograms of DecaBDE are built into consumer products in North America in a year.

I also learned there are inexpensive, alternative ways to retard fire other than using DecaBDE. Substitutesubstances, design changes and different technologies can all be used, and for no extra cost in most cases,and for a marginal price increase in other cases. For example, hard television enclosures can be made fromalternative resins combined with fire retardants other than DecaBDE, and a shift to such other resinswould result in only a small increase in the price of low-end televisions. For every car component thatuses DecaBDE, there is an alternative on the market. The fact that alternatives are available and notexpensive did not appease my anger, as you can appreciate.

Second E�fect:

The second effect of the realization that PBDEs are all around us was to ask what the government is doingabout it. So I looked into it and saw that the federal government had proposed regulations on PBDEs onDecember 16, 2006 and have now published, on July 9, 2008 (as indicated), the final PBDE regulations (the“New Regulations”). I applaud the government for the New Regulations insofar as they ban the first twocommercial mixtures of PBDEs, PentaBDE ad OctaBDE.

But the government has not gone far enough because it has not banned DecaBDE. The press releaseannouncing the New Regulations, however, did indicate that Environment Canada is performing “adetailed review of the newly published science on DecaBDE, to determine if there is a need for further

controls on the DecaBDE commercial mixture”. Environment Canada has reviewed newly published

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controls on the DecaBDE commercial mixture”. Environment Canada has reviewed newly publishedscience, (post-2005) on decaBDE and has prepared a draft report. “When finalised, the Report will assistthe Minister with his decision on whether to establish a Board of Review, and whether further controls ondecaBDE are required.”

Purpose of the Petition

The purpose of this petition is to ask the Minister of the Environment to take the extra step andrecommend banning decaBDE. The reason is that the new science is clearly indicating that decaBDEbioaccumulates in air-breathing organisms. This has been “confirmed unambiguously” with respect toterrestrial top predators, such as the red fox. Data obtained from addled eggs of peregrine falcons andother raptors in the United States and China and from polar bears provide supporting evidence for thisconclusion, as do numerous other studies.

Which begs the question: If decaBDE bioaccumulates, why was it not caught by the screening forbioaccumulation under the Canadian Environmental Protection Act? I have looked into this question, and theanswer is that the criteria set out in the Persistence and Bioaccumulation Regulations (the “BioaccumulationRegs”) are faulty, because they let some substances fall through the cracks. One such substance is decaBDE.So I also petition the government to change the screening tests in the Bioaccumulation Regs or change theway they are applied so that all substances are caught.

The rest of this document will explain how it is that the Bioaccumulation Regs fall short of the mark andshould be changed.

Regulatory Criteria Fail to Detect Bioaccumulation of Some Substances

The government in its Toxic Substances Management Policy – Persistence and Bioaccumulation Criteriaemploys the definition of bioaccumulation as “a general term describing a process by which substances areaccumulated by organisms directly from the surrounding media and through consumption of foodcontaining the substances”

Environment Canada in its web glossary describes bioaccumulation as “substances that are stored in livingtissues (including people), and remain for very long periods of time, during which concentrations canreach very high levels. These substances can also be transferred up the food chain.” This transfer up thefood chain is also called biomagnification.

The regulatory criteria for determining bioaccumulation as set out in the Bioaccumulation Regs arebioaccumulation factor (“BAF”), bioconcentration factor (“BCF”) and logarithm of the substance's octanol-water partition coefficient (“K ”). The BAF and BCF both measure the accumulation of the substancefrom surrounding media, and the BAF also includes the uptake of chemical from food. The K is anestimation of a substance’s hydrophobicity or lipophilicity and its tendency to partition into organic andbiological matrices from water.

However the Bioaccumulation Regs are “water biased” (my term). The Bioaccumulation Regs define theBAF as: “the ratio of the concentration of a substance in an organism to the concentration in water, based onuptake from the surrounding medium and food”. The BCF is defined as “the ratio of the concentration of asubstance in an organism to the concentration in water, based on uptake from the surrounding medium”. TheK is defined as the ratio of the concentration of a substance in an octanol phase to the concentration of thesubstance in the water phase of an octanol-water mixture.

The Bioaccumulation Regs outline the endpoint values and processes for determining bioaccumulation in

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The Bioaccumulation Regs outline the endpoint values and processes for determining bioaccumulation inSection 4. The endpoint values for the criteria are:

(a) when its BAF is equal to or greater than 5 000;

(b) if its BAF cannot be determined in accordance with a method referred to in section 5, when itsBCF is equal to or greater than 5 000; and

(c) if neither its BAF nor its BCF can be determined in accordance with a method referred to insection 5, when the K is equal to or greater than 100,000 (or logarithm K  ³ 5).

The method referred to in section 5 is the generally recognized methods of the Organisation for EconomicCo-operation and Development (“OECD”) or of some other similar organisation or, if no such methodsexists, in accordance with generally recognized methods within the scientific community and taking intoaccount the intrinsic properties of the substance, the ecosystem under consideration and the conditions inthe environment.

What is interesting is that decaBDE meets the log K tests set out in the Bioaccumulation Regs.Environment Canada estimates the log K for BDE-209 is in the range of 6.27 to 9.97, which is greaterthan the regulated log K of decaBDE > 5. This means to me that the testers were of the view thatdecaBDE did not pass either the BAF or the BCF tests of the Bioaccumulation Regs.

One reason that decaBDE would not have passed either the BAF or the BCF tests of the BioaccumulationRegs is that these tests are “water-biased”: they are based on the concentrations of chemicals in water, andsuch water tests don’t work for chemicals like decaBDE. The Bioaccumulation Regs, in comparing theconcentration of the substance in the organism to the concentration in water, assume that theconcentration in water is relevant vis-à-vis the concentration in the organism. However, theconcentration of the substance in the organism may not be related to the concentration of the substance inwater, as, for example, is the case for organisms that respire air such as birds and mammals, includinghumans. As such, the Bioaccumulation Regs fail to detect substances that are taken up from thesurrounding media that are not directly based to an aquatic environment (e.g., fish). A chemical propertythat does reflect bioaccumulation potential for air respiring organisms is the octanol-air partitioncoefficient (“K ”).

The literature has indicated that bioaccumulation (in the form of biomagnification) of certain substances isoccurring in air-breathing terrestrial and marine organisms by virtue of the high K of the substancesand low rate of respiratory elimination from air-breathing animals. A summary of one article is below.

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“Substances that accumulate to hazardous levels in living organisms pose environmental andhuman-health risks, which governments seek to reduce or eliminate. Regulatory authoritiesidentify bioaccumulative substances as hydrophobic, fat-soluble chemicals having high octanol-water partition coefficients (K ) (³ 100,000). Here we show that poorly metabolizable,moderately hydrophobic substances with a K between 100 and 100,000, which do notbiomagnify (that is, increase in chemical concentrations in organisms with increasing trophiclevel) in aquatic food webs, can biomagnify to a high degree in food webs containing air-breathinganimals (including humans) because of their high octanol-air partition coefficient (K ) andcorresponding low rate of respiratory elimination to air. These low K - high K chemicals,representing a third of organic chemicals in commercial use, constitute an unidentified class ofpotentially bioaccumulative substances that require regulatory assessment to prevent possibleecosystem and human-health consequences.”

A recent review of BCF and BAF assessments for chemicals in aquatic organisms makes the same pointthat criteria derived only for water-respiring organisms do not adequately measure bioaccumulation interrestrial beings:

“Bioaccumulation regulations need to consider organisms other than aquatic species for hazardand risk assessment. All current criteria are based on endpoints obtained from aquatic specieswhile many deleterious effects attributable to high levels of bioaccumulation are observed in non-aquatic organisms (e.g., birds, mammals). For chemicals with low K but high K , aquaticorganisms have a greater capacity for elimination of these chemicals than air breathing organisms.Such chemicals have been observed to biomagnify in terrestrial food webs while showing nobioaccumulation in aquatic food webs (Kelly and Gobas 2001, 2003; Czub and McLachlan 2004).In absence of metabolic biotransformation, approximately 40% of commercial chemicals that donot biomagnify in aquatic systems have the potential to biomagnify in terrestrial food webs(Gobas et al. 2003). While some of the aquatic based criteria may be able to indirectly identifybioaccumulative hazards to non-aquatic species, current criteria do not explicitly account for theseinherent differences between aquatic and terrestrial organisms.”

As indicated, decaBDE bioaccumulates in air-breathing organisms. DecaBDE has also been determined tohave low water solubility. Because DecaBDE bioaccumulates in air-breathing terrestrial organisms andhas very low water solubility, bioaccumulation assessments on decaBDE in relation to water are not useful.Bioaccumulation assessments made in relation to water are letting some chemicals fall through the cracks.

The possibility that the criteria set out in the Bioaccumulation Regs may not always prove adequate wasrecognized in the 1995 document that formed the basis for the criteria, the Toxic Substances ManagementPolicy: Persistence and Bioaccumulation Criteria. The authors, the ad hoc Science Group on Criteria, thereinstated: “In the future, with scientific progress in our understanding of persistence of bioaccumulationprocesses and methodological developments, there may be a need to revise both the criteria and the criticalvalues”. Science has progressed to the point where these revisions need to be made.

Request for Tests and Approaches that Better Re�lect Bioaccumulation Potential

It is my understanding, although I am by no means a scientist, that various other tests and approaches

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It is my understanding, although I am by no means a scientist, that various other tests and approachescould be used that might better reflect bioaccumulation potential. Based on the studies presented above, itappears that augmenting the bioaccumulation criteria with the K would be beneficial. Testing couldoccur through exposure through water, diet and air respiration, depending on the type of substance. Alsoallowing for a less rigid endpoint determination standard might be useful. That is, rather than having acut-off point of 5 000 for BAF and BCF, perhaps a range could be employed while factoring in otherevidence. Bioaccumulation modelling approaches could also be explicitly allowed, as could other modellingapproaches that consider bioaccumulation, persistence and toxicity from a more holistic, generalizedperspective in the context of risk.

For example, modelling has correctly shown that DecaBDE bioaccumulates. The authors of the articlementioned above who point out that some substances are not caught by current regulatory criteria usedmodelling to demonstrate the biomagnification of chemicals exhibiting characteristics of low K - lowK , low K - high K and finally high K - high K . The article included modelling for PBDE209, which is the commercial mixture that contains 98 to 99% decaBDE. It found that PBDE 209 was of the“high K - high K ” category, in that it had a log K of 9.9 and a log K of 13.1. It also found thatthe biomagnification factor for decaBDE in terrestrial carnivores and humans was 8, which is greaterthan the recognized biomagnification factor hazard indicator of 1. Based on this model, decaBDEbioaccumulates in humans and terrestrial carnivores.

Petition

Based on the above:

a. I petition the Ministers of Health and the Environment to recommend a ban on decaBDE underCEPA because it is bioaccumulative, and has already been shown to be persistent and toxic.

If they do not, then I petition them to specifically answer these questions:

a. what is their response to the fact that the new science indicates and it has been “confirmedunambiguosly” that decaBDE bioaccumulates in certain top predators;

b. what is their response to my point that bioaccumulation tests that are “water-biased” do notadequately test all substances including decaBDE;

c. what is their response to the following position: since bioaccumulation tests based on waterdo not adequately test for bioaccumulation of some substances taken in by air-respiringspecies (such as decaBDE), and since the BAF and BCF tests as defined in theBioaccumulation Regs are based on water, then the BAF and BCF tests as set out in theBioaccumulation Regs can never determine the bioaccumulation potential of certainsubstances?

b. I petition the Ministers of Health and the Environment to recommend a change to theBioaccumulation Regs to employ additional criteria that recognize uptake of a substance throughmedia other than water and species other than aquatic species; to test through exposure to water,food and air; to employ less strict endpoint values and methods; and to recognize other methods fordetermining bioaccumulation such as modelling.

If they do not, then I petition them to:

a. advise on the steps they will take to ensure that no substances fall through the cracks in

bioaccumulation assessments; and

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bioaccumulation assessments; andb. apply the Bioaccumulation Regs to decaBDE as they are written. The Bioaccumulation Regs state

that if neither the BAF nor the BCF of a substance can be determined in accordance with areferenced method, then the test is met when logarithm K  ³ 5. Since it is the case, as indicatedin 1(c) above, that the BAF and BCF tests as set out in the Bioaccumulation Regs can neverdetermine the bioaccumulation potential of certain substances, simply by virtue of the fact that thetests are defined in relation to water, then recourse is had, as required by the actual wording of theBioaccumulation Regs, to the log K test. DecaBDE meets the log K test.

Closing

Thank you for considering this petition. Please help me keep my promise to my Dad: both to honour hismemory and also for the sake of all the other Canadians who are exposed to persistent, toxic andbioaccumulative substances like decaBDE in their everyday lives.

Sincerely,

[Original signed by Mary Lou McDonald]

Mary Lou McDonald c/o 2845 Bristol Circle Oakville, ON L6H 5L7

 Maine Department of Environment Protection and Maine Centre for Disease Control and Prevention.2007, Brominated Flame-retardants: Third annual report to the Maine Legislature, January 2007 at 35.

 Environment Canada New Release, “Government of Canada Bans More Harmful Chemicals More ActionTaken Under Chemicals Management Plan , Ottawa, July 11, 2008.   Environment Canada, Regulatory Impact Analysis Statement, Ottawa, July 9, 2008.

  47 Voorspoels, S. et al 2006. Remarkable Findings Concerning PBDEs in the Terrestrial Top-PredatorRed Fox (VulpesVulpes). Environ. Sci. Tech. 40. 2937-2943).

   Environment Canada Toxic Substances Management Policy: Persistence and Bioaccumulation Criteria,June 1995 Ottawa Final Report of the ad hoc Science Group on Criteria p. 13

 Environment Canada. Toxic Substances Management Policy – Persistence and Bioaccumulation Criteria. (June1995) at 18.

Environment Canada. 2006. Canadian Environmental Protection Act, 1999 Ecological ScreeningAssessment Report on Polybrominated Diphenyl Ethers (PBDEs). p. 5.

B. Kelly et al, ‘Food-Web Specific Biomagnification of Persistent Organic Pollutants’, 317 Science(13 July 2007) 236, at 236.

 J. Arnot and F. Gobas, ‘A Review of Bioconcentration Factor (BCF) and Bioaccumulation Factor (BAF)Assessments for Organic Chemicals in Aquatic Organisms’, 14 Environ. Rev. (2006), 257, at 292.

Per Ola Darnerud, Gunnar S. Eriksen, Torkell Jóhannesson, Poul B. Larsen, and Matti Viluksela. 2001.

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Per Ola Darnerud, Gunnar S. Eriksen, Torkell Jóhannesson, Poul B. Larsen, and Matti Viluksela. 2001.Polybrominated Diphenyl Ethers: Occurrence, Dietary Exposure, and Toxicology. Environmental HealthPerspective Supplement. Vol 109, 49 at 49, 50.

Environment Canada Toxic Substances Management Policy: Persistence and Bioaccumulation Criteria,June 1995 Ottawa Final Report of the ad hoc Science Group on Criteria p. 13

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Joint Response: Environment Canada, Health Canada11 November 2008

Ms. Mary Lou McDonald 2845 Bristol Circle Oakville, Ontario L6H 5L7

Dear Ms. McDonald:

I am pleased to provide Environment Canada’s and Health Canada’s joint response to your EnvironmentalPetition No. 262, to the Commissioner of the Environment and Sustainable Development, requesting aban on decabromodiphenyl ether (decaBDE) and requesting changes to the Persistence and BioaccumulationRegulations of the Canadian Environmental Protection Act, 1999. Your petition was received in the Departmenton July 18.

Please find enclosed a joint response from Environment Canada and Health Canada to questions that fallwithin the mandates of each of the departments.

I appreciate this opportunity to respond to your petition and trust that you will find this informationuseful.

Sincerely,

[Original signed by Jim Prentice, Minister of the Environment]

The Honourable Jim Prentice, P.C., Q.C., M.P.

Enclosure

c.c.: The Honourable Leona Aglukkaq, P.C., M.P. Mr. Scott Vaughan, Commissioner of the Environment and Sustainable Development 

11 November 2008

Ms. Mary Lou McDonald c/o 2845 Bristol Circle Oakville, Ontario L6H 5L7

Dear Ms. McDonald:

This is in response to your environmental petition No. 262 of July 16, 2008, addressed to the

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This is in response to your environmental petition No. 262 of July 16, 2008, addressed to theCommissioner of the Environment and Sustainable Development.

In your petition you raised concerns about the use of decabromodiphenyl ether (decaBDE).

Due to the nature of the questions being raised in the petition, Health Canada has collaborated withEnvironment Canada to prepare a joint response. My colleague, the Honourable John Baird, Minister ofthe Environment, will be providing you with the Government of Canada response to the petition. Thisresponse has been reviewed by my officials, who are in concurrence with its conclusions.

I appreciate your interest in this important matter, and I hope that you will find the information useful.

Yours sincerely,

[Original signed by Leona Aglukkaq, Minister of Health]

Leona Aglukkaq

c.c.: Mr. Scott Vaughan, CESD The Honourable Jim Prentice, P.C., M.P. 

Environment Canada’s and Health Canada’s Response to Environmental Petition No. 262, pursuant to section 22 of the Auditor General Act, requesting a

ban on decabromodiphenyl ether (decaBDE) and requesting changes to the Persistence andBioaccumulation Regulations of the Canadian Environmental Protection Act, 1999

(a) I petition the Ministers of Health and the Environment to recommend a ban on decaBDE under CEPA because itis bioaccumulative, and has already been shown to be persistent and toxic.

On July 1, 2006, the Government of Canada published its final screening assessment of polybrominateddiphenyl ethers (PBDEs) (see reference 1). The human health risk assessment concluded that worst‑caseestimates of the exposure of Canadians to PBDEs were much lower than the levels of exposure whichcaused health effects in laboratory animals. The environmental risk assessment concluded that PBDEs (i.e.,tetrabromodiphenyl ether [tetraBDE], pentabromodiphenyl ether [pentaBDE], hexabromodiphenyl ether[hexaBDE], heptabromodiphenyl ether [heptaBDE], octabromodiphenyl ether [octaBDE],nonabromodiphenyl ether [nonaBDE] and decabromodiphenyl ether [decaBDE]), which are found incommercial PentaBDE, OctaBDE and DecaBDE technical formulations, are entering the environment in aquantity or concentration or under conditions that have or may have an immediate or long‑term harmfuleffect on the environment or its biological diversity. Therefore, PBDEs meet the criteria under paragraph64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In addition, it was concluded that allPBDEs assessed met the criteria for persistence, but only tetra- to hexaBDEs met the criteria forbioaccumulation as defined in the Persistence and Bioaccumulation Regulations under CEPA 1999. Theanalysis also noted that the higher brominated diphenyl ethers, and decaBDE in particular, couldaccumulate to some degree in biota and debrominate to bioaccumulative and persistent transformationproducts.

The environmental component of the PBDE screening assessment considered information obtained as ofOctober 2004 (see references 1 and 7). Although information received between November 2004 andOctober 2005 was reviewed, it was generally not added to the assessment because these studies supported

the conclusions of the draft assessment published for public comment in 2004. Since 2004, a large amount

the conclusions of the draft assessment published for public comment in 2004. Since 2004, a large amountof information has been published, notably on the issues of decaBDE bioaccumulation and transformation.

In order to understand the wealth of new information on decaBDE published during and after 2004,Environment Canada has prepared a draft State of Science Report on the Bioaccumulation andTransformation of Decabromodiphenyl Ether that examines the current science respecting thebioaccumulation and transformation of decaBDE in the environment. This report also considers the newdata to determine whether these show that the bioaccumulation criteria as identified in the Regulationsunder CEPA 1999 are met for this substance. The draft Report has recently undergone a peer review byexternal science experts from international and Canadian governments, academia, non‑governmentalenvironmental groups and industry. It will be published later this fall for a 60‑day public comment periodon the CEPA Environmental Registry website (www.ec.gc.ca/CEPARegistry/participation), and a summarywill be published in the Canada Gazette publication (http://canadagazette.gc.ca). An announcementrespecting its availability for public comment will also occur through the federal government’s CanadianChemical Substances Portal (www.chemicalsubstanceschimiques.gc.ca/en). During the public commentperiod, you can review this report and submit any comments you may have respecting its contents. Thisreview will be used to determine whether further controls on the decaBDE commercial mixture arewarranted.

The final Polybrominated Diphenyl Ethers Regulations were published in the Canada Gazette, Part II, onJuly 9, 2008. The purpose of the Regulations is to protect Canada’s environment from the risks associatedwith PBDEs by preventing their manufacture and restricting their use in Canada, therefore minimizingtheir releases into the environment. These regulations represent an important first step in the riskmanagement of PBDEs in Canada, with a focus on those PBDEs of greatest concern. To complement theRegulations, several other risk management measures are currently being developed, including: aregulation to address PBDEs in manufactured products, a voluntary approach to minimize releases into theenvironment from the use of the DecaBDE commercial mixture in Canadian manufacturing operations, adetailed review of recently published science on decaBDE (as noted above), and monitoring Canadians’exposure to PBDEs and concentrations in the environment. More details are outlined in the revised RiskManagement Strategy for PBDEs (www.ec.gc.ca/TOXICS/EN/detail.cfm?par_substanceID=201&par_actn=s1).

If they do not, then I petition them to speci�ically answer these questions:

a. what is their response to the fact that the new science indicates and it has been “con�irmed unambiguously” thatdecaBDE bioaccumulates in certain top predators;

The draft State of Science Report on the Bioaccumulation and Transformation of DecabromodiphenylEther provides a detailed evaluation of decaBDE bioaccumulation for water ‑ and air‑breathingorganisms. The evaluation identifies and reviews many studies showing detected concentrations ofdecaBDE in a wide range of terrestrial and aquatic biota, including top predators. This analysis confirmsthat decaBDE can accumulate in organisms and echoes your concern that decaBDE may accumulate inwildlife to potentially high concentrations. Elevated levels (e.g., exceeding 100 nanograms per gram [ng/g]lipid) of decaBDE have been measured in the tissues of several top predators, including:

Birds of prey, especially Kestrels, Sparrowhawks and Owls in China; Buzzards, Peregrine Falcons,Sparrowhawks and Kestrels (tissues and/or eggs) in Europe; and Peregrine Falcon eggs inGreenland (see references 4, 9, 10, 15 and 21).Red fox in Belgium (see reference 13).

Sharks of coastal Florida (see reference 11).

Sharks of coastal Florida (see reference 11).Marine mammals, such as harbor seals and whitebeaked dolphins (see reference 16).

In addition, research shows that in some species the decaBDE tissue concentrations are increasing rapidly.Based on sampling conducted of Herring Gull (Larus argentatus) eggs from the Great Lakes basin, a meandoubling time for decaBDE concentrations in eggs has been determined to be 2.1 to 3 years (seereference 8). As well, many other studies describe some accumulation in terrestrial organisms, such aspolar bears.

It should be noted that studies showing accumulation, even to high levels, may not support that asubstance is meeting criteria for bioaccumulation as identified in the Persistence and BioaccumulationRegulations. This may be because studies do not compare measured decaBDE concentrations in tissues withthose determined in the environment and/or consumed food, so these studies do not provide theappropriate numerical evidence to determine whether or not decaBDE may be bioaccumulative as definedunder CEPA 1999.

As well, elevated concentrations in biota may reflect localized areas of high decaBDE concentrations. Ifenvironmental concentrations are sufficiently high, biota concentrations may also become very high inequilibrium with their surrounding environment and food, although quantified bioaccumulation factors(BAFs), biomagnification factors (BMFs) or bioconcentration factors (BCFs) may be very low. There arenow a variety of field studies which estimate BMFs. These are reviewed in the State of Science Report.The Report also describes the results of bioaccumulation and biomagnification modelling for decaBDEwith consideration given to the substance’s log n-octanol-water partition coefficient (K ), log n-octanol-air partition coefficient (K ), and rates of metabolic transformation shown in the literature for decaBDE.

Based on their study of decaBDE concentrations in the tissues of red fox from Belgium, Voorspoels et al.(see reference 13) are quoted as saying that new science has “confirmed unambiguously” that decaBDEbioaccumulates in top predators. In their study, decaBDE was detected in less than half of the tissuesamples, with concentrations (ng/g lipid) that ranged from less than 9.1 to 760 for liver, from less than 3.9to 290 in muscle, and from less than 3.7 to 200 for adipose tissue. However, in a follow‑up paper byVoorspoels et al. (see reference 14), decaBDE was not detected in the main prey species of red fox. Forthis study, whether biomagnification or bioaccumulation was taking place could not be established.However, the fact that decaBDE is accumulating in wildlife, sometimes rapidly and sometimes to highlevels, is problematic and a potential ecological concern. Further information on studies examining thebioaccumulation potential of decaBDE will be available in the State of Science Report on theBioaccumulation and Transformation of Decabromodiphenyl Ether.

b. what is their response to my point that bioaccumulation tests that are “water-biased” do not adequately test allsubstances including decaBDE;

The available science indicates that decaBDE is a very hydrophobic substance. For example, an industrystudy determined that the limit of water solubility for decaBDE was less than 0.1 micrograms per litre(µg/L) at 25 degrees Celsius (see reference 12). The available predicted estimates (using QuantitativeStructure Activity Models or QSARs) for decaBDE indicate that its solubility may be in the range of 2.84 x10-8 to 2.61 x 10-4 µg/L at 25 degrees Celsius (see reference 7). Given the exceptionally low watersolubility limit of decaBDE, it is not expected that this substance will be appreciably taken up by aquaticorganisms from the water phase. Therefore, water‑based studies have limited utility when assessing thebioaccumulation potential of substances with extremely low levels of water solubility. One would,however, expect to find decaBDE adsorbed to organic solid materials, including sediments and itemsconsumed in diet. As such, studies that evaluate the uptake and accumulation of chemical substances from

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consumed in diet. As such, studies that evaluate the uptake and accumulation of chemical substances fromsediments and/or soils and diet which measure bioaccumulation and biomagnification factors have greaterrelevance for the bioaccumulation assessment of highly hydrophobic substances like decaBDE.

c. what is their response to the following position: since bioaccumulation tests based on water do not adequately testfor bioaccumulation of some substances taken in by air‑respiring species (such as decaBDE), and since the BAF andBCF tests de�ined in the Bioaccumulation Regs are based on water, then the BAF and BCF tests set out in theBioaccumultion Regs can never determine the bioaccumulation potential of certain substances?

The current bioaccumulation criteria identified in the Persistence and Bioaccumulation Regulations weredeveloped from the science of chemical bioaccumulation in fish and are mainly applicable towater‑breathing organisms. As the science of bioaccumulation has progressed, researchers havedemonstrated the usefulness of a variety of other measures for establishing whether food webbiomagnification is occurring. Additional measures of bioaccumulation that can also be used to address thepotential for chemicals to biomagnify in food webs include BMFs, trophic magnification factors (TMFs,sometimes referred to as food‑web biomagnification factors), biota sediment application factors (BSAFs),and soil BAFs. However, these alternative measures are not relevant to the criteria identified in theRegulations, which are focused on aquatic BCF and BAF measures.

In particular, for terrestrial and aquatic/marine birds and mammals, air inhalation and diet are importantsources of chemical uptake as you noted in your petition. While partitioning based on the K is the mainchemical property affecting chemical uptake and elimination of neutral organics in aquaticwater‑breathers, this is not the case for air‑breathers. Organism–air exchange involves lipid–airpartitioning and is expected to depend on K . K provides an indication of the tendency of a chemical toaccumulate in the tissues of air‑breathing organisms.

Although the Persistence and Bioaccumulation Regulations under CEPA 1999 do not explicitly refer tomeasures of BMF, TMF or BSAF and do not refer to measures like K , concerns of very bioaccumulativesubstances, including those which biomagnify, are captured by the Toxic Substances Management Policy(see references 2 and 3). Developed during the early 1990s, the purpose of the Policy is to manage verybioaccumulative substances and substances which biomagnify regardless of whether the organisms areaquatic or terrestrial. Criteria in the Regulations are based on those in the Policy that guide theGovernment of Canada in determining whether substances should be identified for virtual elimination, orlife cycle management. In keeping with this policy, actions may be taken to control substances which areshown to biomagnify, or accumulate from sources other than those which are aquatic based. This policyalso provides latitude for the federal government to take action on a substance should it be shown totransform in the environment to forms which are bioaccumulative.

(b) I petition the Ministers of Health and the Environment to recommend a change to the Bioaccumulation Regs toemploy additional criteria that recognize uptake of a substance through media other than water and species otherthan aquatic species; to test through exposure to water, food and air; to employ less strict endpoint values andmethods; and to recognize other methods for determining bioaccumulation such as modelling.

As mentioned previously, criteria in the Regulations under CEPA 1999 are based on those in the ToxicSubstances Management Policy. Given advancements in the state of the science on persistent organicpollutants (POPs) since that time, as well as changes in domestic and international policy surroundingPOPs, Environment Canada is considering revisions to the Persistence and Bioaccumulation Regulations. Sucha revision would support appropriate decision making in the development of measures for the largenumber of substances entering the risk management phase under the Chemicals Management Plan. These

discussions would give consideration to other measures which recognize uptake of a substance through

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discussions would give consideration to other measures which recognize uptake of a substance throughmedia other than water (e.g., through air and diet) and organisms who breathe air, rather than water; aswell as to other methods like modelling.

If they do not, then I petition them to:

a. advise on the step they will take to ensure that no substances fall through the cracks in bioaccumulationassessments; and

Through a potential review of the Persistence and Bioaccumulation Regulations, it is expected that theresultant revisions, if any, would support the development of measures that are appropriatelycomprehensive and based on science, to manage substances which may be highly bioaccumulative and/orbiomagnify in air‑ and water‑breathing organisms.

b. apply the Bioaccumulation Regs to decaBDE as they are written. The Bioaccumulation Regs state that if neither theBAF nor the BCF of a substance can be determined in accordance with a referenced method, then the test is met whenlogarithm K ≥ 5. Since it is the case, as indicated in 1(c) above, that the BAF and BCF tests as set out in theBioaccumulation Regs can never determine the bioaccumulation potential of certain substances, simply by virtue ofthe fact that the tests are de�ined in relation to water, then recourse is had, as required by the actual wording tin theBioaccumulation Regs, to the log K  test. DecaBDE meets the log K  test.

As noted previously, Environment Canada has completed a draft State of Science Report that reviews theavailable studies pertaining to the bioaccumulation and transformation of decaBDE. This report will bepublished in the Canada Gazette for a 60‑day public comment period this autumn. This review considersboth measured and predicted BAFs and BCFs, and considers whether the criteria for bioaccumulation asidentified under the Persistence and Bioaccumulation Regulations under CEPA 1999 are met.

You are correct when you note the Regulations indicate that if neither its bioaccumulation factor nor itsbioconcentration factor can be determined in accordance with a method referred to in section 5 then thetest is net, when the logarithm of its octanol‑water partition coefficient is equal to or greater than 5.However, it should be noted that section 5 of the Regulations goes on to indicate that “the determinationof persistence and bioaccumulation…must be made…taking into account the intrinsic properties of thesubstance, the ecosystem under consideration and the conditions in the environment.”

The Regulations thus require that professional judgment be applied through the consideration of aparticular substance’s intrinsic properties and ecosystem under consideration. While the log K is awell‑known indicator of bioaccumulation for some substances, its application requires substantialscientific judgment due to various inherent limitations when used for this purpose. This approach isconsistent with guidance identified in the Toxic Substances Management Policy (see references 2 and 3)which provides discussion of the uncertainties relating to the use of K for making conclusions onbioaccumulation. In particular, an organism’s ability to metabolize a substance can dramatically decrease itsbioaccumulation potential.

Neither BCF nor BAF with measured values in excess of 5 000 are available for decaBDE, and while thepossible range of log K for this substance exceeds the respective criteria for bioaccumulation in thePersistence and Bioaccumulation Regulations, the use of this data is considered inappropriate. The State ofScience Report found that a variety of studies show that both mammals and fish have the ability to likelymetabolize decaBDE (see references 5, 6 and 17–20). This process is an important factor in understanding

the bioaccumulation potential of decaBDE and has been incorportated into the Report’s modeling

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the bioaccumulation potential of decaBDE and has been incorportated into the Report’s modelingestimates for decaBDE BAF and BMF. In addition, as noted previously, log K values for substances withextremely low water solubility are highly uncertain.

As a result of the uncertainties associated with the log K value for decaBDE and the capabilitydemonstrated by organisms to metabolize this substance, the use of log K as an indicator ofbioaccumulation is not scientifically appropriate for use in this case.

References

1)  Canada 2006. Canadian Environmental Protection Act, 1999 - Ecological Screening Assessment Report onPolybrominated Diphenyl Ethers (PBDEs). 

2) Canada 1995a. Toxic Substances Management Policy. Government of Canada, Environment Canada.Minister of Supply and Services Canada. Catalogue No. En 40-499/1-1995, ISBN 0-662-61860-2.

3) Canada 1995b. Toxic Substances Management Policy: Persistence and Bioaccumulation Criteria. Governmentof Canada, Environment Canada. Minister of Supply and Services Canada. Catologue No. En 40-499/2-1995, ISBN 0-662-23524-X.

4) D. Chen, B. Mai, J. Song, Q. Sun, Y. Luo, X. Luo, E.Y. Zeng and R.C. Hale. 2007. “Polybrominateddiphenyl ethers in birds of prey from Northern China.” Environmental Science & Technology, Volume41(6), pages 1828 to 1833.

5) J.K. Huwe and D.J. Smith. 2007. “Accumulation, whole-body depletion, and debromination ofdecabromodiphenyl ether in male Sprague-Dawley rats following dietary exposure.” EnvironmentalScience & Technology, Volume 41(7), pages 2371-2377.

6) J.K. Huwe and D.J. Smith. 2007. “Accumulation, whole-body depletion, and debromination ofdecabromodiphenyl ether in male Sprague-Dawley rats following dietary exposure. Additions andCorrections.” Environmental Science & Technology, Volume 41(12), pages 4486.

7) Environment Canada 2006. Canadian Environmental Protection Act Supporting Working Document forthe Environmental Screening Assessment of Polybrominated Diphenyl Ethers.

8) L.T. Gauthier, C.E. Hebert, C.D.V. Weseloh, and R.J. Letcher. 2008. “Dramatic changes in thetemporal trends of polybrominated diphenyl ethers (PBDEs) in Herring Gull eggs from the LaurentianGreat Lakes: 1982–2006.” Environmental Science & Technology, Volume 42(5), pages 1524 to 1530.

9) P. Lindberg, U. Sellström, L. Häggberg and C. A. de Wit. 2004. “Higher brominated diphenyl ethersand hexabromocyclododecane found in eggs of Peregrine Falcons (Falco peregrinus) breeding inSweden.” Environmental Science & Technology, Volume 38(1), pages 93 to 96.

10)V.L. Jaspers, A. Covaci, S. Voorspoels, T. Dauwe, M. Eens and P. Schepens. 2006. “Brominated flameretardants and organochlorine pollutants in aquatic and terrestrial predatory birds of Belgium: levels,patterns, tissue distribution and condition factors.” Environmental Pollution, Volume 139, pages 340 to352.

11)B. Johnson-Restrepo, K. Kannan, R. Addink and D.H. Adams. 2005. “Polybrominated diphenyl ethersand polychlorinated biphenyls in a marine foodweb of Coastal Florida.” Environmental Science &Technology, Volume 39, pages 8243 to 8250.

12)Chemical Manufacturers Association Brominated Flame Retardant Industry Panel (CMABFRIP). 1997.“Decabromodiphenyl oxide (DBDPO): determination of n-octanol/water partition coefficient.”Wildlife International Ltd., Project Number 439C-101, June 16, 1997.

13)S. Voorspoels, A. Covaci, P. Lepom, S. Escutenaire and P. Schepens. 2006. “Remarkable findingsconcerning PBDEs in the terrestrial top‑predator red fox (Vulpes vulpes).” Environmental Science &Technology, Volume 40, pages 2937 to 2943.

14)S. Voorspoels, A. Covaci, V.L.B. Jaspers, H. Neels and P. Schepens. 2007. “Biomagnification of PBDEs

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14)S. Voorspoels, A. Covaci, V.L.B. Jaspers, H. Neels and P. Schepens. 2007. “Biomagnification of PBDEsin three small terrestrial food chains.” Environmental Science & Technology, Volume 41, pages 411 to 416.

15)K. Vorkamp, M. Thomsen, K. Falk, H. Leslie, S. Moller and P.B. Sorensen. 2005. “Temporaldevelopment of brominated flame retardants in Peregrine Falcon (Falco peregrinus) eggs from SouthGreenland (1986–2003).” Environmental Science & Technology, Volume 39, pages 8199 to 8206.

16)J. de Boer, J. Aldridge, C. Allchin, M. Bennett, J.P. Boon, S. Brandsma, J. van Hesselingen, R. Law, W.Lewis, S. Morris, M.R. Tjoen-A-Choy and B. Zegers. 2001. “Polybrominated diphenylethers in theaquatic environment.” Netherlands Institute for Fisheries Research (RIVO), Report Number C023/01,Amsterdam, June 2001.

17)A. Mörck, H. Hakk, U. Örn and E. K. Wehler. 2003. “Decabromodiphenyl ether in the rat: Absorption,distribution, metabolism, and excretion.” Drug Metabolism and Disposition, Volume 31(7), pages 900–907.

18)A. Sandholm, B.-M. Emanuelsson and E. K. Wehler. 2003. “Bioavailability and half‑life ofdecabromodiphenyl ether (BDE‑209) in rat.” Xenobiotica, Volume 33(11), pages 1149–1158.

19)G.T. Tomy, V.P. Palace, T. Halldorson, E. Braekevelt, R. Danell, K. Wautier, B. Evans, L. Brinkworkthand A.T. Fisk. 2004. “Bioaccumulation, biotransformation and biochemical effects of brominateddiphenyl ethers in juvenile lake trout (Salvelinus namaycush).” Environmental Science & Technology,Volume 38(5), pages 1496–1504.

20)E. Van den Steen, A. Covaci, V.L.B. Jaspers, T. Dauwe, S. Voorspoels, M. Eens and R. Pinxten. 2007.“Accumulation, tissue‑specific distribution and debromination of decabromodiphenyl ether (BDE 209)in European starlings (Sturnus vulgaris).” Environmental Pollution, Volume 148(2), pages 648–653.

21)J. de Boer, H.A. Leslie, P.E.G. Leonards, P. Bersuder, S. Morris and C.R. Allchin. 2004. “Screening andtime trend study of decabromodiphenylether and hexabromocyclododecane in birds.” Abstract. The 3rdInternational Workshop on Brominated Flame Retardants (BFR 2004), Toronto, Canada, June 2004,pages 125 to 128.

Date issued:

2009-02-16